yywn0226

JEWELL 04 2
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00001
JEWELL 04 3
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00002
Contents
Chairman's introduction
10
Foreword from the Chairman of the Editorial Board
12
Executive summary
13
Part 1: Annual progress
14
Part 2: Clinical activity 2012.... r
,
15
Part 3: Outcomes after joint replacement 2003 to 2012
.19
Part 1 Annual progress
23
1.1 Introduction
23
1.1.1
1.1.2
1.1.3
The National Joint Registry
Management and funding
Content of the 10th Annual Report
,
.24
24
25
1.2 Data completeness and quality
1.2.1
1.2.2
Key indicators
Operation totals
26
..........
27
. , .29
1.3 Work of the NJR Steering Committee and its Sub-committees
33
1.3.1
1.3.2
1.3.3
1.3.4
1.3.5
1.3.6
1.3.7
1.3.8
34
34
35
36
,36
38
39
40
Introduction
NJR Steering Committee
NJR Editorial Board - Mr Martyn Porter, Chairman
Implant Performance Sub-committee - Mr Keith Tucker, Chairman
Surgeon Outliers Sub-committee - Professor Paul Gregg, Chairman
NJR Research Sub-committee - Professor Alex MacGregor, Chairman . .
NJR Data Quality Group - Professor Paul Gregg, Chairman
NJR Regional Clinical Coordinators' (RCC) Network - Mr Peter Howard, Chairman
1.4 Highlights
1.4.1
1.4.2
1.4.3
1.4.4
1.4.5
1.4.6
1.4.7
1.4.8
1.4.9
1.4.10
1.4.11
1.4.12
41
Geographic extension of the NJR
Extension of the NJR: Elbows and shoulders
Beyond Compliance: 'Protecting Patients, Supporting Innovation'
Publication of consultant-level data
Patient-focused initiatives
NJR Feedback Services: Updates
Proposed changes to the Minimum Dataset
Price Benchmarking
International developments
Patient Reported Outcomes Measures (PROMs)
NJR Fellowships
Orthopaedic Data Evaluation Panel (ODEP) overview
42
42
42
44
.44
44
45
45
46
46
47
47
1.5 Finance
1.5.1
Appendix 1
48
Income and expenditure 2012/13
NJR Steering Committee 2012/13..
.
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49
.50
Appendix 2
Appendix 3
List of papers, publications and research requests using NJR data
Additional information on the NJR website
52
55
Part 2 Ciinfcal activity 2012
56
2.1 Introduction
56
2.1.1
5.7
Hospitals and treatment centres participating in the NJR
2.2 Hip replacement procedures 2012
2.2.1
2.2.2
60
Primary fotal hip replacement procedures (THR) 2012
Hip revision procedures 2012
• • • • .'62
80
2.3 Knee replacement procedures 2012
2.3.1
2.3.2
84
Primary knee replacement procedures 2012
Knee revision procedures 2012
86
101
2.4 Ankle replacement procedures 2012
103
2.4.1
2.4.2
104
109
Primary ankle replacement procedures 2012
Ankle revision procedures 2012
2.5 Elbow replacement procedures 2012
111
2.5.1
2.5.2
2.5.3
112
115
116
Primary elbow replacement procedures 2012 (nine months)
Elbow revision procedures 2012
Elbow components used in primary and revision procedures,
2.6 Shoulder replacement procedures 2012
2.6.1
2.6.2
2.6.3
Primary shoulder replacement procedures 2012 (nine months) .
Shoulder components used in priman/ procedures
Shoulder revision procedures 2012 (nine months)
117
,
,
118
121
. .121
Part 3 Outcornes after joint replacement 2003 to 2012
123
3.1 Summary of data sources and linkage
123
3.2 Outcomes after primary hip replacement
126
3.2.1
3.2.2
3.2.3
3.2.4
3.2.5
3.2.6
3.2.7
3.2.8
128
131
136
140
144
148
150
158
Overview of primary hip surgery
Revisions after primary hip surgery
Revisions for different causes after primary hip surgery
Revisions after primary hip surgery for the main stem-cup brand combinations
Revisions after primary hip surgery; Effect of head sizes for polyethylene liners
Mortality after primary hip surgery
In-depth study: Metal-on-metal hip resurfacing
Conclusions
3.3 Outcomes after primary knee replacement
159
3.3.1
3.3.2
3.3.3
.160
165
.169
OverView of primary knee surgery
Revisions after primary knee surgery .
Revisions for different causes after primary knee surgery
,
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3.3.4
3.3.5
3.3.6
Revisions after primary knee surgery by main brands for TKR and UKR
Mortality after primary knee surgery
Conclusions
,
.•••..,
.•••••.
.173
179
,181
3.4 Outcomes after primary ankle replacement
182
3.4.1
3.4.2
3.4.3
183
184
184
Overview of primary ankle surgery
Revisions after primary ankle surgery
Mortality after primary ankle surgery
3.5 PROMs outcomes
186
3.5.1
3.5.2
3.5.3
3.5.4
3.5.5
187
187
.188
196
201
Background to Patient Reported Outcome Measures (PROMs)
Data linkage from PROMs to HES to NJR
PROMs outcomes for primary hip replacements
PROMs outcomes for primary knee replacements
Conclusions
Part 4 Trust™, Local Health Board- and unit-level activity and outcomes 2012
202
4.1 Introduction
202
4.2 Unit outlier analysis methodology
204
Trust-, Local Health Board- and unit-level data
206
Pari 1 tables
Table 1.1
Table 1.2
Table 1.3
Total joint replacement procedures entered into the NJR, 2008/09 to 2012/13, recorded by
country in which the procedure took place
29
Total joint replacement procedures entered into the NJR, 2008/09 to 2012/13, recorded by procedure type 30
Proportion of reported procedures by type of provider, 2008/09 to 2012/13
31
Pari 1 figures
Figure 1.1
Figure 1.2
Compliance, Consent, and Linkability Rates from 2008 to 2013
Beyond Compliance data flow
.28
43
Part 2 tables
Table 2.1
Table 2.2
Table 2.3
Table 2.4
Table 2.5
Table 2.6
Table 2.7
Total number of hospitals and treatment centres in England and Wales able to participate in the
NJR and the proportion actually participating in 2012
Number of participating hospitals, according to number of procedures performed during 2012
Procedure details, according to type of provider for hip procedures in 2012
Patient characteristics for primary hip replacement procedures in 2012, according to
procedure type
Age and gender for primary hip replacement patients in 2012
Indications for hip primary procedure based on age groups
Surgical technique for primary hip replacement patients in 2012
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58
58
.61
.64
65
.66
.71
Table 2.8
Thromboprophylaxis regime for primary hip replacement patients, prescribed at time of operation
Table 2.9
Reported untoward intra-operative events for primary hip replacement patients in 2012,
Table 2.10
73
according to procedure type
73
Patient characteristics for hip revision procedures in 2012, according to procedure type
81
Table 2.11
Indication for surgery for hip revision procedures 2008 to 2012
82
Table 2.12
Components removed during hip revision procedures in 2012
82
Table 2.13
Components used during single-stage hip revision procedures in 2012
83
Table 2.14
Procedure details, according to type of provider for knee procedures in 2012
85
Table 2.15
Patient characteristics for primary knee replacement procedures in 2012, according to
procedure type
87
Table 2.16
Age and gender for primary knee replacement patients in 2012
91
Table 2.17
Characteristics of surgical practice for primary knee replacement procedures in 2012,
according to procedure type
Table 2.18
of operation
Table 2.19
97
Reported untoward intra-operative events for primary knee replacement patients in 2012,
according to procedure type
Table 2.20
95
Thromboprophylaxis regime for primary knee replacement patients, prescribed at time
Patient characteristics for knee revision procedures in 2012, according to procedure type
98
102
Table 2.21
Patient characteristics for primary ankle replacement procedures in 2012
105
Table 2.22
Age and gender for primary ankle replacement patients in 2012
.106
Table 2.23
Characteristics of surgical practice for primary ankle replacement procedures in 2012
Table 2.24
Thromboprophylaxis regime for primary ankle replacement patients, prescribed at
Table 2.25
107
time of operation
108
Reported untoward intra-operative events for primary ankle replacement patients in 2012
108
Table 2.26
Details for ankle revision procedures in 2012
109
Table 2.27
Patient characteristics for ankle revision procedures in 2012
110
Table 2.28
Details for replacement primary elbow procedures in 2012 (nine months)
112
Table 2.29
Patient characteristics of primary elbow replacement procedures in 2012 (nine months)
113
Table 2.30
Characteristics of surgical practice for primary elbow replacement procedures in 2012
Table 2.31
Thromboprophylaxis regime for primary elbow replacement patients, prescribed at
(nine months)
time of operation
114
.115
Table 2.32
Details for elbow revision procedures in 2012 (nine months)
116
Table 2.33
Details for primary shoulder procedures in 2012 (nine months)
118
Table 2.34
Patient characteristics for primary shoulder procedures in 2012 (nine months)
119
Table 2.35
Characteristics of surgical practice for primary shoulder replacement procedures
Table 2.36
Thromboprophylaxis regime for primary shoulder replacement patients,
prescribed at time of operation
121
Table 2,37
Details for shoulder revision procedures in 2012 (nine months).
122
in 2012 (nine months)
120
Part 2 figures
Figure 2.1
Percentage of participating hospitals by number of procedures per annum, 2004 to 2012
59
Figure 2.2
Figure 2.3
Primary hip procedures by type of provider 2012
Type of primary hip replacement procedures undertaken between 2005 and 2012
62
63
Figure 2.4
Figure 2.5
Age and gender for primary hip replacement patients in 2012 .
Age for primary hip replacement patients between 2003 and 2012
67
68
Figure 2.6
ASA grades for primary hip replacement patients betvyeen 2003 and 2012
69
Figure 2.7
BMI for primary hip replacement patients between 2004 and 2012
70
Figure 2.8
Bone cement types for primary hip replacement procedures undertaken between
2004 and 2012
72
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Figure 2.9
Top five cemented hip stem brands, trends 2003 to 2012
75
Figure 2.10
Top five cemented hip cup brands, trends 2003 to 2012
75
Figure 2.11
Top five cementless hip stem brands, trends 2003 to 2012
76
Figure 2.12
Top five cementless hip cup brands, trends 2003 to 2012
77
Figure 2.13
Top five resurfacing head brands, trends 2003 to 2012
.78
Figure 2.14
Femoral head size, trends 2003 to 2012
79
Figure 2.15
Hip articulation, trends 2003 to 2012
79
Figure 2.16
Primary knee procedures by type of provider 2012
86
Figure 2.17
Type of primary knee replacement procedures undertaken between 2006 and 2012
88
Figure 2.18
Implant constraint for bicondylar primary knee replacement procedures between 2006 and 2012
89
Figure 2.19
Bearing type for unicondyiar implant used in primary knee replacement procedures
undertaken between 2006 and 2012
90
Figure 2.20
Age and gender for primary knee replacement patients in 2012
92
Figure 2.21
ASA grades for primary knee replacement patients between 2003 and 2012
93
Figure 2.22
BMI for primary knee replacement patients between 2004 and 2012
94
Figure 2.23
Bone cement types for primary knee replacement procedures undertaken between 2003 and 2012
96
Figure 2.24
Top five total condylar knee brands, trends 2003 to 2012
98
Figure 2.25
Top five unicondyiar knee brands, trends 2003 to 2012
Figure 2.26
Top five patello-femoral knee brands, trends 2003 to 2012
100
99
Figure 2.27
Top five fixed hinged knee brands, trends 2003 to 2012
101
Part 3 tables
Table 3.1
Table 3,2
Table 3.3
Summary description of datasets used forsun/ivorship analysis.. :
Composition of person-level datasets for survivorship analysis
, . . . . , , . . . . , . . . . . . . . , . ,124
.125
Numbers (%) of primary hip replacements by fixation and, within each fixation sub-group,
by bearing surface
128
Table 3.4
Percentage of primary hip replacements performed each year by type of hip fixation
and constraint
Table 3.5
Distribution of consultant surgeon and unit caseload for each fixation type
Table 3.6
Age (in years) at primary hip replacement, by fixation and main bearing surface.
131
Table 3.7
Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI),
at different times after the primary operation, for each fixation/bearing surface sub-group
132
Table 3.8:
Revision rates (95% CI), expressed as number of revisions per 1,000 patient-years,
129
.130
for each recorded reason for first hip revision. Rates shown are for all revised cases and
Table 3.9
by fixation and bearing surface
Revision rates, expressed as numbers per 1,000 patient-years, for any reason, according
,
to time interval from primary operation
Table 3,10
Revision rates (95% CI), expressed as numbers per 1,000 patient-years, for each reason,
Table 3,11
by time interval from primary operation
Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) at
137
.139
139
different times after the primary operation, for cup-stem brand combinations with large
group sizes (>2,500 or >1,000 in the case of resurfacings)
Table 3.12
.141
Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI)
at different times after the primary operation for cup-stem brand combinations with large
group sizes (>10,000) with further subdivision by main bearing surface (provided the
sub-group size > 1,000)
143
Table 3.13
Kaplan-Meier estimates of the cumulative percentage mortality (95% CI), at different times
after primary hip operation, for all cases and by age/gender
149
Table L1
Table l_2
Description of comparison groups: number of cases (percentage of totai)
Predicted revision rates for 55-year-o!d males by prosthesis and head size (95% CI)
154
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Table L3
Predicted revision rates for 55-year-old females by prosthesis and head size (95% CI)
Table L4
Comparison of most commonly used brands; predicted revision rates for 55-year-old
Table L5
Reasons for revision (95% CI), expressed as incidence per 1,000 patient-years, by
155
patients (95% CI)
Table 3.14
Table 3.15
156
articulation and fixation
157
Numbers and percentages of primary knee replacements by fixation method and bearing type
161
Percentage of primary knee replacements performed each year by method of fixation
and, within each fixation group, by bearing type
162
Table 3.16
Distribution of consultant surgeon and unit caseload for each fixation type
163
Table 3.17
Age (in years) at primary operation for different types of knee replacement; by fixation and bearing type . . .164
Table 3.18
Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) at specified
times after primary knee replacement, by fixation and bearing type
166
Table 3,19
Revision rates (95% CI), expressed as number of revisions per 1,000 patient-years, for each recorded
Table 3.20
Revision rates (95% CI), expressed as number of revisions per 1,000 patient-years, for each recorded
Table 3.21
Kaplan-Meier estimated cumulative percentage probability of first revision (95% CI) of a primary total knee
Table 3.22
Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) of a
reason for first knee revision. Rates shown are for all revised cases and by fixation type
170
reason for first knee revision. Rates shown are for each fixation/bearing surface sub-group
171
replacement by main type of implant brand at the indicated number of years after primary operation)
174
primary unicompartmental knee replacement by main type of implant brand at the indicated
number of years after primary operation
Table 3.23
175
Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) of
a total knee replacement at the indicated number of years after primary operation, by main
implant brands and type of fixation and constraint
Table 3,24
176
Age and gender distribution of patients undergoing all types of primary knee replacement operations
for the period 2003 to 2012
Table 3.25
179
Kaplan-Meier estimated cumulative percentage probability (95% CI) of a patient dying at the indicated
number of years after a primary knee joint replacement operation (i) by age group and gender and
(ii) for all patients
180
Table 3.26
Number of primary ankle operations by year
183
Table 3.27
Number of primary ankles by ankle brand
Table 3.28
Reasons for ankle revision (not mutually exclusive)
Table 3.29
Overall outcomes after primaiy hip surgery
Table 3.30
Bias in Q2 completion of EQ-5D Index, EQ-5D Health Scale (VAS), Oxford Hip Score
190
Table 3.31
Changes in EQ-5D Index tor hip primaries with index scores at both time points
190
Table 3.32
Changes in EQ-5D Heaith Scale Score (VAS) for hip primaries with scores at both time points
192
Table 3.33
Changes in Oxford Hip Score for hip primaries with scores at both time points
193
Table 3.34
Overall outcomes after primary knee surgery
196
Table 3.35
Bias in Q2 completion of EQ-5D Index, EQ-5D Heaith Scale (VAS), Oxford Knee Score
197
Table 3.36
Changes in EQ-5D Index for knee primaries with index scores at both time points
198
Table 3.37
Changes in EQ-5D Health Scale score (VAS) for knee primaries with scores at both time points
198
Table 3.38
Changes in Oxford Knee Score for knee primaries with scores at both time points
198
183
.184
189
Part 3 figures
Figure 3.1
Patients with hip, knee and ankle primary operations within the survivorship data, sets
Figure 3.2
Comparison of cumulative hazard of first revision for cemented hips with different bearing
surfaces (with 95% CI)
Figure 3.3
125
133
Comparison of cumulative hazard of first hip revision for uncemented hips with different
bearing surfaces (with 95% CI)
ifl|I|l)
Vv%
,
134
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Figure 3.4
Comparison of cumulative hazard of a first hip revision for hybrid (not including reverse hybrid)
hips with different bearing surfaces (with 95% CI)
Comparison of the cumulative hazard for revision for different head sizes for
metal-on-polyethylene monobloc cup
Figure 3.5 (i)
.135
145
Figure 3.5 (ii)
Comparison of the cumulative hazard for revision for different head sizes for
metal-on-polyethylene with metal shell/poiyethylene liners
Comparison of the cumulative hazard for revision for different head sizes for ceramic-on-polyethylene
146
Figure 3.5 (iii)
with polyethylene monobloc cup
Comparison of the cumulative hazard for revision for different head sizes for ceramic-on-polyethylene
147
Figure 3.5 (iv)
Figure L1
with metal shell/polyethylene liners
Cumuiative hazard of revision after resurfacing by gender (with 95% CI)
148
152
Figure L2
Estimated cumuiative incidence of revision for 55-year-old male by prosthesis type
153
Figure L3
Estimated cumulative incidence of revision for 55-year-old female by prosthesis type
153
Figure 3.6
Cumulative hazard (x100) of a first revision for different types of primary knee replacement at
increasing years after the primary surgery (with 95% CI)
168
Figure 3.7
Comparison of the cumulative hazard (x100) of a knee prosthesis first revision for different
bearing types at increasing years after the primary surgery when the primary arthroplasty
Figure 3.8 (i)
Figure 3.8 (ii)
method of fixation was cemented only (with 95% CI)
Histogram to compare the distributions of the EQ-5D Health Scale Score (VAS) between Q1
169
and Q2 in cases with scores at both time points (n=80,394). At Q1 . . .
194
Histogram to compare the distributions of the EQ-5D Health Scale Score (VAS) between Q1
and Q2 in cases with scores at both time points (n=80,394). At Q2
Figure 3.9 (i)
194
Histogram to compare the distributions of the Oxford Hip Score between Q1 and Q2 in cases
with scores at both time points (n=92,133). At Q1
195
Figure 3.9 (ii)
Histogram to compare the distributions of the Oxford Hip Score between Q l and Q2 in cases
with scores at both time points (n=92,133). At 0 2
195
Figure 3.10 (i)
Histogram to compare the distributions of EQ-5D Heaith Scale Score (VAS) between Q1 and
Q2 in cases with scores at both time points (n=84,031). At Q l
199
Figure 3.10 (ii)
Histogram to compare the distributions of EQ-5D Health Scale Score (VAS) between Q1 and
0 2 in cases with scores at both time points (n=84,031). At Q2
199
Figure 3.11 (i)
Histogram to compare the distributions of the Oxford Knee Score between 0 1 and Q2 in
Figure 3.11 (ii)
cases with scores at both time points (n=93,353). At Q1
200
Histogram to compare the distributions of the Oxford Knee Score between Q l and 0 2 in
cases with scores at both time points (n=93,353). At Q2
200
Glossary
Glossary
232
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Laurel Powers-Freeling
It has been another busy year for the National Joint
Registry (NJR), which continues to develop and
mature as the world's largest orthopaedic registry and
show leadership in analysis and communication of
insights we glean from our rich pool of data. Normally
my 'thanks to colleagues' goes at the end of the
Chairman's Introduction, but given the extraordinary
efforts and change we have seen this year, I want
to acknowledge up-front my gratitude to the NJR
Steering Committee, and in particular to note the
outstanding contributions made by our Vice Chairman,
Professor Paul Gregg, Mr Martyn Porter, Mr Keith
Tucker, Professor Alex MacGregor and Mr Peter
Howard. Without their commitment and generosity of
time and spirit, much of the work of the NJR would
not have been possible. I would also like to thank our
partners: University of Bristol, led by Professor Ashley
Biom; Northgate Information Solutions; as well as
the NJR management team at the Healthcare Quality
Improvement Partnership, led by Elaine Young, who
receives our special thanks for her dedication and
hard work.
Historically, the data collection and analysis done by
the NJR has focused on hip and knee replacement,
and from April 2010 ankle replacement, and has done
so only for procedures done in England and Wales. In
April 2012, however, we extended our data collection
to include elbow and shoulder joint replacements,
as well as implementing a two-year pilot study of
Patient Reported Outcomes Measures for shoulders,
with data collected from patients at six months postsurgery. As well as new joint types, we have also
extended the NJR geographically with the inclusion
of data from Northern Ireland, and are currently in
discussions to incorporate data from the Isle of Man.
Given the growth and development of the NJR,
we took the opportunity in this, our tenth year of
operation, to step back and review our purpose
and strategic aims, as well as considering how our
structure, funding model and major activities support
our aims. Key developments from this review include
the establishment of a new Executive Committee to
handle the rapidly expanding day-to-day management
of the NJR; establishment of a new Medical Advisory
Committee intended to provide a forum to gather
views from our medical stakeholders, in particular the
medical societies; the creation of a new NJR Medical
Director executive post to partially relieve the burden
carried by volunteers on the Steering Committee;
and, we have established a formal Patient Network
to ensure that the voice of the patient is heard in all
the work we do. In addition, we plan to broaden the
membership of the NJR Sub-committees to include
a wider representation of stakeholders than those
exclusively on the NJR Steering Committee. Work is
ongoing to finalise these arrangements.
In September 2012, we launched our new Annual
Clinical Reports, which were circulated to Trust,
Local Health Board and independent provider
Chief Executives detailing a range of performance
information for their hospitals. This was a major step
forward in providing units with feedback on the data
held for them by the NJR.
Another important initiative in which the NJR has
been an integral member is the establishment of the
initiative Beyond Compliance, which invites implant
manufacturers on a voluntary basis to go beyond
the requirements of the implant CE mark and enter
a rigorous, ongoing monitoring process for newlydeveloped implants. The NJR supports the British
Orthopaedic Association and the Medicines and
Healthcare products Regulatory Agency, who are the
joint leaders of this programme, by providing data and
operational support. We are proud to be a part of this
world-leading development.
In support of better cost-effectiveness of implant
purchasing by Trusts, the NJR was commissioned by
the Department of Health under the QIPP Orthopaedic
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Procurement Group (see page 45) to look at pricing
data across NHS Trusts and Local Health Boards in
England and Wales; 35 units have been involved in
the pilot study to date. By matching actual cost data
with NJR data, a potential suite of tools will enable
healthcare organisations to analyse and compare
spend and usage of orthopaedic implant products.
The goal is to develop a model that can be
extended nationally.
NHS England recently announced through the
'Everyone Counts' initiative that outcome of surgery at
individual consultant level would be published by the
end of June 2013 for ten clinical areas, one of which is
hip and knee, and which is supported by data from the
NJR. At the same time, the NJR has also developed
a surgeon and hospital profile system that has been
used as the publication vehicle. The magnitude and
complexity of this exercise for orthopaedics has relied
on a huge amount of work and collaboration between
the NJR and the British Orthopaedic Association,
with support from the specialist societies, the British
Association for Surgery of the Knee and the British Hip
Society. Despite very tight deadlines, we were able
to publish data on the new NJR system, which we
intend to develop further in the coming year to provide
surgeons and trusts with the ability to customise
profiles that are made available to the public.
In June this year, the NJR hosted the 2nd Annual
Congress for the International Society of Arthroplasty
Registries (ISAR) in Stratford-upon-Avon, providing
us with an opportunity to showcase our work and
influence the development of future international
cooperation. We look forward to the 3rd ISAR
Congress in Boston, USA in 2014.
and with intentions to make a further appointment
this year.
* CoFi Co ana a a loaf loo a ~ we have developed a
new communications strategy for 2013/14, which
has included the recent launch of NJR social media
platforms, including Twitter, Facebook and our
first eBulietin news service, with more innovations
planned for next year.
* Cow Aooool Report format - work is ongoing
that will see NJR Annual Reporting data presented
online, taking into accounta stakeholder survey of
preferences and views.
Finally, we will be holding a special celebration of the
NJR's '10th Birthday' this September with a special
stakeholder reception to launch this Annual Report.
While I gave my thanks to colleagues at the beginning
of this introduction, I would like to close by mentioning
the members of the NJRSC who will be steppingdown during 2013/14, which include Professor Paul
Gregg, Mick Borroff and Professor Alex MacGregor
- all of whom have been on the Steering Committee
since its inception. I would also like to thank Andrew
Wood head who has served on the NJRSC since
2007, and Dean Sleigh who stepped down in March
2013 and has served on the NJRSC since 2008. Each
of them can rightly take pride in having built the NJR
and in the importance of the work we do today.
Yours sincerely,
As we move from this year to next, the NJR has a
number of new activities and plans that we believe will
further support our stakeholders, including;
•* Patient implant Cards- •• we are undertaking a
pilot study with the aim of introducing a patient
implant card designed to improve online access to
information for patients and also provide feedback to
the NJR.
Laurel Powers-Freeling
Chairman, National Joint Registry Steering Committee
* CJR Faansarch Fallows ~ due to the success of
the NJR Research Fellows posts, the programme
will continue, with one new Fellow now appointed
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The 2013/14 year marks the 10th anniversary of the
National Joint Registry. By 31 March 2013 the NJR
held more than 1.4 million records and nearly 200,000
submissions were received on hip, knee, ankle, shoulder,
and elbow replacements. The in-year compliance is over
90% and the overall compliance, since 2003, is 86.8%.
It was interesting to note that 55% of joint replacement
activity carried out in independent hospitals was funded
by the NHS.
The previous trend in terms of the uncemented fixation
continues and the use of metal-on-polyethyiene and
ceramic-on-ceramic bearings predominate. The use of
the metal-on-metal articulation has declined to very low
levels. The knee replacement trends continue very much
as they have done over the lifespan of the registry with
the posterior cruciate retaining bicondylar cemented knee
being the procedure of choice. Despite higher observed
revision probability with the unicondylar knees these have
still maintained about 8% of the market.
An important change this year in Part Three of the report
has been the use of the Kaplan-Meier survivorship
estimates for all information in the tables instead of
the Nelson-Aalen cumulative hazard used previously,
although the latter technique has been used for the
graphs. The details of this are explained in Part Three
itself. It is also important to note that the data has not
been fully risk adjusted. Instead it has been presented
according to a combination of fixation attributes and in
the larger groups also with different bearing attributes
as we did last year. Instead of considering survival of a
single component, both the stem and cup brand have
been considered together and in the larger groups further
broken down in relation to the bearing used within the
brand companies. This allows a more realistic view on
the effect of the 'whole' hip replacement. However, as
the data has not been fully risk adjusted care needs to
be taken interpreting the results and, as always, I would
recommend looking at the upper and lower confidence
intervals around the mean to ascertain whether any
differences are likely to be statistically significant.
For the first time Patient Reported Outcome Measures are
reported. This represents a major step forward looking
at other factors apart from revision which may affect
the outcome. It is still relatively early days both in terms
of understanding how this data should be statistically
analysed and how the findings should be incorporated.
With such a large database the NJR is clearly having a
larger influence on the evidence base. However, it will
probably take another ten years before the full effects and
benefits of bearing performance are fully appreciated.
The availability of new materials and a better
understanding of the biomechanics of joints have resulted
in many new innovations being available to orthopaedic
surgeons. An important role of the NJR has been to
maintain a close surveillance on the early adoption of new
technologies and our implant performance Scrutiny Group
regularly review clinical publications and results reported
by international registries. It is important that this review of
other data takes place because the numbers of any new
product implanted in one country are often too smail for
any definitive decisions on performance to be made within
the first couple of years following the initial implantations.
The planning for the 11th Annual Report is already
underway and I would like to point out that the format
of next year's report is likely to be significantly different.
We are intending to concentrate on providing online and
interactive report features. The traditional printed report
will be a much briefer summary and in this context the
10th Annual Report is likely to be last of the larger
report formats.
Once again I would like to thank everybody who has
contributed to the registry, not least to the patients for
allowing their data to be recorded and to all surgeons for
entering their data in to the NJR.
M l
Pl
Martyrs Porter
Chairman, Editorial Board
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
JEWELL 0 54
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00013
The 10th Annual Report of the National Joint Registry
for England, Wales and Northern Ireland is the formai
public report for the period 1 April 2012 to 31 March
2013 (Part One). Also included are statistics on joint
replacement activity for the period 1 January to 31
December 2012 (Part Two) and survivorship and
more detailed statistical analysis on hip and knee
joint replacement surgery using data from 1 April
2003 to 31 December 2012 (Part Three). Part Four
shows indicators for hip and knee joint replacement
procedures by Trust and unit based on the 2012
calendar year.
The NJR began collecting data on hip and knee
replacement operations on 1 April 2003. Data
collection on ankle replacements began on 1 Aprii
2010 and on shoulder and elbow replacements on 1
April 2012. Data collection in Northern Ireland began
in February 2013. The total number of procedures
recorded in the NJR exceeded 1.4 million records by
31 March 2013, with 2012/13 having the highest ever
annual number of submissions at 196,403.
The NJR uses rates of compliance (case
ascertainment), patient consent, and linkability (the
ability to link a patient's primary procedure to a revision
procedure) as its key data quality indicators. Details of
how these are calculated are included in the report. At
91 %, 2012/13 saw the highest annual rate of consent
recorded, whilst linkability remained constant at 96%.
The NJR Steering Committee and its sub-committees
are vital to the running and development of the NJR.
A key focus of the steering committee throughout the
last year has been to review the NJR's priorities and its
governance and operating model, in recognition of the
great increase in scope and responsibilities of the NJR
since its formation in November 2002.
NJR Editorial Board, and the NJR Data Quality Group.
The reports from the respective Chairman of the
Implant Performance Sub-committee and the Surgeon
Outlier Sub-committee outline how outlier analysis is
undertaken and include the high level outcomes of the
monitoring process for 2012/13.
The work of the NJR has continued to expand
throughout 2012/13. In April 2012, details of shoulder
and elbow joint replacement procedures were
added to the data collection, Northern Ireland joined
the NJR in February 2013, and the NJR began the
next phase of its PROMs study: the follow up, at
three years, of approximately 43,000 hip and knee
replacement patients. The report also outlines two
other major developments being supported by the
NJR: Price Benchmarking and Beyond Compliance.
Price Benchmarking is sponsored by the Department
of Health and is currently in the second phase of its
pilot. The service, when fully implemented, will provide
a comparison of implant prices across NHS England
and NHS Wales. Beyond Compliance is a voluntary,
post-market surveillance process that goes beyond the
normal, regulatory requirements for the introduction,
to market, of new implants. Using a central data
repository consisting of data from numerous sources,
new implants can be more closely followed up with the
intention of them being introduced to market in a more
controlled fashion than has been possible previously.
The NJR has continued to increase its presence
internationally and is a full member of both the
International Society of Arthroplasty Registers (ISAR)
and the Internationa! Consortium of Orthopaedic
Registers (ICOR). The NJR recently hosted ISAR's 2nd
Annual Congress (June 2013).
The report highlights the ongoing work of the Implant
Performance Sub-committee, the Surgeon Outlier Subcommittee, the NJR Research Sub-committee, the
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Part Two of the NJR TOth Annual Report includes data
on clinical activity•- volumes and surgical technique, in
relation to hip, knee and ankie procedures carried out
in England and Wales between 1 January 2012 and
31 December 2012. It also includes information on
elbow and shoulder prostheses between 1 April 2012
and 31 December 2012. To be included in the report
all procedures must have been entered into the NJR
by 28 February 2013.
During 2012 there were 413 orthopaedic units that
were active and this included 240 NHS hospitals and
163 independent units. The remaining units were
independent sector treatment centres. A total of 96%
of units submitted at least one procedure carried out
within the calendar year 2012 to the NJR. The average
number of hip replacements submitted per unit was
218 and for knee replacement 235.
Just over 1 % of activity in NHS hospitals is
independently funded but in independent hospitals the
majority of work (55%) is now funded by the NHS.
Hip replacement procedures
A total of 86,488 hip procedures were recorded on the
NJR in 2012 which represented a 7.5% increase from
last year. Of these 76,448 were primary and 10,040
were revision procedures. The 'revision' burden now
stands at 12% of total hip activity compared to 11 % in
2011. In terms of fixation of hip replacement in 2012
the trend was very similar to 2011 where cementless
fixation predominates at 43% with a slight reduction in
cemented hip replacement to 33% (compared to 36%
last year) and a slight increase in the use of hybrid
fixation at 20% (compared to 18% last year). The
use of hip resurfacing has now fallen to 1 % and large
head metal-on-metal replacements to 2%. Patient
characteristics have remained fairly constant with an
average age of 68.7 years and a predominance of
female patients (60%).
The proportion of patients within age ranges has
remained virtually the same in the 10 years that the
NJR has been recording data with about one third of
patients being in the age range 70 to 79 and just over
1 % being less than 40 years at the time of surgery.
The average body mass index (BMI) increased very
slightly to 28.7 compared to 28.6 in 2011.
The ASA distribution is identical to last year with
only 15% being ASA grade 1 and the majority of
patients being ASA grade 2. However, there were
important differences in patients ASA grades between
those treated within NHS hospitals compared to
independent hospitals. For example, 21 % of patients
treated in NHS hospitals had an ASA grade 3
compared to just 7% in independent hospitals and
patients with ASA grade 1 (fittest patients) were
just 11 % in the NHS and almost double (21 %) in
independent hospitals. These data would suggest
that a much fitter cohort of patients are treated in
independent hospitals which is important when
comparing outcomes between these two sectors.
As previously noted, both the age and gender of
the patient have strong associations with the type
of replacement carried out. For example, in female
patients less than 50 years of age about 68% were
cementless replacements compared to just 21 % in
the age range between 80 and 89.
The most common diagnosis was osteoarthritis but
again the age of the patient had a strong influence
on the diagnosis and in young patients, as expected,
there was a much higher incidence of patients with
a diagnosis of avascular necrosis and hip dysplasia
compared to the more elderly cohort of patients.
The surgical techniques were very similar to those
recorded in 2011, the lateral position being used in
93% of cases and a slight increase in the use of the
posterior approach to 61 % compared to 59% last year.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Minimally-invasive surgery (MIS) was recorded as
being used in 5% and image-guided surgery was used
very infrequently in just 0.3% of cases.
In terms of thromboprophylaxis a multi-modal
regime was commonly used with low molecular
weight Heparin being used in 73% of cases and TED
stockings in 66%.
In 2012, 146 brands of femoral stem, 101 brands of
acetabular cup and eight brands of resurfacing cup
were used. Using the Orthopaedic Data Evaluation
Panel (ODEP) ratings only about half of all femoral
and acetabular components had an ODEP rating
in primary arthroplasty. However, the components
used with the full 10A benchmark rating was 88% for
cemented stems, 69% for cementless stems, 34% in
cemented cups, 3% for cementless cups and 63% for
resurfacing cups.
In terms of brand choice the Exeter V40 stem was
most commonly used in 66% of cemented hips and
the contemporary cup used in about 34% of cases. A
rapid rise of the Exeter rim fit cup introduced in 2010
was observed. This now has a market share of about
12%, obtained in a very short time period.
In regard to cementless fixation the Coraii stem has
maintained its position as the most commonly used
stem in about 46% of cases and the Pinnacle socket
in 33%. The use of resurfacing in 2012 fell to 1,075
compared to 1,883 in 2011. The Birmingham hip
resurfacing is the most popular implant used.
The preference to use large diameter heads to
improve stability continues with about 30% of femoral
heads being 36 millimetres, another 30% being 32
millimetres and nearly 40% being 28 millimetres. Head
sizes over 36 millimetres are now only rarely used as is
the smaller head size of 22.25 millimetres.
in terms of bearing combinations the use of metalon-polyethylene (this includes standard and cross link
polyethylene) remains the most common selection in
just under 60% of cases followed by a ceramic-onceramic articulation. There is a slight increase in the
use of ceramic-on-polyethylene and the use of metalon-metal articulation continues to fail.
There were 10,040 hip revision procedures recorded
in 2012 of which 88% were single-stage revisions.
Aseptic loosening was the most commonly recorded
indication for revision surgery in 40%, infection in 12%
that increased to 13% for adverse soft tissue reactions
(1,330 cases). Patients undergoing revision surgery are
less fit than patients undergoing primary replacement
with one third of patients being graded as ASA grade
3 for staged revision surgery. NHS hospitals incurred
most of the burden of revision operations - 83%
compared to independent hospitals 15%. This differs
to the activity of primary surgery where NHS hospitals
carried out 69% of primary surgery compared to 27%
in the independent sector. When the revision is carried
out in a single operation both the cup and stem are
removed in 45% of cases, the acetabular component
only in 30% and the femoral stem only in 14%. The
revision components used during single-stage hip
revision is approximately equal between cemented
and cementless (28% versus 29%) whereas on the
acetabular side cementless components are used
three times more frequently (58% versus 18%) than
cemented components.
Knee replacement procedures
In 2012, 90,842 knee replacement procedures were
entered into the NJR representing an increase of 7.3%
compared to 2011. In these procedures 84,833 were
primaries and 6,009 were revision procedures. The
revision burden of knee replacement is just over 6.5%
which is just over half of the revision burden of hip
replacements. The type of knee replacements used
has remained remarkably constant over the last three
to four years with 86% being cemented total knee
replacements, 8% being unicondyiar replacements,
3% total knee replacements not using cement and
only about 1 % being patello-femoral replacements.
In terms of surgical technique a medial parapatellar
approach was used in 93% of procedures. MIS
was used in just 2% of total knee replacements but
much more frequently in unicondyiar replacements
(46%). The patella was resurfaced in 38% of primary
cemented knee replacements but in just 7% of
cementless total knee replacements. As in hip
replacements thromboprophylaxis tended to be multimodal with low molecular weight Heparin being used
in 72% of cases and TED stockings in 70%. The RFC
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Sigma was the most commonly used total condylar
knee replacement being used in just under 37% of
cases. For the unicondylar replacement there was a
slight decrease in the use of the Oxford which had just
over 60% of the market share.
A total of 6,009 knee revision procedures were
reported in 2012 representing an increase of 17%
compared to 2011. The vast majority of these
(78%) were single-stage revision operations. As
in hip revisions, patients undergoing revision knee
replacements tended to be less fit than patients
undergoing primary replacement and 85% of the
revisions were carried out within NHS hospitals
compared to 69% of primaries indicating that it is the
NHS that picks up a disproportionate amount of the
knee revision burden. Indications for revision surgery
were recorded as aseptic loosening in 32% of cases
and infection in 22%.
Ankle replacement procedures
This is only the second full year of recording ankle
replacements with data collection starting on 1 April
2010. The compliance has improved from 64% last
year to 77%.
Of the ankle replacements recorded for the calendar
year 2012 there were 590 ankle replacements including
540 primaries and 50 revisions. The majority, 86%,
were funded by the NHS and the patient characteristics
in terms of ASA and BMI were not dissimilar to that of
patients undergoing hip and knee replacement. Unlike
hip replacements male gender was recorded in 58%
of cases and osteoarthritis was the most common
diagnosis in 84% and inflammatory arthritis in 13%.
Additional information is recorded on ankles including
tibia-hindfoot alignment of 46% being in neutral position
and the range of ankle dorsiflexion, 42% having
dorsiflexion between five and 20 degrees and 54%
having plantarflexion between five and 15 degrees.
In terms of surgical technique the anterior approach
was the most common in 97% and in 11 % Achilles
tendon lengthening was carried out. Bone grafts were
used in 15%.
For prophylaxis low molecular weight Heparin was
used in 80%. 56% had TED stockings but there was
less reliance on calf or foot compression compared to
hip and knee replacements.
The main implant used was the DePuy Mobility
in 52% followed by the Zenith ankle replacement
manufactured by Corin in 20%.
Of the 50 ankle revision procedures most, 46, were
carried out on the NHS. The main indicators for revision
were undiagnosed pain (36%), suspicion of infection
(26%), aseptic loosening of the tibial component (18%)
and aseptic loosening of the talar component (16%).
Elbow replacement procedures
This is the first year that we have reported on elbow
replacement and shoulder replacement surgery with
data collection starting on 1 April 2012 and therefore
the reporting period is nine months rather than the full
calendar year..
There were 288 elbow replacement procedures which
include 214 primary and 74 revision procedures.
Many of the revision procedures clearly relate to
previous periods of implantation. 89% of the primaries
were total replacements and 9% were radial head
replacements. The indications for surgery were more
variable compared to other procedures in this report
with osteoarthritis only comprising 32%, inflammatory
arthritis 33% and trauma or trauma sequelae
comprising a further 37%. The average age of patients
was 65 (female) and 67 (male). 89% were treated in
the NHS.
The posterior approach was used in 89% of cases and
humeral bone graft in 16%. 59% had low molecular
weight Heparin and 54% TED stockings.
Of the 74 revision procedures, 50% were carried
out for aseptic loosening, 18% for infection, 12% for
instability and 19% for peri-prosthetic fracture. The
Coonrad Morrey prosthesis manufactured by Zimmer
had 45% of the market share.
Shoulder replacement procedures
Shoulder replacements are again reported for nine
months of the calendar year 2012 for reasons
explained under the elbow section.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
A total of 2,225 shoulder replacement procedures
were recorded including 1,968 primaries and 257
revisions. Of the primary procedures there was quite a
diverse mix of prostheses with 27% being primary total
replacements, 15% hemi-arthroplasty, 6% resurfacing,
22% hemi-resurfacing and 30%, or 597, reverse
prostheses. Osteoarthritis was the primary diagnosis
in 61 % of cases but 24% of patients were reported
to have cuff tear arthropathy. The mean age of female
patients (73.2 years) was greater than that of male
patients (68,8 years) and 72% of patients were female.
The most common surgical approach was the Delta
pectoral approach in 75%. Humeral bone graft was
used in 12%. A tenotomy of the long head of biceps
was carried out in 45% of patients and the rotator cuff
condition was described as normal in just 43%. 57%
of patients received low molecular weight Heparin.
Of the 257 revision procedures, the indications for
surgery were variable; just 14% for aseptic loosening,
30% were conversion of hemi to total and 25% were
revision for cuff insufficiency.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Part Three of the 10th Annual Report descnoes the
clinical outcomes represented by survivorship data
and mortality in relation to hip and knee replacements
carried out in England and Wales between 1 April
2003 and 31 December 2012. This represents nearly
ten years of survivorship information.
It also includes for the first time pre- and postoperative Patient Reported Outcome Measures
(PROMs) collected since April 2009.
The National Joint Registry contains over 1.4 million
operations but because of exclusions in relation to
patient identifiers, iinkage issues and other causes, the
survivorship analysis was based on 539,372 primary
hips with 11,780 linked first revisions, 589,028 primary
knees and 11,666 linked first revisions and 1,417
ankles with 9 linked first revisions.
This year we have used Kaplan-Meier estimates and
the cumulative chance of revision of first implant or
death of patient but we have continued to use NeisonAalen cumulative hazard estimates for the graphs.
Details of these statistical methodologies are explained
in the appendices to this report.
Hip replacement, procedures
The data describes the number of patients and
percentages of implant fixation combinations with
those of bearing surface combinations and illustrates
the change of usage of both fixation and bearing
between 2003 and 2012 inclusive. This shows
interesting changes over the years, for example in
2003, 55,3% of all hip replacements were metal-onpoiyethylene cemented replacements but in 2012 this
has nearly halved to just 28.6%. In comparison the
rmetal-on-polyethylene uncemented hip replacement
was used in just 6.2% of cases in 2003 and this has
almost trebled to 17.8% in 2012. The ceramic-onceramic uncemented hip replacement has also shown
a rapid increase from just 3.5% in 2003 to a nearly six
fold increase to 19.2% in 2012. The use of metal-on-
metal resurfacing peaked at 10.8% in 2006 and was
just 1.3% in 2012.
The unadjusted Kaplan-Meier survivorship estimates
are presented for each of these fixation and bearing
combinations within the report. The lowest revision rate
at nine years was that of the ceramic-on-polyethylene
cemented hip replacement with a cumulative probability
of first revision of just 1.84% (95% Ci of 1.51 %
to 2.24%). Considering all bearing combinations
overall, cemented hip replacement had a cumulative
percentage revision probability of 2.71 % (2.57% to
2.87%) at nine years after operation compared to
6.71% (6.40% to 7.05%) with uncemented fixation,
once again the ceramic-on-polyethylene bearing had
the lowest revision rate within the uncemented fixation
group. The hybrid and reversed hybrid groups were
somewhere between the cemented and uncemented
fixation groups with a nine-year revision probability of
3.42% (3.10% to 3.76%) for hybrids and 3.37% (2.52%
to 4.33%) for reverse hybrids.
When a metal-on-metal articulation was used with
cementless fixation the nine-year revision probability
of a first implant was 17.66% (15.93% to 19.56%).
This was similar to the metal-on-metal resurfacing
which had a revision probability of 12.31 % (11.62% to
13.04%) at nine years.
The number of revisions by indication for revision are
presented per 1,000 patient-years for fixation and
bearing, for example for dislocation/subluxation there
were 0.89 (0.83-0.96) revisions per 1,000 patientyears with cemented fixation but this was just 0.43
(0.34 to 0.53) when meta!-on-metal resurfacing was
used. Soft tissue reaction was recorded in 0.02
(0.01 to 0.05) of cemented metal-on-polyethy!ene
replacements compared to 3.55 (3.05 to 4.13) of
metal-on-metal resurfacing and 5.50 (4.90 to 6.20) of
metal-on-metal uncemented replacement. The revision
rates following surgery were not linear, for example
the revision rate for 1,000 patient-years within one
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
year of surgery was 7.71 (7.47 to 7.96) but this fell to
4.60 (4.45 to 4.75) between one and three years from
primary operation.
The Kaplan-Meier cumulative probabilities of a first
prosthesis revision are listed for a large number of cup
stem brand combinations. For example, the cemented
Exeter V40 - Elite Plus Ogee socket combination had
a revision probability after nine years of 1.57% (1.30%
to 1.90%) and the uncemented Furlong HAG stem CSF had a cumulative probability of first revision nine
years after surgery of 2.97% (2.59% to 3.40%).
For the cup stem brand combinations with over
10,000 cases the brand combinations were further
broken down to examine the effect of bearing surface,
for example, the Exeter V40 Contemporary metalon-polyethylene bearing had a nine-year first revision
probability of 2.33% (2.00% to 2.70%) but when
the ceramic-on-polyethylene bearing was used with
the same brands the cumulative chance of revision
after nine years was 1.87% (1.20% to 2.90%). The
Corail Pinnacle group was interesting as the effect of
the bearing could be clearly seen. Eight years post
surgery, the chance of first revision was 5.89% (5.11 %
to 6.79%). However, within this group with a Corail
Pinnacle combination, if a ceramic-on-polyethylene
bearing was used the probability of first revision was
just 1,84% (1.34% to 2.51 %) whereas when a metalon-metal bearing was used the cumulative probability
was 11.10% (9.06% to 13.58%).
With resurfacing clear differences could be seen
between the brands. Eight years after the primary
surgery, the probability of first revision with the
Birmingham hip (BHR) resurfacing was 6.61% (6.12%
to 7.13%) compared to 29.69% (27.03% to 32.55%)
when the ASR was used.
Cumulative revision probabilities were also considered
as a function of head size and head material when
used with a polyethylene liner. This allowed multiple
comparisons, for example, when a metal head
was used with a polyethylene liner contained in a
metal shell, the revision probabilities were higher for
the larger 44 millimetre head compared to the 28
millimetre head.
The cumulative probability of death at different times
after the primary/ surgery is presented broken down
by gender and age group. The risk of death within 90
days of surgery overall was 0.51 % (0.50% to 0.53%).
In female patients this ranged from 0.21 % (0.16%
to 0.27%) in patients less than 55 years to 1.31 %
(1.22% to 1.41 %) in patients 80 years and above and
at nine years after primary surgery the cumulative
probability of death in male patients less than 55 years
was 4.39% (3.88% to 4.96%) compared to 65.67%
(63.62% to 67.72%) for patients aged 80 and above.
One of the in-depth studies, that of metal-on-metal
hip resurfacing was published in The Lancet in
October 2012. In this paper the effects of age, gender
and femoral head size are considered and the best
outcomes were observed in male patients aged 55
years with a head size of 54 millimetres where the
revision rate at seven years was 2.47% (1.90%
to 3.20%).
Knee replacement procedures
In comparison to hip replacements, the changes in
fixation, constraint and type of knee replacement has
not varied as much over the observation period 2003
to 2012. The use of cemented total replacements
increased from 81.5% in 2003 to 86.9% in 2012
and within cemented groups the unconstrained
(posterior-cruciate retaining) fixed knee increased
from 53.3% in 2003 to 59.8% in 2012. Despite some
concerns with higher revision rates seen amongst
unicondylar replacements, the use of these remains
fairly static between 8% and 9% and similarly for
patelio-femoral replacements (which are relatively low
volume), the use of these ranged from just 1.0% in
2003 to 1.3% in 2012.
It was reassuring that the most commonly used
replacement, the all cemented total replacement
unconstrained and fixed, had a low cumulative
probability of first revision of just 2.90% (95% CI of
2.77% to 3.04%) at nine years. The cemented mobile
constrained condylar knees had a revision probability
of 4.48% (2.87% to 6.96%) at nine years. With
uncemented and hybrid replacements the posteriorstabilised knees had a revision probability of 6,70%
(5.15% to 8.70%) at nine years. As previously noted
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
unicondylar knees had a high revision probability of
11.57% (10.92% to 12.26%) at nine years and the
patello-femoral replacement had a revision probability of
16.11 % (14.09% to 18.39%) at the same time period.
probability of death was 3.55% (2.88% to 4.37%) at
nine years compared to 51.00% (49.55% to 52.46%)
in patients 80 years or older.
Ankle replacement procedures
The stated reasons for revision by fixation are described
as revision rates per 1,000 patient-years. The revision
rate was 1.10 (1.06 to 1.15) revisions for infection and
for component size mismatch 0.73 (0.70 to 0.77). There
was a further breakdown of reasons for revision by
fixation and degree of constraint.
The revision probabilities are described up to nine
years following surgery for the main brands; compared
to hip replacement there was less variation in revision
probability. For example, the PFC Sigma bicondylar
knee had a cumulative revision probability of 2.45%
(2.30% to 2.61 %) at nine years and the Genesis 2
2.43% (2,11 % to 2.79%), Some knees performed less
well including the Kinemax with a revision probability
of 4.30% (3.81 % to 4.86%) at nine years and the
Rotaglide Pius which had a revision probability of
5.45% (4.19% to 7.07%). When patello-femoral joints
were considered the seven-year revision probability
of the Avon knee was 10.94% (9.49% to 12.60%) but
for the Journey PFJ Oxinium it was 17.52% (12.98%
to 23.41%). There was also variation with unicondylar
knees, for example the Zimmer unicompartmental
knee had a revision probability of 5,27% (4.15% to
6.69%) at nine years compared to the Preservation
which had a revision probability of 17.31 % (14.43%
to 20.68%).
When considering the type of constraint within the
brand class there was generally low variation but
there were some differences, for example within the
Nexgen brand the cumulative revision probability
with a cemented unconstrained fixed tibial insert was
2,44% (2.03% to 2.93%) at nine years compared to
3.62% (3.20% to 4.41 %) when the Nexgen posteriorstabilised fixed insert was used.
The cumulative probability of patient death at different
times after knee replacement had a similar pattern
to that of hip replacement. For all cases the 90-day
mortality probability was 0.36% (0.34% to 0.39%).
At nine years this increased to 22.27% (21.95% to
22.59%). in female patients less than 55 years the
Because of the more recent inclusion of ankles and
relatively small numbers, limited data are presented
on ankle replacements. There were 1,417 primary
operations in a population with a median age of 67
years, 57,2% of patients were male, Nearly all the
ankle replacements were cementless. The Mobility
brand was used in 56.5% of cases. There were only
nine revisions, recorded. Mortality was relatively low
following ankle surgery with a 90-day cumulative
mortality of 0,1.4% (0.04% to 0.58%) and a two-year
cumulative probability of 1.40% (0,69% to 2.83%).
Patient Reported Outcome Measures. (PROMs)
For the first time the NJR reports On PRGMs. PROMs
data, which is part of an NHS-funded initiative, is
collected separately from the NJR. This collection
has only been in action since April 2009 and relates
to a pre-operative questionnaire and a follow-up
questionnaire about six months following surgery.
Data includes EQ-5D Index, EQ-5D Health Scale and
Oxford Hip/Knee scores.
The original PROMs data file had 445,134 entries
but for a variety of reasons a substantial proportion
of these entries could not be matched to NJR data
because of data quality issues, duplication and
incomplete data.
Of the 124,136 PROMs entries linked to primary hip
operations in the NJR, 99.7% of questionnaires were
completed pre-operatively but only 75.6% postoperatively. For hip replacement surgery 85.6% of
patients described themselves as being much better
compared to before the operation, 10% reported
having had a wound problem, 5.8% bleeding since the
operation, 7.3% recorded they had been re-admitted
to hospital since the operation and 2.1 % declared they
had had further surgery following the original operation.
In relation to change in EO-5D, the median change
following surgery was 0.380 (IQR 0.175 to 0.694)
and for the patients treated with a cemented metal-
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
on-polyethylene hip replacement the median change
was 0.413 (0.159 to 0.694) and this compared to
metal-on-metal resurfacing where the median change
was 0.309 (0.165 to 0.484). However, the median preoperative score for resurfacing was higher (0.587) for
metal-on-metal compared to metal-on-polyethylene
cemented (0.293).
The overall median change in EQ-5D Health Scale
score (VAS) was 9 (IOR -2 to 20). This tended to be
lower for all cemented where the median was 6 (-5 to
20) compared to uncemented where the median was
10 (-1 to 22).
The median change in Oxford hip score was 21 (IQR
14 to 28) for all cases and the variation between
fixation types of bearings was very low.
For knee replacement surgery 70.8% of patients
described themselves as being much better compared
to how they were before the operation, 13.4%
described having had a wound problem, 7.9%
bleeding, 9.6% having been re-admitted and 3.3%
having further surgery.
The median change in EQ-5D Index for all knee
primaries (with scores at both time points) was 0.275
(IQR 0.069 to 0.568). The median change was lower
for pateiio-femoral replacement (0.105). The median
change in EQ-5D Healthscale score (VAS) was 3 (-7 to
15) for all cases but 0 for pateilo-femoral replacement
(-10 to 15). The median change in Oxford knee score
for all cases was 16 (9 to 22) but again was lower for
pateilo-femoral joints at 10 (4 to 18).
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DEMO-00085-00023
L'l.l The National Joint Registry
6.
The National Joint Registry for England, Wales and
Northern ii eland has collected hip and knee joint
replacement data since 2003 The NJR has recorded
data on ankle replacement surgeiy since April 2010
and from April 2012, data on shoulder and elbow
joint replacement surgery. Northern Ireland has neen
submitting data since February 2013. The NJR is
currently the largest register of its kind in the world,
with over 1.4 million recorded procedures.
In July 2012. the NJR Steering Committee, along with
invited stakeholders, held a one-day workshop to
define the key activities necessary to support those
aims and their relative priorities.
The NJR.'s purpose and aims are set out in its
strategic plan and are summarised below:
Support suppliers in the routine postmarket surveillance of implants and provide
information to clinicians, patients, hospital
management and the regulatory authorities
1/1'2 Manaqement and fundi! •H
The NJR is managed by the Healthcare Quality
Improvement Partnership (HQIP) under a contract with
NHS England as part of the delivery of the National
Clinical Audit and Patient Outcomes Programme
(NCAPOP). HQIP support the work of the NJR
Steering Committee and all its sub-committees. The
NJR Steering Committee, which met four times in
2012/13, is responsible for overseeing the strategic
direction and running of the NJR, Last year its status
changed from that of an advisory non-departmental
public body (ANDPB) to Departmental Expert
Committee. Its members are currently appointed by
the Department of Health (DH) Appointments Team
following a formal recruitment process and the current
list ot members and their declarations are listed
in Appendix 1. The Steering Committee has a lay
Chairman, Ms Laurel Powers-Freeling.
Mmramc. goals:
1.
2.
3
4.
5.
Moi ntor ii I rea1 time tl re outcomes achieved
by brand of prosthesis, hospital and surgeon.
and highlight where these fail below an
expected performance in order to allow prompt
investigation and to support follow-up action
Inform patients, clinicians, providers and
commissioners of healthcare, regulators
and implant suppliers of the outcomes
achieved m joint replacement surgery
Evidence variations in outcome achieved across
surgical practice in order to inform best practice
Enhance patient awareness of joint
replacement outcomes to better inform
patient choice and patients' quality ot
experience tl irougl i ei igagement witl i
patients and patient organisations
Support evidence-based purchasing of joint
replacement implants for healthcare providers
to support quality and cost effectiveness
There are currently si> sub-corn mi ttees winch support
the work of the NJR Steering Committee
Chairman, Mr Martyn Porter
Chairman, Mr Keith Tucker
Chairman, Professor Paul Gregg
Chairman, Professor Alex Macgregor
\
Chairman, Mr Peter Howard
Chairman, Professor Paul Gregg
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
In early 2013, to reflect its change in status,
the Steering Committee started a review of the
NJR's governance and committee structure and
composition. The outcomes of the review are included
in Section 1.3.2 below.
The NJR services are delivered under three
separate contracts:
* The NJR Centre, managed and staffed by
Northgate Information Solutions (UK) Ltd.
Northgate is responsible for the management
and development of the NJR's IT infrastructure,
software applications, data management and
reporting services. This work is complemented by
the NJR Service Desk, a team who provide dayto-day information and support to stakeholders,
and the NJR Regional Coordinators (RC), an
eight-strong team providing on-site support to
orthopaedic units in hospitals.
* The NJR statistical support, analysis and research
team, based at the University of Bristol. The team
is responsible for the delivery of statistical analyses
of NJR data and data from other sources, and for
developing the statistical methodologies for the
identification of potential outlier performance.
Their role also includes ad hoc data analyses,
in addition to those included in the NJR Annual
Report, that are central to the work of the Implant
Performance Group and the Surgeon Outliers
Sub-committee.
1.1.3 Content of the 10th
Annual Report
The format of this report is similar to the 9th
Annual Report:
» Pom Co-?.- is a general outline of the work of the
NJR for the financial year 1 April 2012 to 31 March
2013. In addition to summary statistics relating
to the NJR's key data quality indicators, this
section includes a summary of the major activities
undertaken by the NJR and individual reports on the
work of the sub-committees.
* Pom Two is a description of joint replacement activity
reported to the NJR as having been carried out in the
calendar year 1 January to 31 December 2012.
* FTP 'Throe provides an analysis of survivorship
of hip, knee and ankle replacement procedures
carried out between 1 April 2003 and 31 December
2012. Data from the Hospital Episodes Statistics
(HES) service, Patient Episode Database for
Wales (PEDW), and the English Patient Reported
Outcomes Measures (PROMs) programme are also
included in the analysis.
* FTP Foe;' provides a series of reports about
clinical activity and outcomes at both Trust and
unit level.
* NJR Communications, managed by HQIP. This
is a programme of stakeholder and multi-media
communication to support the delivery of the
strategic plan including the publication of the
Public and Patient Guide to the NJR Annual
Report. The HQIP communications team also
support the Editorial Board and Regional Clinical
Coordinators' Network.
Currently the NJR is funded through a levy raised
on the sale of hip, knee, ankle, elbow, and shoulder
implants. HQIP manages the levy payment collection
and holds the NJR budget on behalf of the Steering
Committee. The funding model is being reviewed and
is likely to change in financial year 2013/14.
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DEMO-00085-00026
1,2.2 Key indicators
Whilst NHS hospitals in England and Wales have
always been 'expected' to submit data to the NJR, it
has always been mandatory for independent sector
units in England and Wales since the registry started.
However, the Standard NHS Contract for Acute
Services was amended in April 2011 (Section 12.1.2)
and now states that all providers shall participate
in audits relevant to the service they provide within
NCAPOP, of which the NJR is part. The submission
of complete data to the NJR is, therefore, now
mandatory for all NHS Trusts and Foundation Trusts
within England. The Welsh Government has agreed
that the NJR is mandatory for all NHS Wales hospitals
and the Northern Ireland Health and Social Care Board
has written NJR data entry into NHS Trust contracts,
this includes all NHS-funded procedures.
Performance against the three indicators of data
quality (compliance, consent, and linkability) has
continued to improve year on year, although the
provision of continual support to orthopaedic units is
required to maintain and improve performance levels.
These figures are available throughout the year from
NJR StatsOnline on the NJR website.
Compliance
The compliance rate is the proportion of procedure
records submitted to the NJR compared with the
levy returns for the number of implants sold.! It is
impossible to establish a one to one link between
a single levy and the use of the implant and this
comparison is subject to a number of factors, such
as variation in the procurement cycle throughout the
year. It is often the case that more procedures are
reported than levies are collected, leading to a positive
(>100%) compliance rate, followed by periods where
there are more levies raised than procedures reported.
For individual NHS Trusts, compliance can also be
measured against data held in the Hospital Episodes
Statistics (HES) service and the Patient Episode
Database for Wales (PEDW) service, though there are
likely to be minor variations between the two because
of coding differences. This comparison does not
include privately funded procedures that take place in
the independent sector in England and Wales as this
data is not submitted to either HES or PEDW. The
overall compliance rate from 1 April 2003 to 31
March 2013 was 86.8%.
Consent
The consent rate compares the number of records
submitted where the patient has agreed to their
personal data being stored on the NJR database with
the number of procedures recorded on the NJR.2
It is a requirement in England, Wales, and Northern
Ireland that patients 'opt in' to have their personal
data held by the NJR. Patient details are essential for
linking patient procedures in order to monitor joint
replacement procedure outcomes and it follows that,
without high rates of patient consent, the NJR will not
achieve its goals. Patients are known to rarely decline
consent, and a number of units regularly achieve 100%
consent rates. Failures to record positive consent are
usually due to the lack of robust processes in hospitals
which ensure that the completed consent form is
available to the person entering the procedure details.
The consent rate for 2012/13 was 91.0%.
For compliance analysis only, the number of procedures excludes the following procedures: re-operations other than revision; stage 1 of
a 2-stage revision; excision arthroplasty; amputation; and conversion to arthrodesis. These are excluded becausethey dp not include the
implantation of a component attracting the levy.
Persona! information includes NHS number, surname, date of birth and postcode.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
The linkability rate compares the number of records
submitted with the patient's NHS number with the
number of procedures recorded on the NJR. The
NHS number is required to link all primary and revision
procedures relating to a single patient.3
The ability to link ail operations relating to a single
patient is vital in determining clinical outcomes.
Operations are linked using the patient's NHS number.
Low rates of linkability adversely affect the ability of the
NJR to monitor clinical and implant performance.
Where the NHS number is missing, tracing is attempted
using the NHS Demographics Batch Service. This relies
on the patient's name, date of birth and postcode being
correctly entered. The linkability rate for 2012/13
was 95.6%.
Figure 1.1
Compliance, Consent, and Linkability Rates from 2003 to 2013.
Source: Procedures entered into ine NJR 1 April 2003 to 31 Moron 2013 and ievv suomissions to NJR bv
implant suppliers.
100 "
Q.
""*
\.
-
"S*
80 -
.-*:..••• " .•• •""'
£
60 -
40 -
»•'"
20 n
Financial year
lisiisyyi umin^ ^ ^ ^
^ ^ ^
Instil lii^mtynti^ ttiiiii
Compliance
43.4
68.3
81.6
80.6
95.3
91.6
114.3
106.8
90.3
91.0
Consent
63.3
64.3
74.0
81.2
84.4
87.6
87.9
89.0
90.5
91.0
Linkability
57.2
59.6
69.6
78.0
91.8
94.7
95.3
95.8
96.0
95.6
.,,,::$,,,
Jnkability
— # - " Compliance
- # ™ Co nsent
NJR data Is submitted for NHS number tracing and the 'linkability' figure includes NHS numbers that were traced subsequent to the
operation details being submitted to the NJR.
^ D wwA'.njrcentr'e.,org.u!i
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DEMO-00085-00028
1,2.2 Operation totals
By 31 March 2013, 1,456,756 hip, knee, ankle, elbow,
and shoulder replacement procedures had been
reported to the NJR. There were 196,403 procedures
submitted in 2012/13.
Table 1.1 shows the total number of hip and knee
procedures, recorded on the NJR in England and
Wales each year from 2008/09 to 2012/13. As for the
previous five years, the number of knee replacement
procedures (98,288) exceeded the number of hip
replacement procedures (94,044) in 2012/13 (51%
and 49% as a proportion). Table 1.1 also records
ankle procedures from April 2010 and elbow and
shoulder procedures from April 2012. Northern
Ireland's joint replacement data is included from
February 2013.
Table 1.1 lota! joint replacement procedures entered into the NJR, 2008/09 to 2012
which tine procedure took place.
England hip
England knee
England shoulder
England elbow
England ankle
Wales hip
Wales kneeWales shoulder
Wales elbow
Wales ankle
Northern Ireland hip
Northern Ireland knee
Northern Ireland shoulder
Northern Ireland elbow
Northern Ireland ankle
recorded by country in
88,830
92,698
'6.971
2,881
345
-123
518
679
4,900
3,919
,001
1,533
5.141
5,651
1,611
,506
5.099
5,557
13 |
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10
06 .=
CO
70
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33
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070
DEMO-00085-00029
Operation types
Table 1.2 below shows the number of procedures
reported by type from. 1 April 2008 to 31 March 2013,
Primary operations make up 91.5% of all procedures
reported, whilst the proportion of revisions (less
shoulders and elbows) has increased by 0.6% to 9.3%
from 8.7% in 2011/12.
Table 1.2 Total joint replacement procedures entered, into the NJR, 2008/09 to 2012/13, recorded by
procedure type.
£K££fMiy&l
Hip primary
Hip revision
Hip rc-opcration'
Knee primary
Knee revision
Knoo re-oporation
Ankle primary
Ankle revision
Shoulder primary
Shoulder revision
Elbow primary
Elbow revision
»
H
l
P^lsgs&o
69,3d 2
70,268
76,927
78,105
82,837
7,327
8,2-15
9,117
9,911
i 1,207
76
82
37
1
0
77,020
78.561
85,272
86,637
91,632
'1,511
5,117
5,766
5,310
6,606
88
76
19
u
418
30
538
iiU
0
650
6/
2,666
330
267
91
Re-operation information was not collected on the first version of the Minimum Dataset (MD3v1) from 1 April 2003 to 31 March 2004. It
was included on MDSv2 from 1 April 2004 and removed from MDSvS which came into use on 1 December 2007. However, some units are
continuing to use MDSv2 which is why some re-operations continue to be reported. The figures are included for completeness only.
30
f ^
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DEMO-00085-00030
Procedures by provider type
There are four types of organisations in England
carrying out hip, knee, ankle, elbow, and shoulder joint
replacement surgery;
There are no NHS treatment centres or ISTCs in either
Wales or Northern Ireland and as the numbers for
Northern Ireland only cover a six week period, they are
grouped together as a provider.
Table 1.3 shows the proportion of procedures by type
of provider.
* NHS hospitals
« NHS treatment centres
* Independent sector hospitals
« Independent sector treatment centres (ISTCs)'
Table 1.3 Proportion of reported proc:
NHS hospitals
Independent hospitals
ISTCs
Northern Ireland
69.4%
71.6%
71.7%
70.8%
71.2'%
53,231
56,272
61.707
62,570
66.952
26.1 %
24.4%
24.3%
25.2%
25.5%
20.010
19,164
20,881
22,256
28,947
4.5%
4.0%
4.1 %
4.0%
3.3%
3,474
3.159
3,493
3,494
3,075
-
-
-
0.1%
-
70
Hi
Continued >
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DEMO-00085-00031
Table 1.3(continued:)
i^^^^^4titi^^^^felt44ti^^
NHS hospitals
Independent hospitals
82.6%
2.176
M.7%
439
2.5%
75
5
ISTCs
,9
Northern Ireland
NHS hospitals
Independent hospitals
0.2%:
94. 1 %
337
5.5%
20
0.3%
ISTCs
1
Northern Ireland
0.0%:
0
i-urther information is available on the NJR website under 'NJR 10th Annual Report'
39
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DEMO-00085-00032
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DEMO-GQ085-0G033
1.3.1 Introduction
This section highlights the work undertaken by the NJR;
Steering Committee and its sub-committees throughout
2012/13. The reports not only reflect the continually
increasing requirements placed on the NJR by its
numerous stakeholders but the commitment and efforts
of the NJR Steering Committee members who receive
no remuneration, other than travel and accommodation
expenses, for their considerable effort.
The membership of the NJR Steering Committee
and membership of and attendance at meetings for
all sub-committees for 2012/13 can be found online
(Appendix Four).
1.3.2 NJR Steering Committee
In July 2012, the NJR Steering Committee held a
workshop with invited stakeholders to examine how
the NJR governance and operating model should
evolve to remain fit for the future. The four key
components of the workshop were: agree the purpose
of the NJR over the next ten years; agree and prioritise
the activities needed to support the purpose; assess
the capabilities necessary to deliver the activities
and consider the committee structure necessary to
support the delivery of those activities.
Having agreed the mission statement included at
Section 1.1.1, the workshop agreed the
following priorities:
It is clear that, as the NJR has matured over its first
ten years, the NJR's governance structure and its
resources, designed for a simpler set of activities and
outputs, could not be sustained with an increasing
work load, a growing list of strategic priorities,
changes in the healthcare environment, greater
stakeholder expectations, and rapidly increasing
international interest and collaboration.
In order to ensure that appropriate focus on all areas of
business was maintained, decisions could be made in a
timely and efficient manner, representation included all
major stakeholders, resource capacity was appropriate
to the effort required, and that roles and responsibilities
were clearly defined, the following updates to the NJR's
operating model were considered:
* The creation of a new NJR Executive Committee to
provide strategic leadership and decision making in
a more effective manner, and tasking the Steering
Committee to handle operational matters
* The creation of a new medical advisory committee
*• The appointment of a new post of NJR Medical
Director
* Ensuring that the sub-committee structure is fit for
purpose and can deliver the objectives
» Ensuring that the relationship between committees
and activities is transparent
* Improving data quality
« Increasing committee capacity through the
recruitment of new members and the involvement
of NJR RCC Network in what has previously been
steering committee and sub-committee business
* Improving data access, data availability and
data linkage
-v Ensuring patient involvement in steering committee
and sub-committee business
* Supporting research - internal and external
* Supporting the NJR's standing committee
structure, by convening ad-hoc working groups to
work on specific issues and areas of concern of
NJR development, with clear direction, specified
outcomes, timelines and budgets
v
- Effective stakeholder communications and patient
and public engagement
* Extending the benefits of the NJR - new joints, new
geographical areas
* Greater international collaboration as the largest
arthroplasty register in the world
* Supporting cost effectiveness and value for money
* Outcomes reporting and identifying best and worst
practice and
* Providing a Vapid response' service - bespoke
reactive analysis of NJR data
* Ensuring that all committees and working
groups have clear terms of reference, an
agreed composition, and defined purposes and
responsibility, and that members have ciearly defined
roles and terms of office
The work to define and agree the final operating
model will continue in 2013/14 with the final operating
model being submitted to DH for its consideration and
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
endorsement. Once that has been achieved, the final
structure will reflect the interactions and relationships
between the various committees and will include
detailed terms of reference for the committees and
their members.
1 3 3 NJR Editorial Board - Mr Martyn
Porter, Chairman
The composition and role of the Editorial Board
remains unchanged from 2011/12. Its main role is
to ensure that the Annual Report is produced on
time, for wider distribution at the British Orthopaedic
Association (BOA) Congress in the autumn, and to
ensure that it is reviewed in detail and quality assured.
In 2013/14, to celebrate the 10th anniversary of the
NJR, there will be an independent event to launch the
report's findings.
The overall publication process is managed by HQIP.
Parts One and Two, focusing on annual progress
and clinical activity, are managed by the NJR Centre
(Northgate Information Solutions), particularly with the
help of Mike Swanson and Claire Newell. Part Three,
outcomes after joint replacement is produced by the
University of Bristol team, particularly with the help of
Professor Ashley Blom, Michele Smith and Linda Hunt
(statistical lead). Part Four, Trust- and unit-level activity
is a joint contribution from the NJR Centre and the
University of Bristol.
The Editorial Board meets five times a year and has
several teleconferences with a significant part of the
editorial work carried out by email. We meet shortly
after the BOA Congress to discuss the response to
the recently launched report, to consider feedback
and start planning for the next report publication.
We then have a teleconference in March to review
the progress of the previous year's special topics
and to plan the special topics for the coming year.
The meeting in April is to update the Editorial Board
regarding the production of the Annual Report and
consider the timelines and actions that need to be
taken. In May we meet to review the early outputs of
Parts One to Four and to consider the format, tables,
content and accuracy. There are then two further
review stages before we meet in early July to approve
the content before formal sign off at the July NJR
Steering Committee meeting.
The secondary roles of the Editorial Board include
identification of special topics and in-depth studies. It
is recognised that the timelines to produce the Annual
Report are often very tight and more detailed work
takes a longer period to obtain the necessary outputs.
Recent in-depth topics have included analysis of
resurfacing, metal-on-metal hip replacements and this
year includes a study of mortality. There are plans to
study infection and revision operations in more detail.
All these studies are planned and monitored through
the Research Sub-committee to prevent duplication,
overlap and inconsistency.
NJR Fellowship Programme
The first two NJR Fellows, Mr Simon Jameson and
Mr Paul Baker, who were appointed for one year,
have worked with the Editorial Board and published
a range of papers on aspects of both hip and knee
replacement in peer review journals. They have also
worked in collaboration with the University of Bristol
but more often with their local mentors and academic
supervisors in their places of routine clinical activity.
They have both been extremely motivated and both
presented and published their work which is listed
in the appendices. A further update on the NJR
Fellowship programme is included at 1.4.11.
Annual Report Development Strategy
it is important that the Editorial Board recognise the
changes necessary with emerging technology. We
have established a working group which will consider
greater emphasis to online and, where possible, real
time reporting and, possibly, a shorter hard copy of
the report. We are also considering more interactive
modes of obtaining information.
We are also considering holding a Research Day
where the outputs and publications from the NJR can
be presented and discussed in more detail.
Public and Patient Guide
In conjunction with the HQIP communications team
and, in particular, Rebecca Beaumont, the Editorial
Board oversees the production of the Public and
Patient Guide which was first launched in 2011. We
will continue to develop this important output and
the 2012 edition included important patient-friendly
developments (see 1.4.5).
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
BOA Congress
The Editorial Board also work with the British
Orthopaedic Association where they provide at least
one instructional session at the Annual Congress. In
2013/14, we will be fortunate to have three sessions
as part of the programme.
13,4 Implant. Performance Subcommittee - Mr Keith Tucker/ Chairman
The Implant Performance Sub-committee essentially
embraces two committees. The main committee
includes the members of the Scrutiny Group together
with representatives from the implant manufacturing
industry. The composition of the Scrutiny Group
includes representatives from the NJR Steering
Committee, the Medicines and Healthcare products
Regulatory Agency (MHRA), HQIP, Northgate
Information Solutions and the University of Bristol.
It is the Scrutiny Group's brief to analyse and assess
the confidential data that relates to implants that have
come under performance review (potential outliers).
A performance review can be triggered by verbal or
written communication, a paper or presentation at a
surgical meeting or a report from another joint registry.
Most commonly a review results from analysis of our
own data where the Patient Time Incidence Rate
(PTIR) has been found to be unacceptably high. The
PT1R is the revision rate per 100 observed years and
is calculated by the statistical team in Bristol from
the data prepared by Northgate. The PTIR for every
implant Is measured twice yearly.
We are reviewing our methodology at present but
essentially when an implant has a PTIR of twice the
group PTIR (Level 1) a report is filed with the MHRA.
When the PTIR is only 1.5 times the group PTIR, a
warning letter is sent to the company (Level 2). Over
the past year there have been too Level 1 reports and
fourteen Level 2 reports.
Since this committee has been in existence we have
picked up outlier performance which has involved
'mix and match'. This is where components of
a hip replacement are made by more than one
manufacturer. Examples include a stem being made
by Company A and the acetabular component by
Company B. There have not been any examples of
outlier performance when the articulation has been
'hard on soft' (such as a metal or ceramic head
articulating with a high density polyethylene cup or
liner) but there have been two Level 1 reports and nine
Level 2 reports for combinations which involve 'hard
on hard' (such as metal-on-metal).
We keep a close watch on some, usually relatively
new prostheses, where concern has been raised in
other countries. For example, during the past year,
there have been some concerns expressed by one
manufacturer with regard to a femoral component
which incorporates a modular neck - this was
showing up as an outlier in the Australian Registry. We
have looked carefully at all the NJR data for implants
with modular necks and compared this to use in
some other countries, but surgeons recorded on the
NJR have not made a lot of use of modular necks
prostheses in hip replacement.
Looking to the future, the committee feels it is time
that we turned our attention to revision prostheses.
The NJR has about 76,000 revisions logged into the
database. Anecdotally we know that some revision
procedures do better than others. The implants are
often (but not always) extremely expensive. There are
also issues about whether surgical experience and
volume have a part to play in outcomes. In our view, a
fully comprehensive assessment of these implants is
now due.
My thanks go to all the committee for their dedication
and hard work - it is one of the great strengths of
the NJR that it has the ability to monitor device
performance in this manner, to facilitate outlier device
investigation by both the regulator and manufacturers.
Thanks too must go to Melissa Wright (HQIP) for her
organisation and note keeping.
13,5 Surgeon Outliers Sub-committee
- Professor Paul Gregg, Chairman
The Outliers Sub-committee (surgical data) met
three times in 2012/13. The committee's role is to
ensure that, at the earliest stage, concerns about
potential outlier performance of units and surgeons is
highlighted and communicated to those concerned.
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It is important to emphasise that the identification
of a potential outlier surgeon does not mean that
a surgeon's performance is poor as many other
contributing factors may have influence, for example,
type of implant used, case-mix and incomplete
provision of data to the NJR. All of these factors
have been seen to contribute to potential outlier
performance in some cases.
In the case of surgeons known to have retired,
be on long-term sick leave, moved abroad or left the
Trust or Local Health Board, a letter would also be
sent to the CEO for notification.
The first Annual Clinical Reports to NHS Trusts, Local
Health Boards and independent providers were sent
out in September 2012 and the reports contained the
following data:
Future reports will be sent out in April/May each year
to coincide with the new financial year.
* Compliance rate as a percentage
* Consent rate as a percentage
For private units, letters are sent to the Group CEO
who would forward the letter to the appropriate
general manager.
Six months after the dissemination of the Annual
Clinical Reports, the data is scrutinised and if
additional potential outlier units or surgeons are
identified, the relevant CEO is informed six weeks after
notifying the surgeon.
* Linkability rate as a percentage
* A 'traffic light' system indicating their performance
against these indicators: green, amber, red
In addition:
* Unit mortality ratio (reported as Standardised
Mortality Ratio (SMR) with a 'traffic light' system)
* Unit revision rate for hips and knees (reported as
Standardised Revision Ratio (SRR) with a 'traffic
light' system)
* Individual surgeon (anonymised) revision rates for
hips and knees
In addition, the SRR's are shown on funnel plots for all
units and surgeons with individual funnel plots for all
hips, cemented hips, uncemented hips, resurfacing/
MoM hips, hybrid hips, all knee replacements,
cemented knee replacements, uncemented knee
replacements, unicondyiar knee replacements and
patello-femoral knee replacements.
In the event of a surgeon being identified as a 'potential
outlier' (SRR > 99.8% control limit), a letter is sent
to the surgeon six weeks before the Annua! Clinical
Report is sent, informing him/her of the situation and
enclosing the data upon which the potential outlying
status had been calcuiated. This is to allow the surgeon
opportunity to validate the data which the NJR holds for
them. Separate notification of the identity of a potential
outlying surgeon is made to the CEO at the time of
sending the Annual Clinical Report.
CEOs are asked to acknowledge receipt of the
report and, if there is no response after a second
communication, the Care Quality Commission (CQC
in England or NHS Wales) is informed. The latter has
only been necessary for two Trusts following the first
distribution of Annual Clinical Reports.
Two CQC representatives attended one of the subcommittee meetings in order for the NJR to share
with them our current approach to managing: potential
outlier units and surgeons. The CQC will continue to
work with the NJR to determine how our data can form
part of the CQC Quality Risk Profiles information and be
used in their hospital inspection process in England.
In some cases, surgeons had been identified as
potential outliers because of their use of specific
prostheses known to have poor results and which,
subsequently, have been removed from the market.
It had been agreed that three years after a prosthesis
has been removed from the market due to poor
results, those cases would be removed from the
database of all surgeons and their SRR re-calculated.
In the three years interim, funnel plots would, be shown
with the withdrawn prosthesis in and a plot with the
withdrawn prosthesis out.
The committee also noted for 2012/13 the difficulties
encountered in an audit of Trusts to seek further
clarification of the performance of the Pinnacle
acetabular cup when used with a metal liner. Despite
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a letter being sent to 13 Trusts in July 2012 by Sir
Bruce Keogh, NHS Medical Director, instructing them
to take part, only eight responded by March 2013 and
only four of those had completed the data collection.
The matter was escalated to the COC to follow up on
behalf of the NJR. The audit has now been completed
for 12 of the 13 units and a report on the outcomes
provided to the MHRA and NHS England.
After extensive discussions it has been agreed
that, to give greater clarity on the sub-types of joint
replacement, the next Annual Clinical Reports will
show separate funnel plots for units and surgeons
as follows:
Knees
«• All types of knee replacements together
* Total knee replacement cemented
*- Total knee replacement uncemented/hybrid
survivorship statistics, as part of NHS England's
transparency agenda.
Thanks are expressed to the members of the
committee for their time and contribution to this
important, but sometimes challenging, process.
The Chair wishes to extend particular thanks to the
significant amount of work undertaken by Mr Peter
Howard in connection with many of the analyses.
13.6 NJR Research Sub-committee Professor Alex MacGregor, Chairman
The Research Sub-committee's remit is to maximise
access to NJR for the wider research community
whilst upholding the quality of research based on NJR
data. The committee takes formal responsibility for the
release of data for research through an impartial and
objective protocol and has oversight of the use and
reporting of NJR data by research groups.
s- Unieondylar knee replacement
* Patello-femoral knee replacement
Hips
* All types of hip replacement together
* Total hip replacement cemented
* Total, hip replacement uncemented
* Hybrid and reverse hybrid total hip replacement
* Resurfacing and metal-on-metal total hip
replacement
It is important to remember that the success and
validity of this outlier process relies heavily on the
diligence of Trusts, Local Health Boards, independent
providers and surgeons entering all primary and
revision procedures. It is the surgeon's, independent
provider's, Local Health Board's and Trust's
responsibility to make sure that all cases are registered
and accurate. Participation in the NJR has been
mandatory since April 2011 for NHS hospitals and
since April 2003 for the independent sector. Surgeons
are advised to check regularly with the NJR Clinician
Feedback System to ensure the data held by NJR are
accurate. This will become increasingly important with
the impending publication of named surgeon implant
During the period 2012/13, the committee sanctioned
the release of data to six external research groups.
These included data released for analysis that will
inform the revised NICE guidance for total hip and
surface replacement. The committee received an
unprecedented number of expressions of interest for
future project work from both the UK and overseas,
some of which has been submitted for external
funding. We encourage any researcher planning
externally funded work with the NJR to discuss their
proposals in confidence with the NJR in advance of
submission. Full details of the NJR's research data
access policy and protocols, together with detailed
guidance notes for applicants, can be found at
www.njrcentre.org.uk.
The research profile of the NJR has continued to
expand over the last year, with over 40 presentations
to national and international scientific meetings. A
total of 18 scientific papers have been published
in peer reviewed literature for this reporting year,
based on work carried out by the NJR statistical
analysis team at the University of Bristol and by
academic groups working on data releases that were
sanctioned by the committee.
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Notable publications in this period include a British
Medical Journal (BMJ) paper outlining the most
extensive contemporary analysis of the costeffectiveness of cemented, cementless and hybrid
prostheses for total hip replacement. Also published
in the BMJ, an analysis using NJR-HES linked data
of cancer risk in the seven years after metal-on-metal
joint replacement provided the first registry based
evidence of the absence of increased cancer risk
following surgery. Findings published in the Lancet
showed an inferior implant survivorship for metal-onmetal resurfacing in women when compared to other
surgical options. This year also saw the first set of
analyses to include NJR data linked to PROMs.
A full list of publications related to NJR data is included
in Appendix Two. The redesigned research library
section of our website catalogues all NJR research
data releases with their progress reports, together with
links to all publications related to NJR data.
13.7 NJR Data Quality Group Professor Paul Gregg, Chairman
A Data Quality Sub-committee was established
in 2012 and met once during this reporting year
2012/13.
Although there has been a gradual and progressive
improvement in compliance, consent and linkability
since the start of the registry, there was still concern
about the compliance with the registration of both
primary and revision joint replacement by some
Trusts despite being made mandatory in April 2011.
The terms of reference were to explore methods of
improving data capture and quality.
It was decided to try and establish a named data
quality person for each provider who would be
responsible on an annual basis, for providing the
numbers of procedures performed to the NJR for
cross-checking and validation.
A letter was sent to provider CEOs explaining that, as
part of their compliance with the NJR, a data quality
process was being created and it was therefore being
requested that they provide the name and contact
details of their nominated data quality returns person.
An instruction sheet was sent with the letter outlining
what was required from the nominated person and
providing advice regarding any coding issues they
may come across. The NJR website would list each
provider's nominated person.
It is disappointing to report that only 55 responses
were received from 151 letters which were sent
to all Trusts in England, Welsh Local Health Boards,
and private sector groups. Chase letters were sent
to all CEOs of non-responding providers, with copies
to Medical Directors, and failure to respond will lead
to a third and final letter being sent to provider CEOs
to state that any data from their units that appeared
in the public domain would be un-validated as the
NJR had not received a named representative. A
list of providers that have not supplied a data
quality representative will appear in future NJR
Annual Reports.
In addition to the above, a data accuracy audit is
being planned across 2.0 orthopaedic units under the
direction of the Regional Clinical Coordinators (RCCs).
A sample set of 30 patients (15 hips, 15 knees with
5 of each set being revisions) will be studied in each
of the units. This study will look at the accuracy of
data entry onto the NJR Minimum Dataset (MDS)
form (comparing with notes, theatre logs etc.) and
accuracy of transcription from the NJR MDS form to
the database.
It should be recorded that three previous data
accuracy studies have shown encouraging results for
the accuracy of the main data fields,
I would like to thank the members of the sub-committee
for their contributions and the RCC Network for
undertaking the proposed audit of data accuracy.
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1.3,8 NJR Regional Clinical
Coordinators' (RCC) Network
- Mr Peter Howard, Chairman
As Chair of the Regional Clinical Co-ordinators
Network since 2007, I am aware of the significant
achievements this group has made in supporting the
raising of the profile of the NJR to fellow clinicians and
acting as the key link in communicating NJR activities
to hospital managers and other relevant hospital staff.
Working with our respective Regional Coordinators
this year, the Network has, as always, been keen
to understand the specific concerns of individual
hospitals in relation to their NJR responsibilities.
Although there continue to be issues with some
Trusts, there are clear improvements within this area.
The RCCs have been vital to understanding specific
issues regarding data quality by initiating unit-level
audits of NJR data. This work feeds into the strategic
actions of the Data Quality Group and will become an
ongoing function of the Network.
This year also saw a substantial review of the MDS.
The RCCs were able to input into the list of proposed
changes to the dataset and help create a priority
group of actions to be implemented into the relevant
NJR forms in the coming months.
Once again, the RCC Network has supported the
development of the Patient and Public Guide to
the Annual Report by ensuring key messages from
the main report are distilled accurately to enable
patients to be clear about the key outcomes of joint
replacement surgery.
As my time as Chair of the RCC Network comes to an
end, I would like to thank all of the surgeons who have
put themselves forward for this role and their individual
efforts in championing the NJR at a local level.
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This section provides a brief summary of the work and
activities undertaken by the NJR during 2012/13.
1.4.1 Geographic extension of the NJR
From February 2013, hospitals in Northern Ireland
started to submit data to the NJR. Some system
development was necessary to accommodate a
patient identifier different to the NHS number used
in NHS Trusts in England and Welsh Local Health
Boards. The Healthcare Number (HCN) allocated
to patients in Northern Ireland is retained and used
if those patients subsequently receive treatment in
either England or Wales. The NJR already has many
HCN numbers recorded for patients who have had
joint replacement surgery. This means that it will
be possible to get a more accurate assessment of
outcomes where patients may have had a primary
joint replacement procedure in Northern Ireland and
a subsequent revision in either England or Wales.
it is hoped that the benefits that the NJR brings for
patients, surgeons, and healthcare management will
be recognised by independent providers.
It is hoped that units in both the Isle of Man and Jersey
will start submitting data to the NJR in 2013/14.
1.4.2 Extension of the NJR: Elbows
and shoulders
From 1 April 2012, the NJR started to collect
data about elbow and shoulder joint replacement
procedures. The project was supported by the British
Elbow and Shoulder Society (BESS).
The NJR Steering Committee has also agreed to a
two-year pilot in which PROMs, using Oxford Shoulder
Scores, wil! be collected from patients who have
undergone a shoulder replacement procedure at
six months following surgery. Pre-operative Oxford
Shoulder Scores are collected as part of the primary
shoulder data set. The follow-up wil! be with NHSfunded patients only in England and Wales.
1.4.3 Beyond Compliance: 'Protecting
Patients, Supporting Innovation'
For a manufacturer to market a joint replacement in
Europe, the device must have been awarded a CE mark
(Conformite Europeene). CE marks are categorised
according to the perceived risk inherent in the device.
Until 2008 joint replacement implants were graded as
Class 2b. Total hip, knee, and shoulder replacement
have since been re-classified to Class 3. CE marks are
awarded by Notified Bodies. Each European State has
one or more Notified Body which is supervised by the
appropriate competent authority in each country, e.g.
the MHRA in the United Kingdom.
The CE Mark is "Compliance". It is illegal for anyone
to hinder the sale of a product with a CE mark. The
CE mark is, to a very considerable extent, awarded on
the basis of 'Equivalence/ Until now manufacturers
have sometimes claimed equivalence in more than two
features of the design. Equivalence could have been
claimed in the material, shape, lubrication system etc.,
whilst at the same time claiming the product is a new
and important addition to the market. To obtain a Class
3 CE Mark, the manufacturer has also to outline a
post-market surveillance plan. Despite CE regulations,
devices have been introduced into the market that have
proven to be poor. Even with NJR, ODEP, MHRA and
the CE Mark, there are examples of implants falling
short of expectations. This has frustrated many for a
considerable period.
Mr Peter Kay, during his time in office as BOA
President, developed the concept of Beyond
Compliance, implicit in Beyond Compliance is the
invitation to a manufacturer to go beyond the demands
of the CE mark and enter into a process that will offer
greater rigour and organisation than that currently
available through the CE process. It is proposed that
Beyond Compliance, whilst remaining an entirely
voluntary process, could be used with all new implants
and modifications to established devices.
Beyond Compliance embraces two main features
and is governed by a Steering Committee. The first
feature is an Advisory Group service and the second,
a very sophisticated post-CE mark online surveiiiance
service. ODEP has been asked to take the lead with
Beyond Compliance and the panel agreed to set up
the advisory service and the monitoring process last
year at the invitation of the BOA and MHRA. NHS
Supply Chain is responsible for the administrative
organisation of the process.
The Advisory Group's first duty is to look at the detailed
product file provided by the manufacturer. The Advisory
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Group will then assess the level of residual risk there
might be with this product. The manufacturer's postmarketing surveillance plan, including post-market
clinical follow-up studies, will also be reviewed. With the
manufacturer, the group will discuss and agree the rate
at which the device could enter the market and add any
other comments they think appropriate. Following that
decision there will also be agreement on a plan for postmarket clinical follow-up, which will be monitored with the
implanting surgeons and manufacturer representatives.
Any implant selected for the process is notified to
the NJR Centre which will then create a record for
the implant in a central data repository. When the
record of a procedure is submitted to the NJR in the
normal way, the system will automatically recognise a
Beyond Compliance device and copy the procedure
details to that central repository. The repository will
also receive details of those procedures where the
device has been revised.
The NJR Centre will also be able to add procedure level
data from HES, PEDW, and the NHS England national
PROMs programme. Surgeons will be able to upload
additional data such as x-rays, operation notes and
video. Suppliers will also be able to upload pre-CE Mark
data and results from follow-up studies.
Not only will surgeons, suppliers, and Advisory Group
members be able to access all the data relating to
a specific implant, a number of automated reports
will also be available, enabling them to monitor the
performance of that implant. Additionally, there will
be a number of additional services, such as providing
suppliers with the ability to undertake follow-up studies
with patients. The flow of data and information is
shown in the figure below:
Figure 1,2
Beyond Compliance data flow,
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Should the results of a device going through
the Beyond Compliance process prove to be
unsatisfactory, the MHRA will be informed immediately.
Through this project, NJR data will be used to assist in
the monitoring of new devices with a view to detecting
problems earlier, if they occur, and to help promote
good practice with a system of sophisticated postmarket surveillance. Presently, with the involvement of
NJR, the development of this project is a world first.
Our progress to date has stimulated discussion for the
use of a Beyond Compliance system for other devices
such as breast implants and heart valves.
Please visit www.beyondcompliance.co.uk or contact
Mr Keith Tucker for further details.
It is appropriate to acknowledge the enthusiasm and
huge amount of preparatory work that Northgate
Information Solutions have put into this project.
1.4.4 Publication of
consultant-level data
In December 2012, the NHS England CEO, Sir
David Nicholson, announced plans for nine surgical
specialties and one medical specialty to start
publishing consultant-level activity and outcomes
information by June 2013. Orthopaedics was one of
the specialties included and the NJR will be used as
the source of outcomes data for hip and knee joint
replacement and will provide a web-based porta! for
the publication of this information. The NJR is working
closely with the lead specialty association British
Orthopaedic Association in their discussions with NHS
England and HQIP to ensure that the requirements are
understood and in order to obtain consent from those
consultant surgeons registered with the NJR to publish
their data. The data will be made available at
www.njrsurgeonhospitalprofile.org.uk.
1.4.5 Patient-focused initiatives
A second edition of the NJR's Public and Patient
Guide to the Annual Report was published in 2012/13
with notable improvements in content and design as
well as a choice of online formats - a standard PDF
or interactive version. These ideas and suggestions
were taken forward from the workshops at the
Patient Focus conference in 2012 and came to
fruition through the newly established NJR Patient
Network. The Public and Patient Guide has again
been awarded the Information Standard logo, a quality
mark for evidence-based information supported by the
Department of Health.
The NJR Patient Network has grown over the year,
meeting twice to share views and to get to know the
NJR and its work in more detail. Members have helped
to shape the recently revised patient information
leaflet and new poster for hospital waiting areas and
are currently involved in the development of a patient
implant card pilot project. The NJR would like to thank
all members for their thoughts, comments and time
spent contributing to the registry's progress.
The Network is a significant development for the
registry and the group will be a firm feature in the
NJR's structure and work programme in the future.
All of the registry's patient-focused initiatives continue
to be supported and championed at NJR Steering
Committee through patient representatives Mary
Cowern and Sue Musson.
1,4,6 NJR Feedback Services: Updates
NJR Clinician Feedback
The Steering Committee agreed to a project to
implement further reports in NJR Clinician Feedback
following the preparation of a set of prioritised
requirements by the RCC Network. These high level
requirements to be delivered are:
* A plot track for individual surgeons on the Patient
Time Incidence Rate report (PTIR) enabling
surgeons to identify either improving or worsening
outcomes. The PTIR report will also be able to
be run as 'Lead Surgeon' enabling either trainee
surgeons to assess outcomes where they were
the lead surgeon or enabling consultant surgeons
to separate those procedures where they were
the lead surgeon from those procedures where a
trainee was the lead surgeon.
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* The current Revision Rate reports will be updated
to include revision rates at five and seven years. As
for the PTIR report, the Revision Rate report will be
extended to include 'Lead Surgeon' in addition to
'Consultant in Charge'.
« Surgeons will be provided with further information
about their patients whose primary procedures have
been revised by another surgeon and, potentially,
in another hospital. The reasons for revision and
time to latest endpoint will be provided along with
sufficient information for the primary surgeon to
identify the patient and, if necessary, review patient
notes. Surgeons will also be able to download and
print the primary procedure details submitted to the
NJR for those patients.
* Surgeons will also be provided with an Annual
Summary report for the purposes of the revalidation
process, very similar to the Annual Clinical Report.
NJR Management Feedback
* NJR Management Feedback is used to produce
the Annual Clinical Report which was sent to units
for the first time in September 2012. The report is
available as a download from NJR Management
Feedback and is accessible by anyone in the unit
authorised to do so by senior management.
NJR Supplier Feedback
* NJR Supplier Feedback is a unique, procedurelevel online data reporting system to enable
manufacturers to perform post-marketing
surveillance on their range of implants.
Improvements to the Supplier Feedback system are
being considered to broaden reporting to revision
hips and knees as well as shoulder, elbow and ankle
joints. Linkage to PROMs data for primary hips and
knees is planned, along with the development of
additional online analysis tools.
1*4,7 Proposed changes to the
Minimum Dataset
reflect, for example, recent developments in chemical
thromboprophylaxis, the need to carry out different
types of analyses, removing inconsistencies between
the data forms, and the requirement to improve data
quality by removing ambiguity and changing system
defaults. The development will take place later in
2013/14 once the changes have been approved by
the NHS Information Standards Board.
1.4.8 Price Benchmarking
Quality, Innovation, Production, and Protection (QIPP)
is a large transformational programme for the NHS
which aims to improve the quality of care provided
by the NHS whilst, at the same time, making up to
£20 billion of efficiency savings by 2014/15 which will
be invested in frontline care. QIPP Procurement is a
workstream of the QIPP programme and aims to help
NHS provider Trusts reduce and optimise non-pay
expenditure without compromising quality of patient
treatment and care.
Orthopaedic joint replacement implants represent
relatively high cost and high volume procurement
within this category and are, therefore, subject to
particular focus. Orthopaedic implants are purchased
locally or regionally across England and Wales. Each
purchasing authority negotiates pricing with suppliers
based upon local conditions and purchase volumes.
As a result of this local procurement model, there are
variations in pricing for orthopaedic implants across
NHS England and NHS Wales. With funding from
the Department of Health, the Price Benchmarking
project aims to highlight this price variation in
England and Wales. Following a successful pilot in
2012/13 with three purchasing authorities, the pilot
project was widened to other authorities and will
continue to expand in 2013/14. Early indications are
that there are, in some instances, significant price
variations for some prostheses and that the volume
of purchases does not necessarily attract appropriate
discounts. This information will become more widely
available in the latter stages of the project roll out via
an online reporting tool.
The NJR Steering Committee has also approved the
development of the Minimum Dataset to the next
version, MDSv6. The changes are not major and
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1,4.9 International developments
The NJR is regularly approached and asked to take
part in a conference or symposium to support greater
international collaboration and we are keen to share our
experiences across the globe.
i n t e r n a t i o n a l Society of Arthroplasty
Registers (ISAR)
The NJR was certainly not the first joint registry. The
Scandinavians, in particular, were many years ahead
with Australia becoming an important member some
13 years ago. New Zealand was not long following and
there are now about 18 countries with national joint
registries in varying stages of development. The USA
has a relatively embryonic national registry but also has
a number of registries which tend to be regional. Italy
has three registries and a national registry project.
ISAR was set up in 2004 essentially between the
Scandinavian and Australian registries. The NJR joined
two years ago and are now full members. The idea
behind the foundation was to encourage registries to
communicate with each other and form data linkages we know that there is much to learn from each other.
ISAR had its first Congress in Bergen during May 2012
and, following its success, the management board
asked the NJR to host ISAR 2013 in the UK. It is a
great honour to showcase the NJR's progress and
developments, welcome a plethora of experience and,
of course, have access to Continuing Professional
Development (CPD) on one's own doorstep. The ISAR
working group chose Stratford-upon-Avon as the host
town, knowing it would produce an excellent ambience
for the meeting.
The current President of ISAR is Goran Gareliick and Mr
Martyn Porter will be President 2014/15 following the
American Academy of Orthopaedic Surgeons (AAOS)
meeting in February 2014.
I n t e r n a t i o n a l Consortium of Orthopaedic
Registries (ICOR)
The ICOR initiative was launched in 2011, essentially
as a response to the problems of metal-on-metal hip
replacement in the US. It was promoted by the US
Food and Drugs Administration (FDA) and launched
with an inaugural conference at their headquarters in
Silver Springs, Maryland. The meeting was attended by
representatives of most national joint registries. Since
then ICOR has promoted several collaborative audits
and reports. The NJR is represented on the ICOR
committee by Keith Tucker.
The US FDA and the European Commission are driving
the Unique Device identifier (UDI) initiative which the
NJR is fully supporting. Eventually all implants will have
a UDI (usually entrenched in their bar-code) which will
relate to an internationally agreed component database.
ICOR grant bursaries for research associated
with registry data and are willing to fund travelling
fellowships. For more information, contact Art
Sedrakyan whose details can be found on the ICOR
website (www.icor-initiative.org).
1,4.10 Patient Reported Outcomes
Measures (PROMs)
The NJR reported the results from its first PROMs
survey in the 2nd Annual Report in 2005. This study
was carried out in a group of 20,000 patients who
had previously undergone replacement of a hip or
knee joint. The NJR initiated a second more extensive
one year foliow-up PROMs programme in 2011.
In order to be eligible for the study, patients had to
have completed a pre-operative questionnaire for the
NHS England national PROMs programme and have
consented to have their personal details held by the
NJR. Over a six-month period, 50,000 questionnaires
were sent to patients, with approximately 42,500
being returned completed. With about 1,500
patients being lost to follow-up since the start of
the programme, approximately 41,000 Year Three
follow-up questionnaires will be despatched over a
six-month period which began in March 2013. It is
intended to undertake a further follow-up project at
five years following surgery.
The data from the Year One follow-up is currently
being examined and will be linked to both pre- and
post-operative data from the NHS England PROMs
programme, NJR data and HES data. The team
from the University of Bristol, along with Steering
Committee member Professor Alex MacGregor, will
undertake the analysis of the data.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
1.4.11 NJR Fellowships
* Evert Swab - Consultant orthopaedic surgeon,
North Bristol NHS Trust
Following the excellent work undertaken by the
previous two NJR Fellows, the NJR advertised the
availability of another Fellowship in the latter half of
2012. Following interview, Mr Jeya Palan has been
appointed and is due to start his Fellowship in April
2013. His work will be directed by the NJR Research
Sub-committee and he will be supported by the team
at the University of Bristol looking at issues in relation
to unicompartmental knee replacement in addition
to revision hip and knee replacements. Another NJR
Fellowship will be advertised later in 2013.
* lac Skwkwy - Consultant orthopaedic surgeon,
Sheffield Teaching Hospitals NHS Foundation Trust
The panel has recently started the assessment of
required criteria for the evaluation of knee implants
which will follow a similar process of data submission
and evaluation to the hip products. In order to gain
the expert knowledge required for this field we have
recruited the following members:
1.4.12 Orthopaedic Data Evaluation
Panel (ODER) overview
* RicKard Paridusan - Consultant orthopaedic
surgeon, Wirral University Teaching Hospital NHS
Foundation Trust
The ODEP group was set up to monitor NICE
guidance on primary hip implants in 2002 and hip
resurfacing in 2004. Although ODEP is independent
from the NJR, its Chairman Keith Tucker is also a
member of the NJR Steering Committee and the NJR
provides data to facilitate the monitoring process.
The NJR also uses ODEP outputs in a number of
published reports. The panel provides an ongoing
assessment of hip implants to benchmark both hip
femoral stems and hip acetabular cups against the
NICE guidance, providing a benchmark rating for
implant survivorship and submitted data quality. The
ODEP rating is now a commonly used benchmark
not only in the UK but globally. A full list of products
submitted to the panel and their individual ratings can
be found at
www.odep.org.uk.
* Aswww Rod:eca.-s •• Consultant orthopaedic
surgeon, North Bristol NHS Trust
The group is hosted by NHS Supply Chain and
members, listed below, volunteer their time
and expertise:
* HTTP; Tuskyr •• Chairman of ODEP - Consultant
orthopaedic surgeon from Norwich
* R«k-s Kay - Consultant orthopaedic surgeon,
Wrightington, Wigan and Leigh NHS Foundation
Trust.
« Philip Lewis ~ NHS Supply Chain
* ViarLe RAAford - Northgate, orthopaedic advisor to
the NJR
* CARo Rskw •• Consultant orthopaedic surgeon,
University Hospitals of Leicester NHS Trust
¥• A s d w w Toms •• Consultant orthopaedic surgeon,
Royal Devon and Exeter NHS Foundation Trust
* Timothy Wstco - Consultant orthopaedic surgeon,
Derby Hospitals NHS Foundation Trust
The panel members accept data submissions
for hips bi-annually in spring and autumn with
monthly meetings arranged to discuss and review
improvements to the process scheduled throughout
the year.
The year 2012 saw a marked increase in the level of
activity of the panel with the numbers of submissions
being provided for benchmark reaching 108 and the
start of three major activities:
* Initiation of a full review of the hip benchmarking
process
* Introduction of a benchmarking process for knees
* Formation of the Beyond Compliance Advisory
Group (see 1.4.3)
Plans for 2013/14 will see the full launch of the revised
hip process, submissions from industry to gain a knee
benchmark and the completion of the pilot phase of the
Beyond Compliance initiative. In addition, improvements
to access of information with the launch of a new
website and, in recognition of the importance placed on
ODEP, introducing further programme support.
* Aodv Smailwoed - Procurement Wales
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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1,5.1 Income and expenditure
2012/13
The NJR is self financing, funded by a levy raised
on the sale of hip, knee, ankle, shoulder, and elbow
implants to NHS and independent healthcare
providers in England, Wales, and Northern Ireland
(the latter from February 2013). The rate of the levy
is recommended by the NJR Steering Committee for
approval by the Department of Health (DH), and is
subject to a Memorandum of Understanding between
the DH, Welsh Government, Health and Social Care
Board Northern Ireland, Independent Healthcare
Advisory Services and the Association of British
Healthcare Industries (ABHI) Orthopaedics Special
Interest Section.
The levy was set at £20.00 per joint from 1 Aprli
2012 to 31 March 2013. Levy income in 2012/13
was £3,292,579 (2011/12: £3,131,630). Expenditure
for the same period was £2,512,741 (2011/12:
£2,831,850).
Below are some of the 2012/13 costs associated with
the major NJR project areas.
£46,750 (total cost of project £116,950)
£14,950 (total cost of project £49,950)
£39,083 (total cost of project £146,750)
£70,500 (total cost of project £141,650)
£49,705 (total cost of project £49,705)
The NJR's financial results are included in the audited
accounts of HQIP (Healthcare Quality Improvement
Partnership) which manages the registry The full
audited accounts are available on HQIP's website
from September 2013 (www hqip org uk) and also
from the Charity Commission, and Companies House
Total expenditure for members' expenses during
2012/13 was £8,337 (2011/12: £26,069).
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A1.1 NJR Steering Committee - Composition
As a department expert committee, the composition of the N JRSC by category is:
*• Chairman
« Orthopaedic surgeons
* Patient representatives
* Implant manufacturer/supplier industry
* Public health/epidemiology
* NHS;organisation management
* Independent healthcare provider
* Practitioner with special interest in orthopaedic care who is a GP, nurse or allied
health professional (physiotherapist or occupational therapist)
A1.2 Membership from Aon! 2012
Members are appointed as posts become vacant.
SO
Laurel Powers-Preelii ig
Chairman (from April 2011)
Professor Paul Gregg
Vice Chairman
Acting Chairman (October 2009 to March 2011)
Orthopaedic Surgeon (from October 2002)
Mr Mick Bnrroff
Orthopaedic device industry (from October 2002)
Mary Cowern
Patient Representative. Patient group - Arthritis Care (from
October 2006)
Dr Jean-Jacques de Gorier
Independent healthcare sector (from October 2011)
Professor- Alex MaeGregor
Public health and epidemiology (from October 2002)
Sue Musson
Patient representative (from October 2011)
Carolyn Naisby
Practitioner with special interest in orthopaedics (from July 2006)
Mr Martyn Porter
Orthopaedic surgeon (from January 2003)
Dean Sleigh
Orthopaedic device industry (from April 2008. Resigned in
February 2013)
Mr Keith Tucker
Orthopaedic surgeon (from May 20070
Andrew Wood head
NHS Trust management (from January 2007}
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DEMO-00085-00050
Ai .3 Observers
The following have regularly attended NJR Steering Committee meetings as observers:
Mr Peter Howard
Chairman of ttie NJR Regional Clinical Coordinators' Network
Dr Crina Cacou
Senior Medical Device Specialist, MHRA
Andy Smaliwood
Procurement Wales
Elaine Young
National Development Lead, HQIP
Robin Burgess
Chief Executive, HQIP
Robin Rice
Welsh Government
AI .4 Members' declarations of Interest
Laurel Powers-Freeiing
No interests to deoiare
Professor Paul Gregg
Emeritus Consultant Orthopaedic Surgeon, James Cook University Hospital,
Middlesbrough, Professor of Orthopaedic Surgical Science, Orthopaedic
Advisor for Ramsay Healthcare
Mick Borroff
Chair, ABHf Orthopaedics Special Interest Section
Employed by DePuy International Ltd, manufacturer of orthopaedic prostheses
Mary Covvern
Wales Director for the UK charity Arthritis Care
Dr Jean-Jacques de Gorter
Director of Clinical Services, Spire Healthcare
Professor- Alex MacGregor
Professor of Genetic: Epidemiology. University of East Angfia
Consultant Rheumatoiogist, Norfolk and Norwich University Hospital NHS Trust
Sue Musson
Managing Director, Firecracker Projects Limited (supplying management
consultancy to NHS organisations)
Non-Executive Director, Bndgewater Community NHS Trust
Carolyn Naisby
Consultant Physiotherapist. City Hospitals Sunderland NHS Foundation Trust
Mr Martyn Porter
Consultant Orthopaedic Surgeon, Wrightlngton, Wigan and Leigh NHS Trust
(orthopaedic unit has received financial support from DePuy International for
clinical and RSA studies for Elite Plus femoral stem arid C-Stem), Has acted
as a consultant to DePuy international in relation to the development of a hip
femoral stem (C-Stern AMT) and received royalties on this trip stem
Mr Dean Sleigh
ABHI Council member, ABHI Orthopaedics Special Interest Section
Mr Keith Tucker
Consultant orthopaedic surgeon. Norwich
Royalties received from Johnson & Johnson Orthopaedics more than five
years ago for contribution to design of hip prostheses (all royalties paid into an
orthopaedic charity)
Andrew Woodhead
Head of Mergers and Acquisitions, NHS London (until 31 March 2012)
Managing Director - Andrew Woodhead Consulting Ltd (from Oct 2012)
Associate Consultant - Defoitte (from Oct 2012)
Associate Consultant - Venta (from Nov 2012)
Trustee - Guideposts Charity (from July 2013)
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
This appendix provides details of published analyses and data releases that have been sanctioned by the NJR
Research Sub-committee between April 2012 and March 2013. NJR data is available for research purposes
following approval by the NJR Research Sub-committee. Ror further details please visit the NJR website at
www. nj rcentre -Org.uk.
Published papers (April 2012 to March 2013)
Factors influencing Revision Risk Following 15,740 Single-Brand Hybrid Hip Arthroplasties" A Cohort
Study From a National Joint Registry
Jameson SS, Mason JM, Baker PN, Jettoo P, Deehan DJ, Reed MR.
J Arthroplasty. 2013 Mar 21. pii: 30883-5403(13)00108-3. doi: 10.1016/j.arth.2012.11.021.
Cemented, cementless and hybrid prostheses for tola! hip replacement: a cost-effectiveness analysis
Pennington M, Grieve R, Sekhon JS, Gregg PJ, Black N, van der Meulen JH.
BMJ. 2013 Feb 27;346:f1026. doi: 10.1136/bmj.f 1026.
Mid-term survival following primary hinged total knee replacement is good irrespective of the indication
for surgery
Baker P, Gritchley R, Gray A, Jameson S, Gregg P, Port A, Deehan D.
Knee Surg Sports Traumatol Arthrosc. 2012 Dec 1.4.
Mid-term equivalent survival of media! and lateral umcondylar knee replacement: an analysis of data
from a National Joint Registry
Baker PN, Jameson SS, Deehan DJ, Gregg PJ, Porter M, Tucker K.
J Bone Joint Surg Br. 2012 Dec;94(l2):164 1-8. doi: 10.1302/0301-620X.94B12.29416.
The design of the acetabular component and srt:e of the femoral head influence the risk of revision
following 34,721 single-brand cemented hip replacements: a retrospective cohort study of medium-term
data from a National Joint Registry
Jameson SS, Baker PN, Mason J, Gregg PJ. Brewster N, Deehan DJ, Reed MR.
J Bone Joint Surg Br. 2012 Dec;94(l2):1611-7. doi: 10.1302/0301 -620X.94B12.30040.
Failure rates ot metal-on-metai hip resurfacings: analysis of data from the National Jomt Registry for
England arid Wales
Smith AJ, Dieppe P, Howard PW, Blom AW; National Joint Registry for England and Wales.
Lancet. 2012 Nov 17;380(9855):1759-66. doi: 10.1016/30140-6736(12)60989-1.
Patient and implant survival following 4323 total hip replacements for acute femoral neck fracture: a
retrospective cohort study using National Joint Registry data
Jameson SS, Kyle J, Baker PN, Mason J, Deehan DJ, McMurtry IA, Reed MR.
J Bone Joint Surg Br. 2012 Nov;94(11):1557-66. doi: 10.1302/0301-620X.94B11.29689.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Revision following patello-femorai arthoplasty
Baker PN, Refaie R, Gregg P, Deehan D.
Knee Surg Sports Trailmatol Arthrosc. 2012 Oct;20(10):2047-53.
Revision tor unexplained pain following unicompartmental and total knee replacement
Baker PN, Petheram T, Avery PJ, Gregg PJ, Deehan DJ.
J Bone Joint Surg Am. 2012 Sep 5;94(17):e126.
The association between body mass index and the outcomes ot total knee arthroplasty
Baker P, Petheram T, Jameson S, Peed M, Gregg P, Deehan D.
JBoneJointSurgAm. 2012Aug 15;94(16):1501-8.
Reason for revision influences early pattent outcomes after aseptic knee revision
Baker P, Cowling P, Kurtz S, Jameson S, Gregg P, Deehan D.
Clin Orthop Relat Res. 2012 Aug;470(8):2244-52. dor. 10.1007/sl 1999-012-2278-7.
The effect erf surgical factors on early patient-reported outcome measures (PROMs) following total
knee replacement
Baker PN, Deehan DJ, Lees D, Jameson S, Avery PJ, Gregg PJ, Reed MR.
J Bone Joint Surg Br. 2012 Aug;94(8): 1058-66. doi: 10.1302/0301 -620X.94B8.28786.
The effect of aspirin and low molecular weight hepann on venous thromboembolism after knee
replacement: A non-randomised comparison using Maternal Joint Registry data
Jameson SS, Baker PN, Charman SC, Deehan DJ, Reed MR, Gregg PJ, van der Meulen JH.
J Bone Joint Surg Br. 2012 Jul;94(7):914-8.
Comparison erf patient-reported outcome measures following total and nnicondylar knee replacement
Baker PN, Petheram T, Jameson SS, Avery PJ, Reed MR, Gregg PJ, Deehan DJ.
J Bone Joint Surg Br.2012 Jul;94(7):919-27.
Patient Reported Outcome Measures after revision of the infected Total Knee Replacement: Do patients
prefer single or two-stage revision?
Baker P, Petheram TG, Kurtz S, Konttinen YT, Gregg P, Deehan D.
Knee Surg Sports Traumatol Arthrosc. 2012 June 13.
Independent predictors of revision following metal-on-metal hip resurfacing: A retrospective cohort study
using National j o i n ! Registry data
Jameson SS, Baker PN, Mason J, Porter ML, Deehan DJ, Reed MR.
J Bone Joint Surg Br. 2012 Jun;94(6):746-54.
Smith AJ, Dieppe P, Porter M, Blom AW; National Joint Registry of England and Wales.
BMJ. 2012 Apr 3;344:e2383. doi: 10.1136/bmj.e2383.
Total hip replacement for the treatment erf acuie femoral neck fractures: results from the National Joint
Registry of England and Wales at 3-5 years after surgeryStafford GH, Charman SC, Borroff MJ, Newell C, Tucker JK.
Ann R Coll Surg Engl. 2012 Apr;94(3):193-8. doi: 10.1308/003588412X13171221589720.
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DEMO-00085-00053
Approved requests for NJR data for research (April 2012 to March 2013)
Rate of venous Thromboembolism in total ankle arthroplasty
Zaidi R
Royal National Orthopaedic Hospital NHS Trust, Stanmore
February 201.3
Does the type of venous "thromboembolism (VIE) chemoprophylaxis influence the rate of revision for
infection following primary hip and knee replacement?
Baker P
Health Education North East
January 2013
Total hip replacement and surface replacement for the treatment of pain resulting from end stage arthritis
of the hip (Review of technology appraisal guidance 2 and 44)
ClarkeA
Warwick Medical School, University of Warwick
December 2012
Understanding failure in unicompartmental knee arthroplasty
Murray DW
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford
November 2012
Revision rates by prosthesis type: parametric survival analysis to inform a model of cost-effectiveness
Danielson V
Johnson •& Johnson Medical
November 2012
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DEMO-00085-00054
iqiand, Wates and No?
N a t i o n a l 3»frtt Registry
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The following information will also be available on; the NJR website:
1.
NJR 10th Annual Report
2.
NJR 10th Annual Report
Part One: Annual Progress 2012/13 - Welsh Language
3.
NJR 10th Annual Report
NJR Steering Committee and Sub-committee
composition and attendance 2012/13
4.
NJR 10th Annual Report
NJR Steering Committee Terms of Reference
5.
NJR 10th Annual Report
NJR Regional Clinical Coordinators' Terms of Reference
6.
NJR 10th Annual Report
Prostheses Data
7.
NJR 10th Annual Report
Tables and Figures
8.
NJR 10th Annual Report
Public and Patient Guide
Parts One, Two, Three and Four (annual progress 2012/13,
clinical activity 2012, implant survivorship 2003 to 2012,
and Trust- and unit-level activity and outcomes 2012)
www, nj rce n tre ,o rg „ uk
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National Joint Registry for FmgUnd, Warn
This section summarises the number of hip, knee and
ankle replacement procedures undertaken in England
and Wales between 1 January and 31 December 2012
and entered into the NJR by 28 February 2013. Details
of elbow and shoulder procedures submitted between 1
April and 31 December 2012 and submitted into the NJR
by 28 February 2013 are also included. The information is
summarised according to the type of hospital or treatment
centre, procedure type and patient characteristics.
2,1.1 Hospitals and treatment centres
participating in the NJR
A total of 413 orthopaedic units were open and of
these 398 (96%) submitted at least one hip, knee,
ankle, elbow or shoulder procedure to the NJR (Table
2.1). During the life of the NJR there has been a trend
showing a greater proportion of all hip replacements
being performed in larger centres. However, in 2012
the proportion of large volume centres has remained
constant but the percentage of medium sized centres
(200-299) has increased by 3% (Figure 2.1).
On average, 218 hip replacements and 235 knee
replacements were recorded per orthopaedic unit over
the year, although the numbers varied from 1 to 1,490
procedures for any one joint type. Compared with
previous years, there was a decrease in the number
of units performing more than 400 knee procedures
(Table 2.2) but a large increase in the number of units
performing 300-400 knee procedures. Most units
performing ankle procedures perform less than 5 in a
year but there are four units doing larger volumes.
The nine months of recording elbow and shoulder
replacements show that most units do less than 5
elbow procedures in nine months whereas more than
half the units do more than 5 shoulder procedures in
nine months.
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Table 2,1 Total number of hospitals and treatment centres in England and Wales able to participate in the NJR
and the proportion actually participating in 2012.
England
Wales
England
Wales
Table 2.2 Number of participating hospitals, according to number of procedures performed during 201;
Hospitals entering replacements
Hospitals entering primary replacements
Hospitals entering replacements
Hospitals entering primary replacements
Hospitals entering replacements
Hospitals entering primary replacements
Note: Elbow and Shoulder data for nine months only.
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Figure 2.1
Percentage of participating hospitals by number of procedures per annum, 2004 to 2012,
Hip procedures
Year
400+
300 - 399
200 - 299
100 - 199
50-99
27%
31%
29%
25%
23%
21 %
22%
23%
31 %
17%
18%
19%
28%
19%
20%)
15%
15%
13%
15%)
18%
12%>
17%
<50
Number of
hospitals
Total hip
procedures
399
391
394
395
400
398
396
66,703
74,878
78.183
78.918
81,623
84.892
86,488
15%
14%
18%)
392
53,306
63,948
27%
12%
Knee procedures
100%
80%
74
60%
40%)
20%
0%
Year
^
400+
300 - 399
200 - 299
29%
100 - 199
50 - 99
24%
20%)
25%)
19%)
i5U
Number of
hospitals
Total knee
procedures
32%
19%
22%
19%
15%
15%
393
391
398
389
390
393
48,937
64,042
66.207
78.106
82,477
84.148
14%,
12%
11 %
392
392
386
86,974
89,837
90,842
13%
L njrcentre.org, ok
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The total number of hip procedures entered into the
NJR during 2012 was 86,488, an increase of 7% over
2011. Of these, 76,448 were primary and 10,040 were
revision procedures. The revision 'burden' increased
on the 2011 levels by 1 % to 12%.
Table 2.3'shows' that 93% of patients at independent
hospitals and ISTCs were graded as fit and healthy
or with mild disease according to the ASA system,
compared with 78% at NHS units.
resurfacings has decreased again this year to 1 % of
all primary procedures. The percentage of resurfacing
procedures done in Independent hospitals (3%) is triple
that of NHS hospitals (1 %), as shown in Figure 2.2.
Independent units and ISTCs perform more cementiess
hip primary procedures than NHS hospitals.
At NHS hospitals, revision procedures account for
14% of all procedures. In comparison, the revision
burden at independent hospitals is 7%.
Nearly all procedures (94%) undertaken at ISTGs were
primary procedures. The percentage of primary hip
Table 2.3 Procedure details, accord! ig to type of provider for hip procedures
Primary total prosthetic replacement
using cement
Primary total prosthetic replacement not
using cement
Primary total prosthetic replacement not
classified elsewhere (e.g. hybrid)
Primary resurfacing arthroplasty of joint
'XI -i 'i
21,985
1 1,399
Hip single-stage revision
Hip stage one of two-stage revision
Hip stage two of two-stage revision
Hip excision arthroplasty
3,024
:
~ Bilaterals will only be counted as a bilateral if tney are entered under the same operation during data entry. If the two procedures are recorded under two
different operations they will be counted as two unilateral procedures. Therefore, the count of bilaterals is likely to be an uiicerestirnate.
/ mjixentr8.org, uk
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Figure 2.2
Primary hip procedures by type of providei 2012.
100%
80%
60%
40%
20%
0%
T 3 0/.
u u /u
Resurfacina
Number of
procedures
52,675
2.2.1 Primary total hip replacement
procedures (THR) 2012
Of the 76,448 primary hip replacement procedures
undertaken in 2012, 33% were cemented THRs, 43%
were cemenfless, 1 % were hip resurfacing procedures
and 2% were large head metal-on-metal (LHMoM)
THRs (Figure 2.3). For the first time the number of
operations for the current reporting year available
for this report is greater than the previous year.
Normally, this is not the case as not all procedures
performed in the reporting year are submitted in time
to be reported in the Annual Report. It is too soon to
tell whether this is due to an increase in activity, an
increase in compliance, more timely submissions or a
combination of these factors.
The ratio between cemented and cemenfless
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20.927
2,846
procedures has continued to change in 2012. In 2011,
there was a 5% difference and in 2012 this increased
to 10% more cemenfless procedures than cemented
procedures being carried out. There has been an
increase in the percentage of hybrid (standard and
reverse hybrid) procedures performed. There has
also been a significant decrease in the percentage
of resurfacing procedures and in procedures where
a large metal head is used with a resurfacing cup
(LHMoM). This decline is thought to have resulted
from the well publicised voluntary recall of one brand
of resurfacing device (ASR - DePuy) and ongoing
concerns regarding the safety of LHMoM procedures
as reflected in MHRA guidance and follow-up.
In 2012, 15% of hybrid procedures were reverse hybrid
(cemenfless stem, cemented socket) and 85% were
standard hybrid (cemented stem, cemenfless socket).
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103
DEMO-00085-00062
Figure 2,3
Type of primary hip replaeement procedures undertaken between 2005 and 2012.
60%
•°#«c Cement! ess
22%
25%
27%
.32%
37%
41%
41%
43%
Hybrid
12%
14%
14%
15%
15%
16%
18%
20%
Resurfacinq
9%
10%
9%
8%
6%
3%
2%
1%
«#™ Large head metalon-metal (>36mm)
3%
6%
7%
8%
6%
5%
3%
2%
Number of
procedures
56,454
59,967
67,321
70,559
70,908
73,006
75,460
76,448
2.2.1,1 Patient characteristics
Age and gender were included for those patients
who gave consent for their personal identifiers to be
entered into the NJR and where consent was 'Not
recorded' (a total of 96%). The average age was 67.4
years, 0.2 years more than last year. Approximately
60% of the patients were female (Table 2.5) which is
the same as 2011. On average, female patients were
older than male patients at the time of their primary hip
replacement (69.7 years and 67.2 years respectively,
Table 2.5). Patients undergoing a resurfacing
procedure were the youngest, at an average age of
53,4 years (Table 2.5). Seven times as many males
have a resurfacing procedure compared with females.
According to the ASA system, 15% of patients
undergoing a primary hip replacement in 2012: were
graded as fit and healthy prior to surgery, compared
with 37% in 2003, Figure 2.6 shows the changes in
ASA grade over ten years. Patient BMI6 has increased
over the past eight years from 27.4 to 28.7, as shown
in Figure 2.7. Females undergoing THR have a
consistently lower mean BMI than males; the converse
is the case for TKR (Figure 2.22). Figure 2.7 shows that
there has been an increase in the number of patients
with a BMI of between 30 and 39 and a decrease
in the number of patients with BMI between 20 and
24. The single, largest indication recorded for surgery
was osteoarthritis, recorded in 92% of procedures
(Table 2.4). Figure 2.5 shows that the percentage of
patients within the age group bands has not changed
BMI: 20-24 normal, 25-29 overweight, 30-39 obese, 40+ morbidly obese.
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104
DEMO-00085-00063
significantiy since 2003, suggesting that the increase in
BMI and reduction in fitness of patients is not due to an
ageing patient cohort. However, only 16% of entries in
2005 had BMI data entered (BMI was not collected as
part of MDSvl) and, while this has increased to 67%
in 2012, all BMI data has to be viewed with caution as
surgeons may be more likely to enter BMI data when
the BMI is high, introducing an element of bias.
Table 2.4 Patient characteristics for primary hip replacement procedures in 2012, according to procedure type.
PI -fit and healthy
P2 - mi id disease not
incapacitating
P3 - incapacitating
systemic disease
P4 and P5
10%
6, id5
18%
17,730 70%
23,800
70%
2/133
2,011
13%
1 1,061 70%
503 16%
11,002
15%
515 50%
53,109
70%
0 0%
3 <i%
10
67
<1%
<i%
1%
Number with BMI data
Average
SD
Osteoarthritis
Avascular necrosis
Fractured neck of femur
Congenital dislocation/
Dysplasia of the hip
I ntlammatory arth ropat hy
Faiiori hemiarthroplasty
Trauma - chronic
Previous surgery - non
trauma, relatec
Previous arthrodesis
Previous infection
Other
P I
Bilateral
Left, unilateral
Right, unilateral
^ D
^w * 1
42 <1%
11,273 45%
14,001 55%
228
15,487
18,428
<1%
45%
54%
17
288
<t%
2%
80
7,215
<1%
45%
8,612
54%
18
2%
1,071
14
1%
364
520 40%
34,504
45%
539 50%
41,580
54%
mi
<i%
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105
DEMO-00085-00064
Table 2.5 Age and gender for primary hip replacement patients in 2012.
Average
SD
Interquartile
range
<30 years
20
1 18
30 - 39 years
63
287
-10-'19 years
204
50 - 59 years
983
6%
< i %
30
<1%
3
38c
171
<1%
90.'
67
<1 %
8
/ 8v-
425
<1%
1,176
6%
306
3%
32
2784
1,718
4%
3,390
19%
1.001
10%
53
448c
5,427
12%
00 - 69 years
6,523
36%
2,838
29%
22
188c
13,160
3084
70 - 79 years
6,864
5,051
28%
3,561
3784
1
<1%
15,477
35%:
3.972
1,558
9%
1.729
18%
1
< 184
7,260
1684
279
73
<!%
150
2%
0
08c
502
80 - 89 years
90<30 years
30 - 39 years
40 - 49 years
50 - 59 years
60 - 69 years
70 - 79 years
80 - 89 years
90-
1%
liii
12
1 16 \\%
30
<1%
1 1
184
169
<\%
39
298
2%
61
1%
52
68-c
450
2%
182
1.146
8%
261
5%
220
26%
1,809
6%
21 %
761
1484
339
4084
4.708
1684
595
3,013
2,278
5.309
36%
1,708
3084
189
23%
9,484
32%
3,569
3.761
26%
2,001
3684
24
38c
9.355
3284
752
13%
3
<1 84
3,369
11%:
<r. 1 84
0
0%
161
<1%
1.638
95
42%
19%
1%
34
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106
DEMO-00085-00065
Table 2.6 Indications for hip primary procedure based o n age groups.
Osteoarthritis
Avascular
necrosis
Fractured
neck of
femur
Congenital
dislocation/
Dysplasia of
the hip
Inflammatory
arthropathy
Failed hemiarthroplasty
Trauma chronic
Previous
surgery,
non trauma
related
Previous
arthrodesis
Previous
infection
Indication
other
150
75 22%
3I
f:)%
2 <l
182 2 1 %
33
4%
10
i%
338
9%
i(X)
3%
7 <l%
12
4%
26
30c
81
2%
23
7%
41
5%
58
2%
5
1%
1 <1%
4
,• 1 C.'
--. 1 ,'U
8
2%
10
1%
M 12%
63
~%
7 <1%
128
4%
27;
161
3%
2%
20 < 1 %
148
1%
46 < 1 %
312
1%
43 <. 1 %
236
1%
14c
94 < i %
67 <1 %
16 < 1 %
219
226 <1 %
6 <1%
9 <1%
14 < t %
1%
175
0
0%
0
0%
2%
27 < t %
5 <1%
146
1 --:1%
(58 <1%
248
1%
4 <l%
142
1%
^
D wwA'.njrcentr'&,org.u!i
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DEMO-00085-00066
Figure 2,4
Age and gender for primary hip replacement patients in 2012.
Female
100%
Male
100%
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DEMO-00085-00067
Figure 2.5'
Age for primary hip leplaoement patients between 2003 and 2012.
100%
<D -Q
OS oj
Q.
*^O_ <a
<•>)
<i>
U)
m
<a
sz
O
<C
C)1 <JJ
o
(I)
Q.
30-39
40-49
50-59
60-69
70-79
80-89
90+
1%
4%
16%
31%
33%
13%
<1%
1%
5%
15%
31%
33%
13%
<1 %
1%
1%
1%
5%
1%
5%
1%
5%
16%
31%
34^
13%
<1%
15%
30%
34%
13%
:1%
15%
31%
34%
13%
<1%
15%
30%
34%
13%
<1%
14%
30%
34%
14%
'1%
1%
1%
1%
5%
14%
30%
34%
14%>
<1%
14%
31 %
34%
14%
<1 %
14%
31%
34%
14%
<1 %
>%
Number of
14,557 28,222 40,370 47,687 60,637 66,892 67,729 69,900 72,537 73,645
patients
^ D
^w ^
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109
DEMO-00085-00068
Figure 2.6
ASA grades for primary hip replacement patients between 2 0 0 3 a n d 2 0 1 ;
HI—Wl—HUT
o.
b
as
en
P2
53%
57%
60%
63=
66%
70%
70%
69%
69%
69%
P3
9%
3%
11%
13%
13%
13=
14%
15%
15%
15%
P4 and P5
:1%
:1%
<1%
<1 %
:1%
<1%
;1%
:1%
<1 %
:1%
Number of 26.435
48,061 57,594 59,967 67.322 70,559 70,908 73,006 75.461 76,448
patients
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110
DEMO-00085-00069
Figure 2,7
BMI for primary hip: replacement patients between 2004 and 2012.
30
*
Average BMI
- all patients
60%
27.36
27.47
27.67
27.91
28.31
28.43
28.53
28.60
28.71
BMI 15-19
3%
3%
3%;
3%
2%-
>%
2%
2%
2%
BMI 20-24
27%
27%
25%
24%
21%
21 %
20%
20%
19%
BMI 25-29
40%
40%
40%
40%
41%
40%
40%
40%
40%
BMI 30-34
21%
21%
21%
23%
25%
25%
25%
26%
26%
BMI 35-39
6%
6%
7%
3%
3%
9%
9%
9%
10%
BMI 40-44
2%
2%
2%
2%
2%
2%
2%
2%
3%
BMI 45+
<1%
<1 %
<1 %
<1%
<1%
<1%
<1%
<1%
<1%
*
Average BMI
- female
27.29
27.15
27.53
27.77
28.12
28.22
28.31
28.40
28.49
*
Average BMI
- male
27.71
27.87
27.94
28.16
28.62
28.72
28.83
28.92
29.04
Percentage of
procedures
with BMI
17%
16%
18%
21%
48%
56%
60%
64%
67%
Number of
procedures
with BMI
5,919
9,002
10,473
14,237
33,842
39,431
43,679
48.345
51,300
2.2.1.2 Surgical techniques
The surgical techniques used in procedures in 2012
are summarised in Table 2.7. Patients were mainly
positioned laterally. The lateral position was used more
frequently in hybrid and resurfacing procedures than in
cemented and cementless procedures. As would be
expected, the most frequently used incision approach
was posterior for all procedure types, though for
cemented procedure types there were nearly as
many procedures performed where a lateral (including
Hardinge) approach was used.
The reduction in the use of cemented stems (from
77% in 2004 to 51 % in 2012) and also in the use of
cemented cups (from 56% to 36%) is consistent with
the reduction seen in the overall number of cemented
procedures and a corresponding increase in hybrid
and cementless surgery. The change in 2012 appears
to have been mainly caused by the rapid decline
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111
DEMO-00085-00070
in metal-on-metal procedures rather than a switch
from one type of conventional hip replacement to
another since 2004 (Figure 2.3). The relative usage
of different types of bone cement is shown in Figure
2.8 and shows that the use of antibiotic cement has
increased from 73% in 2004 to 89% in 2012. Use of
minimally-invasive surgery was greatest in cementless
procedures, although it was used in less than 5% of all
procedures (Table 2.7) which is the same as 2011.
Table 2.7 Surgical technique for primary flip replacement patients in 2012.
1,014
24,302
4%
96%
1,321
32.822
4%
96%
841
15,066
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DEMO-00085-00071
hgure > ,©
Bone cement types for primary hip replacement procedures undertaken between 20.04 and 2012.
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
U kJ IiJ ItJ lii i J
Antibiotic-loaded
medium viscosity
6%
7%
8%
9%
9%
10%
10%
9%
9%
Antibiotic-loaded
low viscosity
5%
4%
3%
3%
3%
2%
2%
1%
1%
6%
6%
5%
5%
5%
4%
3%
2%
19%
<1%
17%
<1 %
18%
<1 %
17%
<1 %
15%
<T%
13%
<:1 %
11%
<1%
9%
<1%
8%
:1%
34.497
40,473
40,544
44,334
43,362
41,514
41.108
43,359
43,789
High viscosity
Medium viscosity
Low viscosity
Number ot
procedures
using cement
2.2.1.3 ThromboprophyLaxis
Patients may receive more than one chemical and more
than one mechanical thromboprophylaxis method.
The most frequently prescribed chemical method of
thromboprophylaxis for hip replacement patients was
low molecular weight Heparin (LMWH), at 73%, and
the most used mechanical method was TED stockings
^ D
^w * 1
(66%), (Table 2.8). There has been a marked decrease
over the past years in the use of aspirin, 20% in 2009
to 8% in 2012. Direct thrombin inhibitor is now used
in 13% of hip primary procedures and the use of
'other chemical' has gone up from 7% in 2009 to 13%
in 2012. The number of procedures for which both
chemical and mechanical methods were prescribed has
continued to rise from 63% in 2007 to 92% in 2012.
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DEMO-00085-00072
TaKla-O 0 T h r
^ e A r i h f l H cts+ t i r r i o /-^t / - s r v o r o t i / ^ r
i f i i n t r\C3+i^r\to
Aspirin.
Pentasaccharide
xlsilifjiillllllll::
Direct thrombin inhibitor
No chemical
lllpdlpdmill
Intermittent calf compression
6,124
8%
11:111::
1111
1,148
2%
illllli:
:ili:;:
10,203
13%
liill:;
isli:
2,143
riiiii
ill:;:
3%
33,052
43%
rllll
lllll;:
Other mechanical
:;:i^p:iraMiii0ieiai;:;:;:;:;:;:;
Both mechanical and chemical
fNiifhebm^^
2,272
3%
iill:;
mm
70,700
92%
111;:$$;
Hill
As would be expected, this occurred more often in
cementless than in cemented hips. Furthermore,
16% were trochanteric fractures, also more common
in cementless procedures. 36% of events were of
'other' description.
2.2.1.4 Untoward intra-operative events
Untoward intra-operative events were reported in
1.3% of procedures (Table 2.9). Of the 999 untoward
events reported, a decrease of 9 events compared
with 2011, 33% were attributed to calcar crack.
Table 2.9 Reported untoward intra-operative events for primary hip replacement patients in 2012, according to
procedure type.
IPalyiclphsffafidn::;
Shaft fracture
:;;§ibiil$
Trochanteric fracture
Irilerllllllllllllll
:i!
Hi
§1
13
22
11
46
;:;:;#$;
56
61
39
111:
Hi
ii
ill
156
fill::
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114
DEMO-00085-00073
2,2,1.5 Hip primary components
This section outlines in more detail the trends in
brand usage for hips. For a full listing of brands used
in 2012, please visit the NJR website at
www.njrcentre.org.uk. This section also includes an
analysis of usage according to National Institute for
Health and Care Excellence (NICE) guidelines, as
interpreted by the Orthopaedic Data Evaluation
Panel (ODER).
2.2.1,5.1 Compliance with ODEP and
NICE guidelines
nor the ODEP process, The latest listings for brands
currently being used in England and Wales can be
seen on the ODEP website:
www.odep.org.uk
Analysis of primary procedures shows that the use of
products meeting the full 10 year (1..0A) benchmark, as
recommended by NICE, is as follows:
* Cemented stems 88% (using 14 brands out of 47
recorded on the NJR)
* Cementless stems 69% (17 brands out of 91)
* Cemented cups 34% (10 brands Out of 43)
In 2012, 101 brands of acetabular cup, 8 brands of
resurfacing cup and 146 brands of femoral stem were
used in primary and revision procedures and recorded
on the NJR. This is a decrease in the number of
brands of acetabular cup and stem in use compared
with 2011.
The 2nd NJR Annual Report in 20047 gave a full
description of the NICE guidance on the selection
of prostheses for primary THRs and metal -on- metai
hip resurfacing arthroplasty. It also described the
establishment of ODEP. Its remit is to provide an
independent assessment of clinical evidence, submitted
by suppliers, on the compliance of their implants for
THR and hip resurfacing against NICE benchmarks
for safety and effectiveness, ODEP produced detailed
criteria for this guidance which is currently under review
as part of a complete overhaul of the system,
The ODEP committee have reviewed suppliers' clinical
data submissions and ODEP ratings have been given
to 69 brands of femoral stem (50% of those available)
and 49 brands of acetabular cup (49%) used in
primary procedures. However, there are 39 brands of
acetabular cup (39%) and 46 brands of femoral stem
(33%) currently being used in England and Wales for
which no data has yet been submitted to ODEP. It
should be noted however that some of this usage
relates to stems designed for revision surgery being
used in primary procedures for unspecified reasons.
Revision brands are not covered by NICE guidance
7
* Cementless cups 3% (7 brands out of 57)
* Resurfacing cups 63% (1 brand out of 9)
These percentages are based on the latest ODEP
ratings from clinical outcomes data already submitted to
the ODEP committee and published in February 2013.
Manufacturers are expected to submit additional data
to progress through the ratings and this will result in
these percentages changing in the future.
Comparison with the 2011 figures shows that use of
cemented and cementless sterns achieving the 10year benchmark has not changed significantly. Usage
of cementless stems achieving the 10-year benchmark
is 69% (a decrease of 3% on last year). However, the
percentage for cementless cups achieving 10-year
benchmark was 3%.
2.2.1.5.2 Hip brand usage in
primary procedures
Figures 2.9 to 2.13 show historical trends in the usage
Of the most popular brands of cemented stems,
cemented cups, cementiess stems, cementless cups
and hip resurfacing cups.
Figure 2.9 shows that the market is dominated by
polished eollariess tapered sterns, with the Exeter
V40 having a market share of more than 66% and
the CPT stem continuing to consolidate its position in
second place.
See pages 86 to 92 of the 2nd NJR Annual Report, available on the NJR website www.njrcentre.org.uk,
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Figure 2M
Top five, cemented hip. stem brands, trends 2003 to 201.2.
70%
Exeter
V40
•#-••• CPT
C-Stem AMT
Cemented Stem
The trend for cemented cups (Figure 2.10) continues
to show that sales of different brands are in line with
the popularity of the stem manufacturer. The only
C-Stem
Cemented Stem
..%.... Charnley
^
Cemented Stem
significant change being a proportion of Exeter stem
users switching from the Contemporary to the Exeter
R'imfit cup, both manufactured by Stryker.
r ; „ , s „ vs o -in
Top five cemented hip cup brands, trends 2003 to 2012.
40%
—#— Contemporary
™%-
Elite Plus
Ogee
™#™ Exeter Rimfit
~#~ Marathon
Elite Plus
Cemented Cup
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DEMO-00085-00075
The relative sales of cementless stem brands (Figure
2.11) are very similar to the previous year, with pressfit HA coated stems continuing to dominate the
market. The Corail prosthesis continues to maintain its
position as market leader.
Figure 2.11
Top five cementless hip stem brands, trends 2003 to 2012.
50%
I™ Corail
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~<ssw Furlong
*
HAG Stem
Accolade
™#™ Taperloc
Cementless Stem
M/L Taper
Cementless
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DEMO-00085-00076
The cernentless stem market share has again reflected
the sales of the corresponding cernentless cups
from the same manufacturers, which means that the
Pinnacle cup from DePuy has retained its position
as the market leader (Figure 2.12) despite appearing
to lose some share to other brands, notabiv the
f™0-«- sv.-\ o
Exceed AST from Biomet. More information on the
other brands used can be found in the document
'Prostheses used in hip, knee, ankle, elbow and
shoulder replacement procedures 2012' which can be
downloaded from the NJR website.
~s *~&
Top five cernentless hip cup brands, trends 2003 to 2012.
HU70
35% -
.„.„
-»~~^
30% 25% 20% 15% 10% 5% -
0% -I1
~ # ™ Pinnacle
•*>
---#•--- Trident
Exceed ABT
Trilogy
™#™ CSF Plus
w
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118
DEMO-00085-00077
2012, at the expense of ail other brands reflecting its
clinical performance when measured against most of
its competitors. However, it should be noted that this
is against a background of an ongoing decline in the
overall volume of resurfacing hip replacement.
Figure 2.13 shows the sales evolution of brands of
hip resurfacing prostheses in the English and Welsh
markets. It is evident that the previous trend towards
a decline in the usage of the original brands has
continued to reverse. The market share of the BHR
brand increased significantly during the course of
higure 2.13
Top five resurfacing head brands, trends 2003 to 2012.
90%
80% 70%
60%
>-~
50%
...—*--'"
40%
30%
20%
10%
0%
2 640
BHR
•"#— Resurfacing
Head
5 031
Adept
Resurfacing
Head
6 230
6,502
6 701
Cormet 2000
Resurfacing
Head
5,798
4 358
2,689
Accis
Resurfacing
Head
1883
1,075
Recap
Resurfacing
Head
2.2.1,5,3 Trends in head size use
2.2,1,5,4 Trends in hip articulation
Figure 2.14 shows the relative usage of different
femoral head sizes (for all femora! heads used in
conjunction with a femoral stem) each year since the
inception of the NJR. it is immediately clear that there
has been a gradual increase in the use of larger head
sizes (36mm diameter and above). However, between
2010 and 2012 this had been reversed slightly.
This trend accurately reflects the trends in usage of
LHMoM prostheses during the lifetime of the NJR.
Figure 2.15 shows the change in hip articulation types
since the inception of the NJR. Only those procedures
where complete articulation surfaces can be derived
are included. The most interesting observation being
the huge rise in the use of ceramic-on-ceramic
bearings, from small numbers in 2003 to over 17,000
in 2012, though this has remained steady over the
past year, This growth would appear to have been
mainly at the expense of metal-on-metal bearings.
^ D
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119
DEMO-00085-00078
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CD
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o
o
o
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CD
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3
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o
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Percentage of procedures
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2,2,2 Hip revision procedures 2012
A total of 10,040 hip revision procedures were
reported in 2012, an increase of 1,401 compared
with 2011. Table 2.10 shows that of these, 8,812
(88%) were single-stage revision procedures, 560
(6%) were stage one of a two-stage process, 611
(6%) procedures were stage two of a two-stage
revision and 57 (<1%) were excision arthroplasty
procedures. Infection as an indication for revision has
increased to 12% of the total.
2.2.2.1 Patient characteristics
(with the exception of excision arthroplasty). However,
the percentage of patients who were graded as being
fit and healthy prior to surgery has decreased from
26% in 2003 to 10% in 2012.
Aseptic loosening has continued its decrease as a
reason for revision compared with previous years.
Adverse soft tissue reaction was noted for 13% of
ali revision procedures (Table 2.10). However, this
option was added in July 2009 so it is not possible
to tell if this increase is actual or due to a delay in the
usage of the new MDS H2 data forms. More than one
indication for revision may be given.
Table 2.10 summarises patient characteristics for the
10,040 hip revision procedures undertaken in 2012.
Compared with 2011, the patient demographics have
iargely remained unchanged, though there was a slight
increase in the average age in each procedure type
JEWELL 12.1
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DEMO-00085-00080
Table 2,10 Patient characteristics for hip revision procedures in 2 0 1 2 , according to procedure type.
fit and healthy
P2 - mild disease not
incapacitating
P3 - incapacitating systemic
069
] 0%
6,316 63%
Lysis
Pain
Dislocation/subluxation
Poriprosthetic fracture
Infection
Malalignment
Fractured acetabtriiim
Fractured stem
Fractured femoral head
Incorrect sizing head/socket
Wear of acetabular
component
Dissociation of liner
Adverse soft tissue reaction
Other
199
12%
158
2%
1,330
13%
899
9%
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Table 2.11 Indication for surgery for hip revision procedures 2008 to 2011
Aseptic loosening
Pain
Lysis
Acivorso soft tissue
reaction to particle
debris
Infection
Pain
Aseptic loosening
Lysis
2.2.2.2 Components removed and
components used
Both the acetabular and femoral components were
removed in approximately half of all revision procedures
(Table 2.12). However, comparison of the different
types of revision procedures indicates that both
components were more likely to be removed during
a two-stage revision process than during a singlestage revision. This is expected since the majority
of two-stage revisions are carried out for reasons of
infection, where all components are routinely removed.
The components used during single-stage revision
procedures are shown in Table 2.13.
Table 2.12 Components rernoved during hip revision procedures in 2012.
T
~
Both cup and stem
Acetabular cup only
B
^
Femoral stem only
Neither a ip nor stem
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DEMO-00085-00082
National Joint Registry
rqumci, Wares and Nor
Table 2,13 Components used during single-stage hip revision procedures in 2012.
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DEMO-00085-00083
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DEMO-00085-00084
The total number of knee replacement procedures
entered into the NJR during 2012 was 90,842,
an increase of 7.3% compared with 2011. Of the
90,842 procedures submitted, 84,833 were primary
procedures and 6,009 were revision procedures.
Table 2.14 summarises the patient characteristics and
details of knee replacement procedures according to
type of provider.
As a percentage of their activity, ISTCs performed
more unicondylar knee replacement procedures
(Figure 2.16) than any other type of provider and NHS
hospitals performed more cemented bicondylar knee
procedures than any other provider. The revision
procedures undertaken at NHS hospitals comprised
85% of all revision procedures performed.
Table 2.14 Procedure details. according to type of provider for knee procedures in 2012.
PI -fit and healthy
P2 - mild disease not
incapacitating
P3 - incapacitating systemic
disease
F4 and P5
Knee single-stage revision
Knee stage one of two-stage
revision
Knee stage two of two-stage
revision
Knee conversion 1o arthrodesis
Bilateral
Unilateral
8°c
3,873
369
45.825
72%
17,784
3,015
12,217
19%
1,829
276
317
Total prosthetic replacement
using comont
Total prosthetic replacement not
using cement
Hybrid, total knee
Pafello-femoral replacement
Unicondylar knoo replacement
Amputation
5,320
<1 %
18,597
51,703
20
6
15
<1%
i
< 1 %:
0
<1%
0
0%
21
0%
0
0%
6
374
2%
•16
1%
1,088
23,127
98%
3,616
99%
89.754
<1 %
BIB
668
63,01 1
1%
99%
1%
99%
Bilaterais will only be: counted as a bilateral if they.are entered under the same, single operation during data entry. If the two procedures are recorded under
two different operations they will be counted as two unilateral procedures. Therefore, the count of bilaterais is likely to be an underestimate.
w
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DEMO-00085-00085
Figure 2,16
Primary knee procedures by type of provider 2012.
100%
03
Q.
80%
60% o
40%
03
CD
co
c
03
£
20% -
03
0_
0%
Type of
provider
demented
5^
Cernentles
3%
4%
<1 %
Hybrid
<1 %
:1%
<1 %
1%
2%
1%
7%
12%
13%
58,556
22,749
3,528
Number of
procedures
23,1 Primary knee replacement
procedures 2012
Of the 84,883 primary knee replacements undertaken in
2012, 76,497 (90%) were bicondylar procedures (TKR),
7,065 (8%) were unicondylar knee replacements and
1,271 (1 %) were patello-femoral replacements (Table
2.15). Compared with previous years, these proportions
have largely remained the same (Figure 2.17) though
there has been a slight increase in cemented TKR at
the expense of cementless TKR over the past four
years. Figure 2.18 is based on total condylar knee
^ D
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82%
replacements where the meniscal implant has been
specified. The usage of unconstrained fixed implants
has increased gradually over the past six years at the
expense of unconstrained mobile constructs. Figure
2.19 shows that the usage of fixed constraint implants
has increased since 2006.
The single largest indication recorded for surgery
was osteoarthritis, recorded in 98% of all primary/
procedures (Table 2.15). All other indications were
recorded at 1 % or less.
wwvv,jijrcentre,orc|.ul'
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DEMO-00085-00086
P1 - fit and healthy
P2 - mild disease not
incapacitating
P3 - incapacitating
systemic disease
P4 and P5
Number with BMI
6,881
9%
280
10%
-16
10%
309
'VI %
1,573
22°.-
54,368
74%
2,092
77%
324
73%
864
68%
-1,93 7
709
1 1,8-10 16%
333
12%
j/\
17%
97
8%
536
8'.!
12,880
<19
268
251
<l%
6
<1%
2
<1%
1
<l%
8
51,084
70%
577
58%
306
69%
865
68%
5.282
75%
data
Average
SD
9,090
st3.1
14 /'0%
30.92
31.02
31.25
30.02
30.00
110.83
5.53
5.13
5.35
5.17
4.81
5.37
Pi
Osteoarthritis
Avascular necrosis
Inflammatory
arthropathy
Previous infection
Rheumatoid arthritis
71,384
97%
2,683
99%
428
223 < 1 %
3
<1%
3
:1%
2
500 < 1 %
964.1
11%
jjj|
1,233
97%
6,987
99%
81L720 98%
<1%
3
<1 %
55
<1%
287 < 1 %
--.-1%
-.)
<1 %
3
<1%
519
0
<-"1 *•'•••
67 < 1 %
63
<1%
2
<1%
0
0%
0%
1
< 1%
1,108
2%
15
<1%
4
<1%
1 <1%,
5
< I%
. 133
<!%
25
<1%
460
.- t ''•'••
35
<1 Li-
602
*.-1 cv-
Previous trauma
413
<\%
9
<.1%
8
2%
Other
507
<1 %
9
<1 %
9
2%
32
r
-K;-;
1c
t^
SwSSsSS
Bilatc
Left, unilateral
Right, unilateral
667
< I%
24
<1%
7
2%
90
7%
292
4%
1.080
1%
33,293
•17%
1,269
37%
203
46%.
504
4093
3,373
48%
39,642
47%
38,380
52%
1,3 18 52%
236
53%
677
53%
3,400
48%
44,111 52%
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Figure 2.17
Type of primary knee replacement procedures undertaken between 2006 and 2012.
UUVo
80% 60% 40% 20% r\a/n -
A,
;;;;;;;;dt
* • » TKR using cement
™#™ TKR not using
cement
7%
6%
6%
6%
5%
4%
3%
1%
1%
1%
1%
1%
1%
<1%
1%
<1 %
1%
1%
1%
:1 %
«^»» Patello-femoral
™#™ Unicondylar
8%
8%
8%
8%
8%
8%
8%
62,430
73,767
77,754
79,071
81,427
84,230
84,833
TKR Hybrid
Number of
procedures
ii
1%
D wwwj'ijrcentre.orvj.ul'
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*»»S-*"
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DEMO-00085-00088
Figure 2,18
Implant constraint for blcondyiar primary knee replacement procedures between 2006 and 2012.
80%
Z3
"U
CD
O
~~
60%
•*-•
o
40% -
g
20%
CD
0_
SS
•¥•
§,
^..
•?
0%
Year
*#»* Constrained
condylar
<1%
<1%
<1%
<1%
<1%
<1%
<1%
**#*» Posterior
stabilised, fixed
24%
24%
24%
25%
25%
25%
23%
2%
2%
2%
2%
2%
1%
1%
«#«* Unconstrained,
fixed
62%
63%
64%
65%
66%
67%
70%
Unconstrained,
mobile
11%
11 %
10%
8%
7%
6%
5%
Hinged/
linked
<1%
<1 %
<1%
<1%
<1%
<1 %
<1%
54,968
64,884
68,502
69,852
71,956
74,787
76,140
Posterior
stabilised, mobile
Number of
procedures
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1.3 Q
DEMO-00085-00089
Fiqure 2,19
Bearing type for unicondylar implant used in primary knee replacement procedures undertaken between
2006 and 2012.
80%
— -£•- —
7.0%
60%
50%
40% -
5
30%
20%
10%
0%
Year
*•#»» Fixed
25%
23%
24%
26%
30%
31%
36%
«#°« Mobile
75%
77%
76%
74%
70%
69%
64%
5,723
6,639
7,017
7,105
7,460
7,260
7,095
Number of
procedures*
' This is the number of procedures using a unicondylar meniscai implant regardless of patient procedure selected
2.3.1,1 Patient characteristics
According to the ASA grade system, 11 % of patients
undergoing a primary knee replacement procedure were
graded as fit and healthy (Table 2.15).
The average age of patients was 69.3 years and 57%
were female. Patients undergoing a patello-femorai
replacement were the youngest, at an average age of
59.7 years and 73% of these were female (Table 2.16).
On average, female patients were of a similar age to male
patients at the time of their primary knee replacement
(69.5 years and 68.9 years respectively), see Table
2.16. However, female patients were, on average,
older than male patients for cementless, cemented and
hybrid procedures but younger for patello-femorai and
unicondylar procedures.
Figure 2.21 shows the trend in ASA grade over the
past ten years. Since 2003, similar to the data trend for
total hip replacement, there has been a reduction in the
9
number of patients assessed as being fit and healthy
at the time of operation and an increase in P2 and P3
status of patients. Figure 2.22 shows the increase in BMI9
over the past nine years for patients having primary knee
procedures. This figure has progressively increased from
29.2 to 30.8 over the period. There has been a slight
decrease in BMI for female patients whereas the BMI of
male patients has continued to increase. It also shows
that there has been a steady increase in the number of
patients within the BMI range 30 to 34 and 35 to 39 and
a decrease within the ranges 20 to 24 and 25 to 29.
The average knee replacement patient in 2012, by BMI
measurement, was clinically obese. It is interesting to
note that the profile of Figure 2.22 is significantly different
to the equivalent chart for hips, Figure 2.7.
However, only 16% of entries in 2004 had BMI data
entered and while this has increased to 70% in 2012 all
BMI data has to be viewed with caution as surgeons may
be more likely to enter BMI data when the BMI is high,
introducing an element of bias.
BMI: 20-24 normai, 25-29 overweight, 30-39 obese, 40+ morbidly obese.
^
m
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1.31
DEMO-00085-00090
National 3»frtt Registry
:qi3n<\, Wares and No?
Table 2,16 Age and gender for primary knee replacement patients in 2 0 1 ;
<30 years
16 < 1 %
30 - 39 years
60
<1%
805
40 - 49 years
2
<1%
3
<1%
22 <1%:
27
3%
15
<l%
104 < l %
2%.
38
3%
5%
170
19%.
307
10%
1,331
3%
50 - 59 years
5.025 12%
192
1 eke
39
1 R%
296
33%
887
29%
6,439
14%
60 - 69 years
13,503 33%
464
35%
66
31%
226
25'%
1,083
35%
15,342 33%
70
15,145
37%
455
35%
61
28%
127
14%
622
20%
16/110 35%
6,187
15%
163
12%
33
15%
40
5%
146
5%
266 < 1 %
4
<1 %
4
2%
0
0%)
1
<1%:
9 yves
/e
80 - 89 years
90-
6.569
14%
275 <1%:
SSjSjSSS
<30 years
0
0%
0
0%
2
<1%
0
0%
8
Hk
30 - 39 years
36
<1%
1
<1 %
y
<1 %
6
2%
16
<1%
4 0 - 49 years
653
2%
44
3%
6
3%
43
13%
248
70.\,
994
3%-
50 - 59 years
3.665
12%
209
15%
28
13%
98
31%
922
26'%
4.922
14%
60 - 69 years
10,756 36%
508
37%
91
43%.
94
29%
1,449
40%
12,898 36%
70 - 79 years
11,023
37%
456
34 %
63
291,':
54
17%
767
21%
12,363 9'"%
80 - 89 years
3,737
12%
136
10%
24
11%
19
6'%
187
139 < 1 %
2
<1%
0
0%
3
<1%
6
90-
5%
<,A%
61 <1<%
4.103
12%
150 < 1 %
/.njixentreiorgaik
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1.32
DEMO-00085-00091
Figure 2.20
Age and gender for primary knee -replacement patients in 2012.
Female
Male
100%
^
D wwwj'ijrcentre.orcj.ul'
oW
| iW
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1.33
DEMO-00085-00092
ASA grades for prim any knee replacement patients between 2003 and 2012.
100% T
CO
CD
zs
80% -
o
o
60% -
Q.
O
CD
CO
40% -
CO
c
CD
G_
CD
GL
20% 0%
Year
PI
P2
58%
62%
65%
68%
73%
72%
73%
73%
74%
71%
P3
10%
13%
14%
14%
14%
13%
15%
15%
15%
15%
P4 and P5 <1%
<1%
:1%
:1%
<1%
:1%
<1 %
<1%
<1%
<1%
Number of
84,230 84.833
procedures 24,665 46,596 60,767 62,430 73,767 77,754 79,071 81,427
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1.34
DEMO-00085-00093
Figure 2.22
BMI for primary knee replacement patients between 2004 and 2012.
50%
32
„„c5x
31
...$•
45%
40%
30
35%
w«—«-#"
30%
29
25%
28
20%
27
15%.
10%
26
-
5%
25
XMSSSSS <s>
»!...SS:::5S
JB3
S
0%
« Average BMI
- ail patients
29.25
29.45
29.53
29.85
30.28
30.54
30.66
30.81
30.83
BMI 15-19
1%
1%
17%
14%,
1%,
15%
<1%,
14%
<1%
12%
<1%
11 %
<1%
10%,
d%
10%,
<1%,
10%,
BMI 25-29
38%
40 %
381
37%
36%
36%
35%
35%
34%,
BMI 30-34
29%
12%
291
30°%
13%
31 %
14%
32%
15%
32%,
15%,
32%
BMI 35-39
28%
11%
16%,
33 %
16%,
BMI 40-44
3%
4%,
4%
5%
5%,
5%
5%,
BMI 45+
1%
1%
1%
2%
2%
2%
2%
« Average BMI
- female
30.01
29.96
29.97
30.32
30.73
31.04
31.16
31.34
31.29
« Average BMI
- male
I I I BMI 20-24
3%
28.77
28.91
28.96
29.25
29.69
29.88
30.03
30.14
30.23
Percentage of
procedures
with BMI
16%
15%
17%
22%
49%
57%
61%
66%
70%
Number of
procedures
with BMI
5,509
9,101
10,579
16,110
38,207
45,200
49,930
55,409
59,114
2.3,1.2 Surgical techniques
The most common surgical approach was the medial
parapatellar, used in 93% of procedures (Table 2.17).
Minimally-invasive surgery (MIS) was used in 46% of
unicondylar knee replacement procedures, reflecting
the popularity of the Oxford Partial Knee, but was
used in only 2% of all other types of knee replacement
intervention. For cemented knee procedures, 38%
had the patella replaced at the time of the primary
procedure whereas only 7% of patellas were replaced
during primary cementless knee procedures.
94
....«
Compared with previous years, the surgical techniques
used in primary knee replacements have largely
remained unchanged. However, there has been
an increase in the use of MIS in unicondylar knee
replacements, from 37% in 2004 to 46% in 2012.
The use of bone cement in primary knee procedures is
summarised in Figure 2.23.
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DEMO-00085-00094
Table 2,17 Characteristics of surgical practice for primary knee replacement procedures in 2012, according to
procedure type.
yjSM4&t»&&^
Lateral
parapatellar
Medial
parapatellar
Mid-Vastus
90
20
68,359
Sub-Vastus
Otho
<1%
291
100% 84,542
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<1%
100%
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DEMO-00085-00095
Figure 2.23
Bone cement types for primary knee replacement procedures undertaken between 2003 and 2012.
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Year
Antibiotic-loaded
high viscosity
82%
84%
86%
87%
89%
91%
91%
91%
94%
Antibiotic-loaded
medium viscosity
3%
3%
3%
2%
3%
2%
2%
3%
2%
Antibiotic-loaded
low viscosity
2%
3%
2%
1%
<1 %
;1%
;1%
::1 %
High viscosity
6%
3%
2%
Medium viscosity
7%
4%
5%
4%
4%
4%
4%
3%
4%
3%
2%
3%
:1%
<1 %
69,710
71,979
Low viscosity
;1%
:1%
<1%
<1 %
Number of
procedures
using cement
18,396
36,472
50,062
52,656
2.3.1.3 Thromboprophylaxis
Table 2.18 shows that the most frequently prescribed
chemical method of thromboprophylaxis for knee
replacement patients was LMWH (72%), while TED
stockings were the most used mechanical method
(70%). Compared with previous years, there has
been an increase in the prescription of a combined
chemical and mechanical regime, from 49% in 2004
64,584
95%
<1 %
2%
;1 %
1%
<1%
<1%
0%
75,702
78,929
80,164
to 92% in 2012. There has been a marked decrease
over the past two years in the use of aspirin (from
20% in 2009 to 8% in 2012). Direct thrombin inhibitor
is now used in 13% of knee primary procedures and
the use of 'other chemical' has gone up from 7% in
2009 to 12% in 2012. This change was also seen
in hip primary procedures. Less than 1% of patients
had neither mechanical nor chemical-prescribed
thromboprophylaxis.
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DEMO-00085-00096
T?»hla O 1 a
Thr
Aspirin
lltoMrJi^
\lancimorit
? / ^ n W & H a t tinrv*a r\f
rvr\av3+\rvri
6,568
8%
:iil;illlllllllllllllllllll;il|il
Pentasaccharide
rWaifarim
Direct thrombin inhibitor
1,265
10,731
1% <2
13%
liH;
No chemical
3,118
4%
ifbjlipl^
Intermittent calf compression
36,027
ifllifoM
42%
•mm
Other
lip1r||g|ahic^
Both mechanical and chemical
1,177
1%
lllll
lllr
77,926
92%.
111111:
llollerkm^
2.3.1 .4 Untoward intra-operative events
Table 2.19 shows that untoward intra-operative events
were rare, reported in iess than 1 % of knee procedures.
There were fewer instances reported in 2012 compared
to 2011.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Table 2.19 Reported untoward intra-operative events for primary knee replacement patients in 2012, according to
procedure type.
Number of procedures
with no events specifi
^PPPs.SkPPP^
Fracture
Patella tendon avulsion
Ligament injury
Other
marketed by DePuy, continues to dominate the market.
The Triathlon, Genesis 2 and Vanguard appear to be
increasing in popularity.
2.3.1.5 Knee primary components
Figure 2.24 shows the leading brands of total condylar
knees in England and Wales. The PFC Sigma knee,
Figure 2.24
Top five total condylar knee brands, trends 2003 to 2012.
40%
.$
„„„_^„„„„„„„^—
30%
20%
10%
0%
Year
Number of
components used
21 627
§jh- PFC Sigma Bieondylar Knee
75.961
Nexgen
Triathlon
Genesis 2
H§™ Vanguard
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DEMO-00085-00098
Likewise, the market for unicondylar knees is dominated
by one product, the Oxford Partial Knee (Figure 2.25).
The market share of the Oxford Partial has decreased
gradually since 2003 and the Sigma HP, still relatively
new to the market, and the Zimmer Uni continue to be
the next most used brands of unicondylar knee system,
iqure
More information on the other brands used can be
found in the document 'Prostheses used in hip, knee,
ankle, elbow and shoulder replacement procedures
2012' which can be downloaded from the NJR website.
O *J'&\
Q
Top five unicondylar knee brands, trends 2003 to 2012.
Oxford Partial
Knee
Zimmer Uni
The brand usage for pateilo-femoral prostheses are
shown in Figure 2.26 and the equivalent graph for
Sigma HP
AMC/Uniglide
•••#••• Triathlon Uni
highly constrained and hinged revision knees is shown
in Figure 2.27.
w
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14Q
DEMO-GQ085-0G099
Figure 2.26
Top five patello-femoral knee brands, trends 2003 to 2012.
80%
70% 60%
50% H
40%
30% -\
20%
10% H
0%
§™ Avon
100
^ D
^w * 1
ZimmerPFJ
™#™ FPV
Sigma HP
Journey PFJ Oxinium
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DEMO-00085-00100
gurs k
Top five fixed hinged knee brands, trends 2003 to 2012.
60%
50%
40% H
>S"-~
._
10%
20% "
10%
0%
Number of
components usea
^
Endo Rotatmq
y
™#™ ...
Hinge
,-t
A
^
<
«•»
J
129
195
Nexaen Hinqe
M
•••*;;;:•••• _ Type
262
213
^, .,,->,,
™#— MRH
Knee revision procedures 2012
A total of 6,009 knee revision procedures were
reported, an increase of 17% on 2011. Of these,
4,675 (78%) were single-stage revision procedures,
601 (10%) were stage one of a two-stage revision
282
307
*= r-,-i-r,.
—#•- RT-Pius
305
306
294
«* .., •.
™#™ Noiles
and 706 (12%) were stage two of a two-stage
revision (Table 2.20). A further 27 procedures were
recorded, comprising 21 conversions of previous knee
replacements to arthrodesis and six knee amputations.
Compared with previous years, there has been no
change in the types of revision procedures carried out.
w
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DEMO-00085-00101
h t r / q . i a r c. r a x /
60.76
60.7/
60.87
71 71
70.62
10.4/
10.2ft
0 /-9
0.00
12.26
PS 60 //.I2
6 / . 56 ,'6.06
68.63 -
61.// ,6.03
68 ^ 1 ,V.20
Fe-na a
2/166
!•>•• 7,2-' 2
•2%
29a
•\r>.
Mac
2.000
•'68)
58%
302
5/%
0
3/1
10
68.9
10.6,
62.00
,,3%
1
11
i.018
527,
:.023
/8%
K"5v*vti¥NX^
%78
rj-v,
3I
6 7,
88
P2 - Tr c c sease no: r c a p a c i t a t r g
3,2 I /
69%
366
61%
A 3/
6I77
10
4.029
P3 - •"'caoaoLa. '"g sys.c-Tic c sc-asc
1.005
21%
102
0 ^ :'d
230
33%
11
1.4/2
45
l%
12
2 7,
n
17,
0
I >' - tit a id lioaltny
p/i a-x-J P->
fSPj^™;,,.
§sisiS0JSS(^
0
0%
%"2
.,...., ,™
Asoo".ic loose i ng
Pa 10 7,
Lys a
Wear of o o y e x y e^e ccinpoee-it
hs.ab iLv
hfcc.ior
Maaigameat
St-reas
Pogrossvo axhriL s T-'iiah eg
Diaooa.ior.-s.jo axa. o "
pa- o'osThe- o "''ao:i,re
32%
006
15%
605
8%
x9i
|0%
r,63
12%
792
17%
840
V%
265
6x,
1.826
22%,
868
8%
29/
6%
54 0
127b
I 7,
0
0%
17,
2
10%
17b
o
U':'b
188
2 7>
0
O'.'i;
18/
i -.'• •
. I .'•,
86
Go-"noorcix dissocial o-"
Z-0
1.332
Z'b
•-1 ?"0
10
200
92
0
•17b
87,
2%
0'';.
I-no la a I '•a<\.,"0
Ol-n-
20/
i
I
2
m
Ln!.. i.-.lalo-a
2,168
Righc. i.r lale'ai
2.3.2.1 Patient characteristics
The mean age of knee revision patients was 69 years
(Table 2.20). The average has decreased by 0.5 years
compared with 2011. There were more female (52%)
than male patients (48%) which is similar to 2011.
Aseptic loosening was the most common indication for
[02
^ D
^^ v S - * '
O'/c
0
627b
2
38%'
A
single-stage revision (38%) and infection was the most
common indication for two-stage revision, conversion
to arthrodesis and amputation.
Compared with previous years, the patient
characteristics described above have largely remained
the same.
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DEMO-00085-00103
The NJR started recording primary and revision total
ankle replacements on 1 April 2010. By reviewing
submitted procedures against ankle levy submissions,
we have calculated compliance of ankle joint NJR
submissions to be 77%, which is improving on previous
years but further work is required.
A total of 590 ankle replacement proformas, comprising
540 primary and 50 revision procedures carried out
between 1 January and 31 December 2012, were
submitted to the NJR by 28 February 2013. Due to the
small number collected so far the procedures tables in
this section are displayed at a summary level only. Of
all the ankle procedures carried out 86% were funded
by the NHS. 84% of patients were classified as P1
- fit and healthy (15%) or P2 - had rnild disease not
incapacitating (69%), (Table 2.21)
procedures performed were reported as being
uncemented but the use of cement was reported in five
cases, three of which pertained to a hybrid procedure.
2.4,1,1 Patient characteristics
The average age of female patients was 64.7 years
whereas the average age for a male patient was
68.8 years. 58% of patients were male (Table 2.22).
The BMI average was 29.0, which is higher than for
hip primary procedures but lower than knee primary
procedures. No bilateral procedures were submitted
to the NJR and 55% of procedures were performed
on the right ankle. 84% of patients had their procedure
performed due to osteoarthritis and 13% due to
inflammatory arthritis. The pre-operative range of
movement and degrees of deformity can be seen
in Table 2.21.
2,4,1 Primary ankle replacement,
procedures 2012
Of the 540 primary procedures, 414 (77%) were
performed in the NHS, 107 (20%) in the independent
sector and 19 (3%) in ISTCs. Almost all of the primary
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DEMO-00085-00104
National Jsirtt Registry
;qiend, Wares
No?
Table 2.21 Patient characteristics for primary ankle replacement procedures in 2012.
16-45'
Not available
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DEMO-00085-00105
Table 2.22 Age and gender for primary ?r
'acement patients in 2012.
<'15 years
'15 - 54 years
20
21%
55 - 64 years
64
65 - 74 years
130
43%
75 - 84 years
75
25%
2%
>85 years
2.4.1.2 Surgical techniques
Table 2.23 details the surgical technique used during
ankle primary procedures. Additional ankle related
procedures were performed in 36% of procedures.
^ D
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Achilles tendon lengthening was performed in 11 % of
procedures and subtalar joint fusion in 6%. Bone graft
was used in 15% of procedures.
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DEMO-00085-00106
Table 2.23 Characteristics of surgical practice for primary ankle replacement procedures in 2011
.SsssssssssssssssssssS
mm
Anterior
Anterolateral
Lateral (transfibular)
Othor
Subtalar joint fusion
Talonavicular fusion
Calcaneal displacement ostcotomiy
Achilles tendon lengthening
Fusion distal tibiofibular joint
Fibula osteotomy
Medial malleolar osteotomy
Lateral ligament reconstruction
Medial ligament reconstruction
Other
None
Yes
No
Ye?
No
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
2,4,1.3
Thromboprophylaxis
only 2 % used neither mechanical nor chemical
regimes. L M W H w a s the most popular chemical
Table 2.24 s h o w s that 8 0 % of primary ankle
t h r o m b o p r o p h y l a x i s regime used in 8 0 % of total
replacement procedures used botfi chemical a n d
ankle replacement (TAR) procedures.
mechanical t h r o m b o p r o p h y l a x i s regimes and
Table 2.24 Thromboprophylaxis regime for primary ankle replacement patients, prescribed at time of operation.
Aspirin
26
Low molecular weight Heparin
430
80%
Pentasaccharide
0
0%:
Warfarin
8
Direct thrombin inhibitor
16
Other chemical
62
on
No chemical
70
I O'/fi
Intermittent calf compression
154
29%
TED stockings
303
56%
Foot pump
Other mechanical
No mechanical
Both mechanical and chemical
Neither mechanical nor chemical
2.4.1,4 Untoward intra-operative events
37
16%
432
80%
11
2%
w a s 'Fracture of the medial malleolus' which occurred
in 15 primary procedures (3%).
In 4 % of procedures an untoward intra-operative event
w a s reported. Of those reported the most c o m m o n
Table 2.25 Reported untoward intra-operative events for primary ankie replacement patients in 2 0 1 2 .
n
SSSSSSSSS!
iSlliili
Fracture of medial malleolus
15
lipefbr^
Fracture (other)
3
(ligSrrtJh^
Other
^ D
^w * 1
4
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DEMO-00085-00108
shoulder replacement procedures 2012' which can be
downloaded from the NJR website.
2.4.1.5 An kLe primary comporients
The DePuy Mobility ankle prosthesis was: used in 52%
of all primary procedures recorded in 2012. The next
most commonly used prosthesis was Corin's Zenith
ankle replacement at 20% followed by MatOrtho's
BOX prosthesis at 8%. More information on the
other brands used can be found in the document
'Prostheses used in hip, knee, ankle, elbow and
2.4.2 Ankle revision procedures 2012
Of the 50 revision procedures, 46 were performed in
the NHS (92%). 66% were single-stage revisions and
22% were conversion to arthrodesis.
Table 2.26 Details for ankle revision procedures in 2012.
Single-stage revision
::S|ngte-stage::^
Prosthetic replacement not classified elsewhere (e.g. hybrid)
PrpSthetieTepj^
Stage one of two-stage revision
Stage two of two-stage revision
Prosthetic replacement not using cement
1§t(i|g:ty|m
Conversion to arthrodesis
IPrp^hM^
Conversion to ankle fusion (subtalar joint not fused)
:jCd|y§itsidiim
Conversion to arthrodesis
::C:phV3:t)|i|g|^
Conversion to ankle & subtalar fusion (using ttc nail)
2,4.2.1 Patient characteristics
The average age for a patient having a revision
procedure was 64.7 years. Only 12% were fit and
healthy and 24% had severe systemic disease (P3).
36% of revisions were for undiagnosed pain and 20%
due to infection - low suspicion.
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Table 2.27 Patient e h a r a c + Q r i o + i ' ^ ' ' ' w
T I procedures in 20.12.
P i - fit and healthy
P2 - mild disease not incapacitating
32
P3 - incapacitating systemic disease
12
P i and P5
2-1%
0%
Infection high suspicion
6%
20%
Infection low suspicion
Aseptic loosening - tibial
13%
Aseptic loosening - taiar
16%
Lysis - tibia
Lysis - talus
Malalignment
i 8%
Implant fracture - tibia
Implant fracture - taiar
2%
Implant fracture - rnenisca!
10%
Wear of polyethylene component
Meniscal insert dislocation
0%
Component migration/dissociation
Pain (undiagnosed)
36%
Stiffness
8%
Soft tissue impingement
Other
liisiLBhilaferaf
Right, unilateral
29
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58%
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DEMO-00085-00111
The NJR started recording primary and revision elbow
replacements on 1 April 2012. This Annual Report
therefore deals with nine months of operation data (1
April to 31 December 2012).
A total of 288 elbow replacement procedures,
comprising 214 primary and 74 revision procedures
carried out between 1 April and 31 December
2012, were submitted to the NJR by 28 February
2013. Due to the small number collected so far the
procedures tabies in this section are displayed at a
summary level only.
2.5,1 Primary elbow replacement
procedures 2012 (nine months)
independent sector. 88% of the primary procedures
were total elbow replacement procedures and
9% were radial head replacements only (Table
2.28). Primary procedures were mainly performed
due to other inflammatory arthropathy (33%) and
osteoarthritis (32%).
2.5,1.1 Patient characteristics
The average age of female patients was 66.9 years
whereas the average age for a male patient was 65.6
years. 67%o of patients were female (Table 2.29).
83% of patients were right handed and 3% were
ambidextrous. Table 2.29 shows that 54% have
ASA grade of P2 and 34% have P3 - incapacitating
systemic disease.
Of the 214 primary procedures, 200 (93%) were
performed in the NHS, and the remaining in the
Table 2.28 Details for primary elbow procedures in 2012 (nine months),
M.4sftWiilswS^
Primary' radial head replacement
20
9%
188
6
88%
3%
Osteoarthritis
69
32%
Other inflammatory arthropathy
70
33%
0
0
0%
0%
Acute trauma
50
23%
Trauma sequelae
Failed hemiarthroplasty
29
1
14%
<1%
7
3%
Left
119
56%
Right
95
44%
190
10
89%
5%
Independent
14
7%
Independent
12
6%
Primary total prosthetic replacement
Primary laleral resurfacing
Essex Lopresti
Avascular necrosis
Other
NHS - England
NHS - Wales
liiiiiiii^
^
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DEMO-00085-00112
Table 2.29 Patient characteristics for primary elbow replacement procedures in 2012 (nine months
PI - fit and healthy
P2 - mild disease not incapacitating
115
P3 - incapacitating systemic disease
73
34 %
P4 and P5
Ambidextrous
Left
Right
sllllll^W«t4w dp
SSls4JJsSMii®si;*S^I
Average
SD
Interquartile range
66.9
'o
s
14.7
.g
59.6 - 77.4
§¥&&WK§&yK«§:
Average
SD
Interquartile range
65.6
13.9
58.0-74.5
^^^^IsSl^^^^^
VBBI
<45 years
18
•15 - 54 years
20
10%
9%
55 - 5-1 years
40
20%
65 - 74 years
61
3 Do
75 - 84 years
41
21 %
>85 years
16
2*5.1,2 Surgical techniques
Table 2.30 details the surgical technique used during
elbow primary procedures. 89% of elbow procedures
were performed using a posterior approach and
less than 1 % used image-guided surgery. 16% of
replacements required humeral bone grafting but
less than T% required an ulnar bone graft. 8% of
procedures resulted in an untoward intra-operative
event with fracture of the humerus occurring in 39% of
these and shaft penetration of the ulna in 33%,
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Tabie 2.30 Characteristics of surgical practice for primary elbow replacement procedures in 2012 (nine months).
2.5.1.3 Thromboprophylaxis
Tabie 2.31 shows that 90% of elbow replacement
procedures used mechanical methods and 66% used
chemical methods; 60% of primary procedures used
both chemical and mechanical thromboprophylaxis
regimes. 4% used neither mechanical nor chemical
regimes. LMWH was the most popular chemical
thromboprophylaxis regime used in 59% of procedures.
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DEMO-00085-00114
T-nKIa O O i T h r
^ ^ . r ^ r n ^ r k t r \ o f i ^ i +o
"
prescribed at time of operation.
Aspirin
(ill::
o%
ill
Pentasaccharide
0
ii^aiariiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii
Direct thrombin inhibitor
mtm
2
<1%
11;
Iii;l
34%
No chemical
iiiooi piyjftpgggggg
Intermittent calf compression
iflitgfod^
Other mechanical
iiNblmeclplclill:;:
Both mechanical and chemical
2,5,2 blbow revision procedures 2012
Of the 74 revision procedures, 74% were singlestage revisions (Table 2.32). Aseptic loosening
accounted for 50% of the reasons for revision.
23%;
81
|
38%
ill
mm
3
1%
ill
lii:;
129
6:0%
lli
111%:;
67% of the patients were female and their average
age was 65.3. The average age for male patients
undergoing revision was 63.9.
w
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DEMO-00085-00115
Table 2.32 Details for elbow revision procedures in 2012 (nine months).
Single-stage re\'ision
Revision to lateral resurfacing
Sling lo-stago revision
Revision total prosthetic rcplaccrnont
54
6
Revision total prosthetic replacement
10
Stage one of two-stage revision
Stage two of two-stage revision
1
1%
73%
8%
wi%
Excision arthroplasty
Aseptic loosening
Infection
Instability
Pcnprosthctic fractun
Other
13.1
55.0 - 72.4
2.5.3 Elbow components used in
primary and revision procedures
The Zimrner Coonrad Morrey had 45% of the market
share in total elbow replacement prostheses used
in primary and revision procedures.. For procedures
^ D
^w * 1
where only the radial head was replaced, the
most used brand was the Anatomic Radial head
manufactured by Acumed. More information on the
other brands used can be found in the document
'Prostheses used in hip, knee, ankle, elbow and
shoulder replacement procedures 2012' which can be
downloaded from the NJR website.
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DEMO-00085-00116
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DEMO-00085-00117
The NJR started recording primary and revision shoulder
replacements on 1 April 2012. This Annual Report
therefore deals with nine months of operation data (1
April to 31 December 2012).
A total of 2,225 shoulder replacement procedures,
comprising 1,968 primary and 257 revision procedures
carried out between 1 April and 31 December 2012,
were submitted to the NJR by 28 February 2013. Due to
the small number collected so far the procedures tables
in this section are displayed at a summary level only.
2.6,1 Primary shoulder replacement
procedures 2012 (nine months)
Of the 1,968 primary procedures, 1,630 (83%) were
performed in the NHS sector and the remaining in the
independent sector. The most frequently performed
primary procedure was the reverse polarity total shoulder
replacement at 597 (30%) followed by the standard
polarity total shoulder replacement with 525 (27%)
procedures (Table 2.33). Primary procedures were mainly
performed due to osteoarthritis (61 %) and cuff tear
arthropathy (24%).
2.6.1.1 Patient characteristics
The average age of female patients was 73.2 years
whereas the average age for a male patient was 68.8
years. 72% of patients were female (Table 2.34). 84% of
patients were right handed and 4% were ambidextrous.
Table 2.34 shows that 62% had ASA grade of P2 and
28% have P3 - incapacitating systemic disease.
Table 2.33 Details for primary shoulder procedures in 2012 (nine months).
Primary total prosthetic replacement
Primary hemiarthroplasty of joint
Primary resurfacing arthroplasty of joint
Primary resurfacing hcmi-arthoplasty of joint
Primary reverse polarity total prosthetic replacement
525
27%
296
15%
122
6%
428
22%
30%
597
sssssss
Osteoarthritis
Cuff tear arthropathy
Other inflammatory arthropathy
Avascular necrosis
Acute trauma
Trauma sequelae
Other
Left
i ,202
6i%
470
24%
112
6%
4%
81
92
11 1
54
921
47%
Right
1,0-17
NHS •• England
1,567
80%
63
289
49
2%
151
.817
8%
92%:
NHS - Wales
Independent
ISTC
UH
Independent
NHS
^ D
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DEMO-00085-00118
Table 2.34 Patient characteristics for primary shoulder replacement procedures in 2012 (nine months).
t^a>u^^^^^^
2,6.1.2 SurgicaL techniques
Table 2.35 details the surgical technique used during
shoulder primary procedures. 75% of shoulder
procedures were performed using a delto-pectoral
approach and less than 1 % used image-guided
surgery. 12% of replacements required humeral bone
graft and 4% required glenoid bone graft. Long head
biceps tenotomy was required in 45% of procedures
and 43% had normal rotator cuff condition. 2% of
procedures resulted in an untoward intra-operative
event with vascular injury occurring in 44% of these.
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Table 2.35 Characteristics of surgical practice for primary shoulder replacement procedures in 2012 (nine months)
^)fsp§;
Deltoid detachment
Deltoid split
Delto-pectoral
Posterior
Superior (MacKcnzie)
2.6.1.3 Thromboprophylaxis
Table 2.36 shows that 93% of shoulder replacement
procedures used mechanical methods and 65% used
chemical methods; 61 % of primary procedures used
both chemical and mechanical thromboprophylaxis
regimes. 4% used neither mechanical nor chemical
regimes. LMWH was the most popular chemical
thromboprophylaxis regime used in 57% of procedures
and TED stockings, the most popular mechanical
thromboprophylaxis, were used in 60% of procedures.
^
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DEMO-00065-00120
T ^ K I a O Q£ T h r
i l H ^ i r rQr\!cs^»CirY^Cirit
^ +i ents, prescribed at time of operation,
Aspirin
3%
Low molecu lar weig ht Heparin
Pentasaccharide
<1%
iiiiilillllllllllllllllllllllll;:;
Direct thrombin inhibitor
;;lilll|l|ili|llllllllllllll;ll
No chemical
r|Qp|i|ump|||||^
intermittent calf compression
iilllfsibcltih^
Other mechanical
fi©|iieph^^
Both mechanical and chemical
iilNifhdhmleh
iiii
35
2%
III
!§§§!
35%
695
llil
ills
802
41 %
;ifi;illllllllllllllllllio%|
18
<1%
!!!;lll!!!!!!!!!!!!!l
1,202
61%
!!!!!!ll!i!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!I%!
2.6.2 Shoulder components used in
primary procedures
2,6,3 Shoulder revision procedures
2012 (nine months)
The Delta Xtend reverse shoulder from DePuy had
22% of the total shoulder replacement market for
primary procedures. The Copeland shoulder system
from Biomet has 27% of market share for primary
resurfacing. More information on the other brands
used can be found in the document 'Prostheses used
in hip, knee, ankle, elbow and shoulder replacement
procedures 2012' which can be downloaded from the
NJR website.
Of the .257 revision procedures, 86% were singlestage revisions (Table 2.37). Conversion from a
hemi to a total was the cause for 30% of revision
procedures performed. 68% of the patients were
female and their average age was 69.9. The average
age for male patients undergoing revision was 68.5.
w
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DEMO-00085-00121
Table 2.37 Details for shoulder revision procedures in 2 0 1 2 [nine months).
Single-stage revision
Revision heini-arthroplasty of joint
27
11%
Single-stage revision
Revision tcsuifacing arthoplasty of joint
13
5%
„.
9
4%
„. ,
..
Sinqle-staae
revision
s
-
Revision resurfaoina hemi-arthoplasty
,. . .
of joint
Revision reverse molarity total prosthetic
.
'
4
replaeernent
, ,s,,
i (;9
„..,,,.
42%
Single-stage revision
Revision total prosthetic replacement
63
25%
,
..
Smqlc-stage revision
Stage o n e of t w o - s t a g e revision
Stage t w o of t w o - s t a g e revision
Revision hemi-arthroplasty of joint
1A
5%
A
2%>
Stage t w o of t w o - s t a g e revision
Revision resurfacing arthoplasty of joint
I
<1%
„.
.
,,
,
. .
Siagc two of two-staqo revision
a
Stage two of two-stage revision
Revision reverse polarity total orosthetio
.
.
'
•
replacement
Revision total prosthetic replacement
.,
11
.,,.
4%
6
2%
Aseptic loosening
36
\A%
Conversion hemi to total
77
30%
Conversion total to hemi
Cuff insufficiency
1
<1%
65
25%:
Infection
25
10%
instability
34
13%
Periprosthetic fracture
11
A%
Other
60
23%
Left
128
50%
Right
129
50%
Average
69.9
SD
9.1
Interquartile range
Average
64.9 - 75.5
68,5
j ^jg;!;!;!;!;!;!;!;!;!;!;!;^
Interquartile range
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62.8 - 75.4
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DEMO-00085-00123
The outcome analyses have been based on all
patients with at least one primary joint replacement
carried out between 1 April 2003 and 31 December
2012, inclusive, and whose record had been
submitted to the NJR by the end of February 2013.
Documentation of implant survivorship and mortality
require a person-level identifier to relate operations
carried out on the same individual. Starting with a
total of 1,419,738 NJR source file records, around
12.9% were lost because no suitable person-level
identifier was found. In around half of these (48.7%),
the patient had declined to give consent for details to
be held, the remainder being attributable to tracing
and linkage difficulties. A person-level identifier was
available for 95.9% of operations from 2008 to
2012 but, in earlier years, the proportion had been
much lower, for example, it was 58.9% in 2004. The
implication of this is that the subset of patients with
longer follow-up may be less representative than
those patients with shorter follow-up.
Amongst the patients with person-level identifiers, 4.7%
had solely revision operations recorded within the time
frame, i.e. they had no primary operation record in the
NJR. This was either because the primary had taken
place at an earlier point in time (before the NJR data
collection period began in 2003) or it had not been
included for other reasons; these cases were excluded.
This left 945,196 patients with at least one record of
a primary joint replacement within the NJR, i.e. hips,
knees, ankles, elbows or shoulders.
At the joint level, some further revisions were excluded if
they could not be matched to primary joint replacements.
For example, if a primary operation was recorded only for
one side and there was a documented revision for the
other side, the latter was excluded.
The resulting data sets are shown in Tabie 3.1. Shoulder
and elbow replacements are not shown here but will be
included in a later Report. Separate sets of analyses have
been carried out for hips, knees and ankles, although the
numbers for the latter are still quite small.
Table 3.1 Summary description of datasets used for survivorship analysis.
Summary of data
)§f|l&;)^
Data exclusions
All NJR procedure-level data restructured to person-level
- Excludes data where patient-level identifier is not present
- Excludes patients where no primary operation is recorded in the NJR
- Excludes any revisions after the first revision
|i|NimiePo^
Number of revisions linked to a primary operation
NJR identified primary-linked first revisions:
11,780 hips; 11,666 knees; 9 ankles
Table 3.2 opposite shows the composition of the three
data sets. Of the 478,730 patients with primary hip
operations 12,6% had operations documented for both
hips; likewise 19.5% of the 499,015 patients with knee
operations had operations on both sides.
implant survivorship is later described with respect to
the lifetime of the primary joint only, i.e. we have looked
only at time to first revision, hot:the time from a revision
^ D
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operation to any subsequent one. Table 3.2 shows the
number of subsequent revision procedures and these
numbers are small.
The unit of observation for all sets of survivorship
analysis has been taken as the individual primary joint
replacement. A patient with left and right replacements
of a particular type, therefore, will have two entries,
and an assumption is made that the survivorship of a.
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DEMO-00085-00124
replacement on one side is independent of the other. In
practice it would be difficult to validate this, particularly
given that some patients had had prior replacements
not recorded in the NJR. Risk factors such as age
are recorded at the time of primary operation and will
therefore be different for the two procedures unless the
two operations are performed at the same time.
Figure 3.1 shows the overlap amongst patients in the
dataset. For example, 443,190 patients had only hip
operations in the data base, 35,422 had both hip and
knee replacements and a further 24 had hip, knee and
ankles. We stress this is only the composition within the
NJR; ankle operations have only recently been included
and so the figures are not generalisabie.
A further complication is that patients may have more
than one type of implant.
Table 3.2 Composition of person-level datasets for survivorship analysis
Number (%) of patients with only one primary joint operation
Number {%) of patients with different operation dates for loft and
right sides of the same primary joint
Number (%) of patients with bilateral operations (both sides of the
same primary joint replaced at the same timet
Number with at least one revision operation linked to the primary
Number with more than one revision procedure
Figure 3.1
Patients with hip, knee and ankle primary operations within the survivorship data sets.
35,422
201
24
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§4
i dm
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DEMO-00085-00126
This section looks at revision and mortality for all
primary hip operations performed between 1 April
2003 and 31 December 2012. Patients operated on at
the beginning of the registry therefore had a potential
for nearly 10 years follow up.
Methodological note
Survival analyses have been used throughout this
section, first looking at the need for revision and then
looking at mortality. For revision, only the first revision
has been considered here. The majority of implants
did not require revision and survival analysis made
use of the information that was available on them,
i.e. that they had not been revised up to the end of
the follow up period (the end of 2012) or prior to their
death; these observations were regarded as being
'censored' at those times. For mortality, the event
was death, censoring only those cases that were
still alive at the end of 2012 (and not for any revision
procedure).
The survival tables below show 'Kaplan-Meier'
estimates of the cumulative chance (probability)
of revision, or death, at different times from the
primary operation. This is instead of the NelsonAaien estimates of 'cumulative hazard' used in earlier
annual reports, a change that brings us more into
line with other registries. Please see the Annexe
to Survival Analysis at the end of the chapter for a
fuller explanation of the change. Where rates are
Terminology note
The six main categories of bearing surfaces
for hip replacements are ceramic-on-ceramic
(CoG), ceramic-on-metal (CoM), ceramic-onpolyethylene (CoP), metaf-on-metal (MoM), metalon-polyethylene (MoP) and resurfacing procedures.
The metal-on-metai group in this section refers
Details of the patient cohort are given in Tables 3.1
and 3,2 of the preceding section; a total of 539,372
hips were included.
very small, the cumulative probability and cumulative
hazard are numerically very similar, but with more
extended follow up, they have started to diverge.
Cumulative hazard estimates have continued to
be used for graphs that compare the survival
experiences of different sub-groups. Although
either Kaplan-Meier or cumulative hazards could be
used for visual comparison, the latter have some
advantage - again see our Annexe.
The cumulative hazard plots now also include tables
of the numbers at risk at each anniversary. These
are particularly useful where a particular group has
appeared to 'plateau' it may simply be because the
number of cases fell so low that the occurrence of
further revisions/deaths became unlikely.
All the Kaplan-Meier estimates shown have been
multiplied by 100, therefore estimate cumulative
percentage probability.
In the case of revisions, no attempt has been made
to adjust for the competing risk of death,
to patients with a stemmed prosthesis and metai
bearing surfaces (a monobloc metal acetabular
cup or a metal acetabular cup with a metal liner).
Although they have metal-on-metal bearing
surfaces, resurfacing procedures, which have a
surface replacement femoral prosthesis combined
with a metai acetabular cup, are treated as a
separate category.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
3.2,1 Overview at primary hip surgery
The most commonly used type overall remained
cemented metal-on-polyethylene (33%).
Table 3.3 below shows the breakdown of cases by
method of fixation and, within each fixation sub-group,
by bearing surface.
Ail cemented
Ail uncomerrtod
All hybrid
201,580 f37.4 r
205,3 i 7 138.1Vi
84,671 [15.731-1
Ail reverse hybrid
12,296(2.3%)
All resurfacing
3 5 / 7 0 [6.6%)
38(<0.1%)
Unsure
MoP
MoM
CoP
Others/unsure
MoP
MoM
CoP
GoC
GoM
Others/unsure
MoP
MoM
GoP
CoC
Others/unsure
MoP
GoP
178,077 (33.0%)
1,229 (0.2%)
17,202(3.2%)
5,072 (0.9%)
71.762(13.9%)
28,367 (5.3%)
27,961 (5.2%)
67,922(12.6%)
2,017 (0.1%)
4,285 (0.8%)
55,585 (10.3%)
2,297 (0.4%)
9,720(1.8%)
15,239(2.8%:)
1,830 (0.3%)
Others/unsure
8,397 (1.6%)
3,816(0.7%)
83 (<0.1%)
(MoM)
35/170 (6.6%)
Unsure
38 i<0.1 %)
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DEMO-00085-00128
Table 3.4 shows the distribution of fixation/bearing
surface groups for each year of primary operation,
time whereas the percentages of both the uncemented
and hybrid metal-on-polyethylene have been increasing.
The percentage of cemented metal-on-polyethylene,
the most popular type of implant, has been falling with
The proportions of metal-on-metal and resurfacing
implants have been falling since 2.008.
Table 3.4 Percentage of primary hip replacements performed each year by type of hip fixation and constraint.
4s*M,44i4li
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DEMO-00085-00129
procedures of that type, together with the median and
IQR of the number of procedures they carried out.
The primary operations were carried out by a total
of 2,772 consultant surgeons across 456 units. The
median number of primary procedures per consultant
was 64, inter-quartile range (iQR) 10-244 and the
median number of procedures per unit was 910.5,
IQR 419.5-1677.
Surgeons performing cemented THR carried out a
median of 43 operations over the period they were
observed with IQR 13 to 126 procedures. This means
that 25% of surgeons performed fewer than 13
cemented hip replacements and 25% more than 126,
Additionally, 10% of surgeons carrying out cemented
hip replacements had performed between 782 and
1,390 procedures (not shown in table). Similarly,
the surgeons with the highest 10% of caseloads
performing uncemented THR carried out between 917
and 2,614 procedures over the period of observation.
Table 3.5 below shows the distributions of consultant
surgeon and unit caseloads for each type of fixation;
consultants and units with fewer than 10 cases in
the database have been excluded (683 of 2,772
consultant surgeons and 11 of 456 units).
The table shows, for each fixation type, the
percentage of surgeons or units that carried out
Tabie 3.5 Distribution of consultant surgeon and unit caseload for each fixation tyoe.
Cemented
'13
(13-12(5)
252
83-645)
Unoornontod
38
(8-147)
296
(• 120.5-622.5)
Hybrids
1 1
(3-50)
94.6
69
o
f 1-8.5)
74 .4
6
(14-208)
(2-25)
12
(2-46)
88.1
46
(14.5-107)
Reverse hybrids
3h.o
Resurfacing
37.2
The median age at operation was 69 (IQR 61-76;
range 7-105) years.10
sub-group. On the whole, resurfacing and ceramicon-ceramic bearings tended to be used in younger
patients although the age ranges were wide.
Table 3.6 gives the breakdown of ages by fixation
and by the main bearing surfaces within each fixation
15 ages were 0 arid assumed missing.
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17.1
DEMO-00085-00130
Table 3.6 Age (in years) at primary hip replacement, by fixation and main bearing surface.
Resurfacing and
MoM
r
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li ":>Hi:;r/uii:»ur:!' b:,;.riic.
55 (•19-60)
T l i : U x ; i ; n i f . siirU;::. fur ill;
illior or uiiiiur;: so nol
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3«£
Revisions after primary hip surgery
Table 3.7 shows Kaplan-Meier estimates of the cumulative
percentage probability of first revision, for any cause, for all
cases combined and then subdivided by fixation and bearing
surface within each fixation group. Estimates are shown,
together with 95% Confidence Intervals (95% CI), at 30 and
90 days after the primary operation and at each anniversary
up to the ninth year. These do not adjust for other factors
such as age and gender.
At time points where the estimates are shown in italics, fewer
than 100 cases remained at risk; if the numbers at risk are
small, revisions, as they occur, may appear to have greater
impact on the failure rate estimates, i.e. the step upwards
may appear steeper.
was highest for metal-on-metal. This is further exemplified by
Figure 3.2, where the cumulative hazard for the three bearing
surface groups are plotted together. The shaded bands in
these figures indicate point-wise 95% Cls for the estimates.
A similar picture exists for uncernented hips, see Figure
3.3, namely that the metal-on-metal revision rates were the
highest, higher even than those for resurfacing.
Amongst the hybrid hips, again the revision rates for metalon-metal were highest - see Figure 3.4.
For the cumulative hazard curves for metal-on-metal in
Figures 3.2 to 3.4, the tangents appeared to increase over
the 9 years of follow up, suggesting that the hazard rate (the
rate of revision amongst the unrevised cases) increased with
time from primary operation.
Amongst the cemented hips, the revision rate at nine years
/mjixentre. : orguik
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DEMO-00085-00131
Table 3.7 Kapian-Meier estimates of the cumulative percentage probability of first revision (95% CI), at different times after the primary operation,
for each fixation/bearing surface sub-group. R.r Hu: xevr-rfry-,:•'(•••.:<••yycy. {cs,>c: tnn-i ';QQ onsoo -'e^a/a af r-:-y-..
M
0 12
lO 87-0 47.
0 3!
(0 28 0 39)
0 30
10 2-1 0 37)
0 84
II'; 29-0 33)
0 k10.05 0 4Pi
0..'/'
(0.c5 1 081
M-.)M
o-,p
CoC
0 62
«; :f.-C""8;.
0 48
(0 41 0 ; 7)
0 4;
lO -10 0 . 6)
0 83
iO.43-0.c9i
0 20
lO 07 0 581
0 3;
(0 63 1 19;
Ot-ie son:
i 06
n • 98-1 i'1;
1 02
(0.91 1.14)
03I
0 '-''Si
i0 • 1
0 96
i,0 39- I 04;
0 6c
IO 88 1 12;
1 2c
(U 96 i 64)
l.cl
l l 42-i 61;
1.99
(1 34 2 17;
I 1;
{1 04 1 32;
1.50
•I -lO-l 60t
I 4.'
|1 01 2 12)
I ;0
l l 3L 2 15)
1 93
•J 32-2 0;:)
3.33
(3 17 3,60:
1 .!>;:
•'I 39 I.,-2)
•ll 76-2.00:
2 94
i2 19 3'--;,
2 13
i 1 76 2 69)
2.19
•2 07-2.32:
5.24
•4,97 5.52.1
1.36
'i.68 2.0;:
2.20
• 2 06-2 341
4.1,
{8 Or- 5 621
2.68
(2 14 3 21)
2.50
2.92
•2.3- -2.6c)
•2.110.66
1-8.11)
.' .6c
•7.30 8.02: 40.16
•
•,i.3c 2.-101
2.53
(2.11-2. 6)
.'.3..;.9 X'K'•;
8.31
•2 :2 4.02)
4 1.16)
2.10
{2.16 2.66)
2.96
:2.71-3.i9i
:.;' 7 ' 2''''.'
•1.08
•'3.3c 4.36:
7v??w vv, (,vyty,-v2 YM'f'SfXfy^Cvf- y{v%
iXrMAAAyW///MAyAAA////AA/A^
MoP
OoP
0 18
10 1 l-l, 30)
0.1 1
(0 04 -(j 28)
0 3-'
021
in. 11 -0 48)
C-l
m
3
9
o
o
©
©
0 68
0 96;
1.18
'-• 1 -1 4, ',i
1 01
'.0 .7 1-1.18)
1,42
I ! ' "• i ,"' '1 •
i 6'i
1 18-2.10)
-' -"/
OMe fv.ns.i B'
o
0 81
M
S
bd
Ir1
•t-1
•ic:ud Mi. the 38 -.Mtii uii'-'jn. f x.-'tcn I: :!.rmu i.'jrfco.
H
-J
U>
en
C3
©
~i
©
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W/A
W/,
3.21
-3.131
13.01
3.80
,3.13-1.1 1:
16.66
1.30
;3.82-1.81)
I;.66
2.66
'2.33 2.3,'l
3.41
3.12-3.;2i
2.83
(2.66 3.251
3.85
(3.10-1.2.')
3.03
12 66 3.-16)
4.08
;3::9-1.P1i
Figure 3.2
Comparison of cumulative hazard of first revision for cemented hips with different bearing surfaces
(with 95% CI).
35
30
25
20
15
10
xgSKKKS^^
3
4
5
6
Years since primary surgery
Numbers at risk
Cemented MoP
178,077
152,981
130,206
108,931
88,203
67,448
47,008
30,708
16,134
Cemented MoM
1,229
1,151
1,072
1,002
880
612
397
216
96
15
Cemented CoP
17,202
14,022
11,325
8,961
6,984
5,172
3,652
2,319
1,164
344
5,594
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DEMO-00085-00133
Figure 3,3
Comparison of cumulative hazard of first hip revision for uncemented hips with different bearing surfaces
(with 95% CI).
25
-
20
15
.1 10
3
O
H
5
3
4
5
6
Years since primary surgery
Numbers at risk
ii
——~ Uncemented MoP
74,762
60,095
47,032
34,874
24,669
16,385
10,371
6,010
2,689
Uncemented MoM
28,367
27,716
26,841
24,022
18,424
11,517
5,880
2,476
648
142
Uncemented CoP
27,964
22,234
17,670
13,639
10,443
7,877
5,538
3,617
1,832
602
445
670
Uncemented CoC
67,922
53,029
38,276
25,689
16,673
10,147
5,918
3,134
1,512
— — Uncemented CoM
2,017
1,942
1,621
921
310
53
10
1
1
o
Resurfacing
35,470
33,989
31,820
28,841
24,276
18,459
12,547
7,759
3,881
1,273
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DEMO-00085-00134
Figure 3.4
Comparison of cumulative hazard of a first hip revision for hybrid (not including reverse hybrid) hips with
different bearing surfaces (with 95% Ci).
20
oo
15 -
X
S2
S3
3 10
O
0 3
4
5
6
Years since primary surgery
Numbers at risk
Hybrid MoP
55,585
45,908
37,004
29.075
21,909
15.596
10.122
6.095
2,957
Hybrid MoM
2,297
2,247
2,145
1,951
1.627
1,073
610
338
190
79
•••••••• Hybrid CoP
9,72.0
7,357
5,673
4,295
3,092
2,189
1,559
993
548
187
Hybrid GoC
15,239
13,020
10,672
8,584
6,592
4,802
3,104
1,690
671
163
911
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DEMO-00085-00135
.5„ L, O
Revisions for different causes after primary hip surgery
Methodological note
The previous section looked at revisions for any
reason. A number of reasons may be associated
with any revision; for example, pain and osteolysis.
This means the reasons are not mutually exclusive
and therefore cannot be regarded as representing
'competing risks'. Here we have calculated
incidence rates for each reason using patientTable 3.8 shows the revision rates for each case, for
all cases and broken down by fixation and, within each
fixation group, by bearing surface. In the initial years
of the formation of the registry, adverse soft tissue
reaction was not included in the clinical assessment
forms. Therefore, there were fewer 'patient-years at
risk' for this reason.
The main reasons for revision were pain and aseptic
loosening; resurfacing seemed to have the highest
incidence of each, with uncemented hips a close
time incidence rates (PTIRs); the total number of
revisions for that reason has been divided by the
total of the individual patient-years at risk. The
figures shown are the numbers per 1,000 years at
risk. This method is appropriate if the hazard rate
(the rate at which revisions occur in the unrevised
cases} remains constant. The latter is explored
further later in this section.
contender. Resurfacings also appeared to have the
highest incidence of adverse soft tissue reactions. The
incidence of dislocation/subluxation, however, was
lowest for resurfacings.
After further subdivision by bearing surface, amongst
the cemented, uncemented and hybrid fixation
groups, the metal-on-metal sub-groups had the
highest incidences of pain and aseptic loosening
and also appeared to have the highest incidences of
adverse soft tissue reactions.
^ D wWA'.njrcerttr'&,org.u!i
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177
DEMO-00085-00136
Table 3.8 Revision rates (95% Ci), expressed as number of revisions per 1,000 patient-years, for each recorded
reason for first hip revision. Rates s h o w n are for all revised cases and by fixation and bearing surface.
0/5
•0/0-0.ftO'i
0.32
{0 88-0.001
IO.72-0.841
ip.Hfi-1,00l
(0. In-0.2I)
{0.27-0.881
(0.0M).07:
I
PIG
•2.79-6.11}
C.03
{0.3-'-1.99)
1.16
(0.55-2/3!
4.13
i2.79-6.il)
1.65
-0.89-3.07}
1.16
(0.55-2.43!
0.83
(0.8'-2.00;
cor
82/
0/3
•0.30-0 63}
0.69
{0.51-0.03:
0.87
1066-1.13!
0.67
i0.50-0.01l
0. i I
(0.05-0.2'')
0.10
{CO'-0.21)
0.08
{0.02-0.15;
O.-'iGS.C "Sbic
20.3
0.62
(0.36-1.0/
0.62
{0.86-1.07;
0.96
I.0.62-I/8:
0.91
(O.o8-l/3j
0.!-'
(0.06-0.in)
0.3-'
{0.16-0.70)
0.2''
(0.10-0.56;
MoP
239.6
0.89
(0 70-1.021
1.58
•1.30-1.70}
0.20
;0.15-0.27}
1.01
i0.09-1.15)
0.12
{0.00-0.17:
MoM
132.1
5.82
/.9i-5.78}
1. 10
{098-1,29!
1.60
(1/0-1.88!
8.-14
(8.14-8.7/i
0.82
{0.66-0.89}
0.6-1
{0.81-0.79;
0. If=
{0.10-0.21;
CcP
97 9
0.76
i0.6i-0.96}
1.20
{100-1.41;
07/
{0.80-0.821
1.44
i1.22-l.,0i
0.16
-0.10-0.27}
0.5 i
{0.89-0.68;
0.1-'
{0.09-0.21;
OoG
188.2
1.10
•0.96-1.26}
1.95
(0.92-1.21;
0.80
(0.68-0.94!
1.64
(1/6-1.88!
0.13
-0.09-0. i9}
0.63
(0.71-0.97;
0.63
{0.58-0.76;
GoM
5.9
2.37
! 1 / C - i . oo)
1.19
{0.57-2.49:
1.52
10.79-2.93l
2./1
11.65-<V2i
0.68
'0.25-1.00)
0.;H
{0.08-1.35;
0.17
{0.02-1.20;
O.-'io&G'sure
17.
1/0
(0.95-2.0/
1.31
{0.90-2.00;
0.56
iO.80-t.O4;
2.13
{1.85-2.931
0.80
(0.26-0.97)
1.16
{0.77-1.80;
0.89
{0.19-0,82;
0.68
{0.57-0.80;
0 09
{0.06-0.15:
1.66
{106-2.60;
0 17
{0.01-0.70;
MoM
ft
MoM
11 ''
GoP
30 6
Gr;G
OT-ie-'s/.PSi.re
{3/6-6.96!
{120-2.82!
iO.n3-l.74i
2.97
(2.12-i.lRi
1/9
{0.92-2.39}
0.62
0.98
0.61)
0.52
0.18
0/6
0.03
•0/0-0.97)
{069-1.40!
(0/2-1.01;
(0.32-0.86!
(O.On-O.On)
{0 27-0.77!
(0.006-0.23!
56 9
0.69
{0.50-0.9-')
0.65
{0.4 7-0.90;
0.55
(.0.38-0.78;
0.S5
(0.-'7-0.901
0.11
!0.06-8.23)
C/7
{0.33-0.69;
0.25
{0.15-0.42;
8 2
1.81
•'0.7''-2/1!
0.86
-'0.41-1.78;
1.31
(0.74-2/1!
0.85
10/1-1.78!
0/9
(0.18-1.29!
0/9
-'0.18-1.29;
'"'
Continued >
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w
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DEMO-00085-00137
Table 3.8 (continued)
MoP
MoM
Or.P
20
0.10
i.o.Ofi-0. I:VI
t.ifi
(0.55-2.43)
C.1'1
(0.08-0.28)
0.10
i0.02-0.38)
o n-3
(0.02-0.04!
0.1/
(0.02-1.20!
0.02
10.002-0.1 1)
0.28
(0.24-0.82!
0.33
(0 08- i .32!
0.22
10.13-0.88!
0.2.4
(0.10-0.58!
0 1/
(0.14-0.201
2 0/
;l.8/-4./2)
0 V
10.08-0.28;
0 24
(0.10-0.58!
0.02
lO.OI-O.On)
1.6
3.I0
,1.80-/40)
0
liicuciiiKj II!;•.«'; •.villi uiikiio.vii fx.ilicLiilc.iriiC;. "R-;:;:nl on e s i ; ;.i C.IM in si/o in=(!.v, I h o c l o r e us! ir ;.:;;s .ire • Nireioke. ' " T l i - . rc:= IL=;>II -.V.IS no! ;;sK::i n I n c i d
v..r;:ctns' : )l l i u : : ; m:.-l .-,v:c;su":iil f;>n-is MD1W1 .in.I VDSv? lor m i l re i:>i::;.i"!.iil ro>. ' I o n suruorv -,118 IK.IK.;,. I •!' 11 ii-s re-.son. III. re ;-.r;' l e v e r i:;-.l cnl- v e . r s - l re'k.
^
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DEMO-00085-00138
Table 3.9 illustrates how the risk of revision (for any
reason) changed with time from primary operation.
Note the maximum follow-up for any implant was
9,75 years.
The number of revisions per 1,000 patient-years
was calculated for different periods after the primary
operation, within the first year from primary operation,
and between 1-3, 3-5, 5-7 and 7+ years after surgery.
The rate was higher initially, with a small decrease
between one and three years, after which the rate
began to rise. The rates were less reliable after seven
years because there were fewer patient-years at risk.
Table 3.9 Revision rates, expressed as numbers per 1,000 patient-years, for any reason, according to time interval
from primary operation.
7.71 (7.47-7.96)
&
_
to
4.60 14.46-4.751 '5>
Q
o.ol Ip.30-5.r2j
^
6.36(6.04-6.69) -%
5.75 (5.23-6.32)
'current maximum observed follow up is 9.75 years
In Table 3.10 the breakdown of Table 3.9 has been
repeated, this time showing separate breakdowns
for each reason. There were trends of increasing
risk of pain and aseptic loosening with time. Risk of
§
zto
subluxation/dislocation, infection and periprosthetic
fracture were highest early on, then fell. Incidence
of adverse soft tissue reaction seemed to increase
with time.
Table 3.10 Revision rates (95% CI), expressed as numbers per 1.000 patient-years, for each reason, by time
interval from primary operation.
<1 year
497.6
1 -3 years
756.8
3-5 years
469.0
5-7 years
227.8
years'"
0.85
lO.77-0.94i
2.32
(2.19-2.45)
1.28
(1.18-1.38)
1.28
11.18-1.38)
0.10
(0.07-0.13)
1.49
(1.38-1.60)
0.27
(0.22-0.31)
1.25
(1.17-1.33)
1.77
(1.66-1.90)
1.96
(1.79-2.15)
1.72
11.44-2.04)
0.66
(0.61-0.72)
0.55
(0.48-0.62)
0.58
(0.48-0.68)
0.75
(0.57-0.97)
0,87
(0.80-0,93)
0.58
(0.51-0.65)
0.44
(0.36-0.53)
0.39
(0.27-0.56)
1.38
(1.30-1.47)
1.48
(1.38-1.60)
1.75
(1.59-1.93)
1.88
(1.59-2.211
0.21
(0,18-0.25)
0.40
(0.34-0.16)
0.56
(0.47-0.66)
0.84
(0.65-1.07)
0.29
(0,26-0.83)
0.39
(0.34-0.46)
0.54
(0.46-0.65)
0.48
(0.35-0.66)
0.14
(0.12-0.17)
0.12
(0.09-0.16)
0.17
(0.12-0.23)
0.15
(0.08-0.26)
Continued >
w
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18Q
DEMO-00085-00139
Table 3.10 (continued)
I
<l
y° ar
497.6
^
l -3 voars
756.8
r
c
469.0
76 3-5 years
227.8
^
5-7 years
>7 years"'
0.26
(0.22-0.31)
0.16
(0.13-0 19)
0.36
(0.31-0.421
0.51
(0.42-0.61)
0.52
(0.38-0.711
0.12
(0.10-0.16)
0.05
(0.03-0.07)
0.03
(0.01-0.05)
0.03
(0.01-0.06)
0.04
(0.01-0.121
0.91
(0.83-0.99)
0.40
(0.36-0.45)
0.35
(0.30-0.41)
0.31
(0.25-0.39)
0.39
(0.27-0.56)
0.81
(0.74-0.90)
0.57
(0.52-0.63)
0.69
(0.62-0.77)
0.61
(0.52-0.73)
0.48
(0.35-0.661
301.0
376.3
1 16.2
3.4
0.6
0.10
(0.07-0.15)
0.71
(0.63-0.80)
2.04
(1.80-2,32)
2.36
(1.18-4.72)
1.80
(0.25-1.30)
'Includes the 38 with unknown fixation/bearing. "Tins reason was not asked In the early versions of theciinicai assessment forms MDSvl and MDSv2 for joint
repacement/revision surgery and hence, for these reasons, there are fewer patient-years al risk. '"Current maximum observed follow up is 9.75 years.
Note on dislocations/subluxation: There were 2097 first revisions performed where dislocatons/subluxation was given as a reason (out of all 539,372 operations); in
1,361 of these (64.9%) dislocation/subluxation was the only given reason. From tables 3.9-3.10 above, revisions due to dislocation/subluxation were more common
in uncemented and hybrid/reverse hybrid hips than cemented hips and were more common within the first year after primary operation.
3,2,4 Revisions after primary hip
surgery far the main stern-cup
brand combinations
Table 3.11 show Kaplan-Meier estimates of the
cumulative percentage probability of revision (for any
reason) for the main stem-cup brands.
As in our previous reports, we have only included
those stem-cup combinations with more than 2,500
procedures in the case of cemented, uncemented,
hybrid and reverse hybrid hips, and more than 1,000
in the case of resurfacings.
^ D
^w * 1
The figures in italics were at time points where, fewer
than 100 cases remained at risk.
Note it is possible that these sub-groups may differ in
composition with respect to other factors that might
influence revision, such as age and gender; no attempt
here has been made to adjust for such factors.
Some further subdivisions by bearing type, however, are
shown in the table that immediately follows, Tabie 3.12.
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DEMO-00085-00140
Table 3.11 Kaplan-Meier estimates of the cumulative percentage probability of first revision (96% CI) at different
times after the primary operation, for cup-stem brand combinations with large group sizes (>2,500 or > 1,000 in the
ease of resurfacing?.). .8/ue • <///'>; / / / c a f e th:~A rower mar- !0fj rases remmo % /;%.
O-aooy
Ge-me-ireci
Slo-rv
G-arcyOgce
9,099
0.37
10.20-0.;>2l
0.82
10.07-'.00
( 0 . 9 7 - ' .4 "I
;1.22-1 .7:J)
('.561-2.17i
11.84-2.54)
(2/2-2.9'i
12/8-3.151
12.00-8.781
0.20 0.4-)
10 .55 0.76]
10.fie ' .0" I
(0.8:3 1.27)
.'A'.
0')
'.0-1
11.38 1.9c'!
'.88
r .59 2.23)
2.88
( ' . 9 6 2.751
2.''9
(2.09 2.931
0/-'
10.27 0 . 7 3 |
0.70
i O / 7 1 (K)
0.90
' .29!
'.07
10.76 1/9)
'.'7
(0.34 '.621
'.28
lO.93 1.77)
('
1' .38 2 . 8 ' I
1-.3B 2 . 8 ' I
0.38
0,58
0.98
'.10
Cairoy
CC'TC-lLOd
S1eiv
10,307
Concawd
G.,p
G-S.OTI
Cere-r.ff.i-'
E.cP.sOgco
Sta-mn-e
Mod..;IO- S.OTi-'
Stamno-eAcoTiG..p
'/5
.161
" .6"
1.61
•0.23 0.03) 10.38 0.89) ;0.69'.38l 10.79 1.53) (-.05 ',98) (1.17-2.21)
0.09
0.53-0.00]
_,
0.5-3
"
(0.38-0-19)
(0.613-0.78)
(0.22 0.39]
(0 ••' 1 0.G3)
1.22
0.99-'.5']
0.93
(0 85-'.03]
0.75(0 C 0.89]
0.58
10.b-0.73i
0.9"
(0.761-1.OH)
1.20
(".02-'.-12)
11.80-1.761)
(1 5 1 - 2 . 0 ' ]
11.84-2/4)
(2.22-2.94)
12.6' -3.67 n
3.23
12./3-3.82)
ExerA-VrO/
E.oP.-s
Gc-TiC'i.cd
(0.29
;0.50
(0 05 ' . ' Si
10.71 1.28)
(0.74
'.331
10.83 I.5GJ
(0.95
( ' . 0 3 2. G]
('.03 2.'0]
0.-P
D.clc- V7Q:
Exeter R nrr:
0.G7
(0.42-/051
0.9'
(0.55-1.51)
0.55
(0.24 o.79i
0.54
(0.31 0.92)
0.75
( 0 / 5 ".25)
0.92
10.57 1/9)
'.'2
(0.70 '.781
'/2
10.70 1.781
GPT/2CA
CXGLOV-O/
_
Gorts-Tiporary
Cxcic- VrO/
E :eP..sOgai
T r
""
Excic VrO/
ExeieDi/nlon
0 65]
0.91
;n.7-'-1
•2.2 ' I
(
0.95j
'.50
(1.22-1.8/
".-4
;i.O-'-i.26i)
0.86
10.72 1.03)
'.92
i'.58-2.88,i
• 39
.52;
I
-.05
(0.87 '.24;
2.3"
(1.90-2 81)
' 65
(1.51-1.82)
-.3'
11.11 1 5Gj
2.73
(2.22-3.301
" .1/
(' 6>5-2.03j
-.50
C.2G'.79)
2.88
(2.8'-8.58i
2.11
('.88-2.37)
1.57
('.30'.90]
2.88
(2.3'-8.581
2.30
(\99-2.Gp
1.57
90]
'.851
O-S.C-TIAMT
GeneT.ed
E.oP-,3
(Demented
Cup
Aeonade
Gorai .-P -vndo
Gorai /ASR
Ros./iTC/g
G-p
micrg I IAG
w i.'GSr
6 ,-,72
2
iA
10.77 ".08] 11.12 1.50
Continued
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182
DEMO-00085-00141
Table 3.11 (continued)
F.rto^g HAG
SinivOSr
1 ' ,39'
PuS
(0.92 - . 3 ' I
(1.32 181)
r 46 -.691
;1.63 2.21)
r .63 247
(0.97-'.67!
;'.78-2.701
2.8C
(2.37-3.Gil
(2.83-40'i
!;-i.;iH-S.0-')
(3,92-3.00)
-.16
(0.95-' .89)
1.44
(-.2--1.73i
'.7l'i
!' .-12-2.00
1.93
C.59-2.81i
244
!'.«5-2.90i
2.72
(2.06-3.691
SL-PLs
Gc-ricn.css
SteTv'EP/Frt
•l.'KG
/9
4.15 0.76I
PLS
Taoe-'cc
Go non.oss
Sin TICLxfOfil
ACT
9,893
GPT/Ticyv
8,987
Dcoto'V^V
Pi-sacc
Exoio V40-'
5j
Trce-i.
CO
c
T.
Tr logy
2,803
28,367
0.83
I'O.GG '.05)
I."
-.21
1.62
(0.90 1.371
(0.99 ' / 9 i
{'.33 1.971
(1.85
2.26
248
2.75)
(2.0i 3 . 0 / i
i2.'0
2.63
3.04
3.29)
(2.'-J '21)
048
0,79
'.02
173
-29
1.68
.'.64
; 64
(0.27 0.85)
(0.50 1.26)
(0.66 '.59i
(0.73 1,75,i
(0.82 2.03)
(0,95 2.98)
;5 55 2.94;
4 05 7 5G
0.59
0.90
.09
(0.5' 0.09)
(0.79 1.03)
(0.90 '.2G
1.2-5
(MOLI'i
'48
1.73
2.06
2.31
C.30'.G7)
(1.5' '.97)
C.75242I
i1.9'2.80)
0 57
0.80
'.02
1.20
(.38
1,6'1
'.80
2.12
2.30
(0410.73)
(O.G'' 1.00)
(0.83 '.25i
(0.98 i .45)
( ' . ' 3 '.07)
(1.35 ' .99)
(".47 2.20i
(1.GG2.71)
(1.75 3 01)
3-0.931
(0.60-421
(0.85 1.36)
4 . ( 4 2.2'I
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The cemented, uncemented and hybrid stem-cup
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in the preceding tabie (Tabie 3.11} have been further
divided by bearing surface.
42
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percentage probabilities for the resulting fixation/
bearing sub-groups in which there were more than
1,000 procedures.
^fllll) wwA'.njrcentr'&,org.uli
JEWELL 183
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00142
Table 3.12 Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) at different
times after the primary operation for cup-stem brand combinations with large group sizes (> 10,000) with further
subdivision by main bearing surface (provided the sub-group size >1,000). Bias italics indicate thai iewer than 100
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www, nj roe n tre ,o rg „ uk
^IS^
143
JEWELL 184
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00143
3.2.5 Revisions after primary hip
surgery: Effect of head sizes for
polyethylene liners
Four sub-groups were identified with polyethylene liners,
I
metal-on-polyethylene monobloc-cup (n=185,027)
F, (metal-on-polyethylene - metal shell with
polyethylene liners (n=T29,152)
SJL ceramic-on-polyethylene - polyethylene
monobloc-cup (n-20,841)
iv, eeramio-on-polyethylene - metal shell
with polyethylene liners (n=37,278)
The Graphs (i)-(iv) in Figure 3.5 show the respective
cumulative hazards broken down by head size. The
same scale has been used for all graphs to facilitate
comparison between them. Only head sizes where
there were more than 500 procedures are shown.
A Cox 'proportional hazards' regression analysis was
performed to compare the head sizes in each case,
The most frequently used head size, 28mm, was used
as the baseline for comparison in each analysis.
In the case of (i), metal-on-polyethylene monobloccup, there were significant differences between the
five head sizes shown (P<0.001). Rates of revision for
22.25mm head size did not differ significantly from
the baseline of 28mm heads (Hazard rate ratio (HRR)
1.05 (95% CI 0.95-1.17) P=0.31). Revision rates for
26mm heads were significantly lower (0.80 (0.690.93} P=0.003) than for 28mm heads and rates for
both 32mm and 36mm were higher (1.19 (1.02-1.40)
P=0.031 &2.08 (1.27-3.41) P=0.004, respectively).
For (ii) metal-on-polyethylene with metal shell/
polyethylene liner, the differences between the head
sizes were not significant overall (P=0.055), however
the revision rates were higher for 44mm heads than
the baseline 28mm heads (HRR 1.84, 95% CI 1.172.90, P=0.008) whereas other head sizes did not differ
significantly (minimum P=0.14).
For the other groups, (iii) and (iv), there were no
significant differences amongst the sets of head sizes
shown (P=0.69, P=0.15, respectively), although there
were too few cases for larger head sizes to make
worthwhile comparisons,
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
185
DEMO-00085-00144
Figure 3.5
(i) Comparison of the cumulative hazard for revision for different head sizes for metai-on-polyethylene.
monobloc cup. (NB only head sizes where n>500 are shown)
5 -
3
2
o
3
4
5
6
Years since primary surgery
Numbers at risk
Head size 22.5mm
29,582
27,420
25,021
22,410
19,585
16,573
13,107
9,701
5,922
Head size 26mm
16,642
15,416
14,049
12,742
10,951
8,990
6,943
4,945
2,772
965
Head size 28mm
120,152
103,028
86,715
71,059
55,970
40,629
26,182
15,606
7,224
2,260
Head size 32 mm
16,784
11,586
7,925
5,258
3,317
2,056
1,172
639
291
78
Head size 36mm
1,331
746
393
165
30
3
Q
0
0
0
2,312
ww w, nj rce n tre.org„ uk
W
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
186
DEMO-00085-00145
Flqure 3J
(ii) Comparison of the cumulative hazard for revision for different head sizes for metal-on-polyethylene with
metal shell/polyethylene liners. (NB only head sizes where n>500 are shown)
6
(fi
N
10
3
cp
•>
2
o
3
4
5
6
Years since primary surgery
Numbers at risk
^ D
^w * 1
Head size 22.5mm
850
722
608
527
474
404
333
239
139
Head size 26mm
737
680
615
534
464
386
298
208
108
23
Head size 28mm
68,789
60,999
52,854
44,150
35,350
26,202
17,662
10,739
5,039
1,462
Head size 32mm
32.691
23,357
16,037
10,190
5,840
3,051
1,512
614
219
20
Head size 36mm
22,394
16,227
10,769
6.272
2,997
1,317
476
171
66
14
Head size 40mm
2,928
2,462
1,923
1,382
838
286
25
10
5
1
Head size 44mm
698
571
452
320
193
58
2
1
1
0
45
wwA'.njrcentr'&,org.u!i
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
187
DEMO-00085-00146
Hqure 3,5
(iii) Comparison of the cumulative hazard for revision for different head sizes for eeramic-on-polyethylene with
polyethyiene monobloc cup. (NB only head sizes where n>50Q are shown)
3
4
5
6
Years since primary surgery
Numbers at risk
. „ „ „ „ Head size 22,25mm
2,314
2,082
1,814
1,599
1,376
1,104
801
485
190
0
Head size 28mm
15,115
12,558
10,310
8,134
6.259
4,506
3,040
1,958
1,032
364
..,.„„„ Head size 32mm
3,073
2,074
1,339
829
447
210
120
62
23
9
www, nj rce n ire.org „ ok
W
147
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
188
DEMO-00085-00147
Fiqure 3,5
(iv) Comparison of the cumulative hazard for revision for different head sizes for ceramic-on-polyethylene with
metal shell/polyethylene liners. (NB only head sizes where n>500 are shown)
6 -
3
4
5
6
Years since primary surgery
Numbers at risk
Head size 28mm
18.790
16,743
14,724
12,686
10,569
8,443
6,161
4,125
2,199
748
Head size 32mm
, . „„
u
11.265
8,077
5,591
3,497
2,096
1,184
725
406
151
37
6,883
4,229
2,657
1,524
711
313
120
21
0
0
3.2,6 M o rta lity arte r p ri m a.ry
hip surgery
This section describes the mortality of the cohort up
to nine years from primary operation, according to
gender and age group. Deaths were updated at the
end of February 2013 using data from the Patient
Demographic Service. Two hundred cases were
excluded because the NHS number was not traceable
and therefore no death date could be ascertained. A
further three were excluded because of uncertainty in
gender (n=1) and age (n=2), leaving 539,169, with a
total of 42,805 reported deaths. Amongst these were
3,091 bilateral operations, with the left and right side
operated on the same day; here the second of the two
has been excluded, leaving 536,078 procedures and
42,655 deaths.
^ D
^w * 1
Table 3.13 shows Kaplan-Meier estimates of
cumulative percentage mortality at 30 days, 90 days
and at each anniversary up to the ninth, for all cases
and by age and gender.
Note the cases were not 'censored' when further
revision surgery was undertaken. Such surgery may
have contributed to the overall mortality as shown
here. The impact of this has not been quantified.
wwA'.njrcentr'&,org.uii
JEWELL 18 9
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00148
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(3 88-4.96;
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(6.27-7 36;
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5.85-6.60;
3.94
8.81
3.23-9.44;
10.22
(9.42-11.no;
4.78
16.88-7.78,
11.29
11.08
16.52
0.77-11.84, (13.34-14.76; (15.58-17.52]
8.4 1
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Smith AJ, Dieppe P, Howard PW, Blom AW; National
Joint Registry for England and Wales. Failure rates of
metal-on-metal hip resurfacings: Analysis of data from
the National Joint Registry for England, and Wales.
Lancet. 2012 Nov 17;38Q(9855):1759-66
There were substantial differences between the bearing
groups in terms of patient characteristics. To reduce the
effects of confounding, analysis was based on the large
majority with an American Society of Anaesthesiologists
(ASA) grade of 1 or 2 at time of primary surgery and
those whose surgery was undertaken for osteoarthritis
only (Table 1). The now-withdrawn ASR implants
(2,829, 8.9% of the total) were excluded from the
resurfacing analysis so as not to distort the results.
Furthermore, sensitivity analysis confirmed that the
results for the newer technologies of resurfacing and
ceramic-on-ceramic were not distorted by a 'learning
curve' effect of less experienced surgeons (see web
appendix published in Lancet).
We have analysed data from the NJR to test the
following hypotheses: larger head size is related to
higher failure rates; metal-on-metai has significantly
worse results in women; and hip resurfacing gives
better implant survivorship than stemmed THR in
younger patients.
Multivariate analysis has been used to adjust for
patient age and ASA grade and to measure the effect
of head size. As head size and gender were highly
correlated, separate models were estimated for men
and women to avoid multicollinearity. Separate models
were also specified for the different bearing groups.
Methods
Flexible parametric survival models that estimate the
cumulative incidence of revision in the presence of the
competing risk of death were used. Standard survival
analysis treats death simply as censored information
but this has been shown to overestimate revision
rates. In all models, head size, age and ASA grade
were selected as predictors of revision and age and
ASA grade were predictors of the competing risk of
death. The effect of age was allowed to differ for the
main and competing risks. These models produce
hazard ratios, which are a measure of relative risk
(averaged over time). To illustrate the absolute effect of
these factors, the models have been used to predict
revision rates for a typical patient by estimating the
covariate-adjusted cumulative incidence function in the
presence of competing risks.
3.2.7 In-depth study: MetaL-on-metal
hip resurfacing
Since the last annual report we have examined metalon-metal hip resurfacing in greater depth. A research
paper comparing the failure rates of metal-on-metal hip
resurfacings with alternative forms of hip replacement
was published in the Lancet in November 2012.
Analysis was based on 434,560 THRs between April
2003 and September 2011 where patient-identifiers
are present that allow revisions to be linked to primary
operations (81.8% of 531,247 operations). These
operations were performed in 447 units under the care
of 2,584 consultant surgeons.
The analysis estimated all-cause revision rates. The
unit of analysis was implant (rather than patient) so
bilateral procedures were included (2,645). We have
compared revision rates for three types of bearing
surface: resurfacing, ceramic-on-ceramic, and metalon-polyethylene. A range of commonly used head
sizes were compared for the resurfacing and ceramicon-ceramic groups whereas the most commonly used
head size of 28mm (Table 1) was been chosen for the
metal-on-polyethylene group. A confounding variable
was the fixation of the implant. We have addressed
this by reporting ceramic-on-ceramic results for
uncemented fixation as this was most commonly
used (45,099/57,748, 78.1%) while for metal-onpolyethylene, results were shown separately for
cemented, uncemented and hybrid fixations.
One resurfacing brand, the Birmingham Hip
Resurfacing system (BHR), was used in more than
half of cases giving large enough numbers to repeat
the multivariable analysis approach for the BHR cases
alone (15,386/26,199, 58.9%). This enabled the
potentially confounding influence of different brand
effects to be removed. We have compared the BHR
with the most commonly used alternatives in each
group: the Exeter V40 Contemporary metal-on-
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
polyethylene 28mm cemented THR (23,906/69,569,
34.4%) and the Corail Pinnacle 36mm ceramic-onceramic uncemented THR (9,604/18,370, 52.3%).
The reasons for revision across all groups were also
examined by dividing the number of revisions for each
reason by the total person time at risk of revision (per
1,000 patient-years). This was equivalent to a persontime incidence rate and 95% confidence intervals have
been estimated assuming a Poisson distribution.
Results
Overall, 7.4% (31,932/434,560) of THRs were
resurfacing procedures. Annual numbers in England
and Wales reached a peak of 6,650 operations in
2007 but thereafter fell to around 2,000 in 2011.
Resurfacing patients were most commonly aged 59
years while the median age was 55. Overall, 78.4%
of patients were aged 45-65 years and 69.1 % of
resurfacings were undertaken on men (Table L1),
Unadjusted analysis suggested that revision rates for
resurfacing procedures were higher than for stemmed
THR (five-year revision rate of 5.2% (95% CI 4.9-5.5%)
compared with 2.8% (95% CI 2.7-2.9%). However,
this overall rate disguised differences according to
gender (Figure L1). In women, 8.5?/o of resurfacings
had been revised by five years (95% CI 7.8-9.2%)
compared with 3.6% in men (95% CI 3.3-3.9%). A
head size of between 46mm and 54mm was used for
92.1% (20342/22076) of male resurfacing patients
while 76.5% (7541/9856) of females had a head size
of 42-46mrn. Just 1 % (98/9,856) of women received
the larger head sizes above 50mm. In total, 15
resurfacing brands were used.
The multivariable models for resurfacing procedures
confirmed that head size was an independent
predictor of revision for both men (hazard ratio 0.951,
95% CI 0.945-0.978, p<0.0005 per unit increase
in head size) and women (hazard ratio 0.921, 95%
C! 0.892-0.951, p<0.0005) indicating that smaller
head sizes were more likely to be revised. These
hazard ratios can be broadly interpreted as each
1 mm increase in head size being associated with a
5-8% reduction in the hazard (the risk of revision at a
particular point in time). Age was a significant predictor
of the competing risk of death but not of revision for
either men or women. ASA grade was a significant
predictor of revision for men only (hazard ratio 1.267,
95% C11.042-1.540, p=0.018) indicating that patients
with ASA grade 2 were more likely to be revised than
those with ASA grade 1.
Predicted revision rates from these models illustrate
the absolute effect of head size. For a 55-year-old
man, the five-year revision rate with a 46mm head was
4 . 1 % compared with 2.6% for a 54mm head (Table
L2). Resurfacing revision rates for women were much
higher than for men (five-year revision rate of 8.3%
with a 42mm head size) (Table L3). This was true even
with the same head size: a 55-year-old woman had
a five-year revision rate of 6.1% with a 46mm head
size compared with 4.1 % for a 55-year-old man. Only
0.4% (35/9,856) of women had a head size of 54mm or
above associated with the lowest revision rates in men.
Resurfacing procedures with a large head size
(54mm or greater) resulted in revision rates which
were not significantly worse than those of other
common surgical options (Table L2). In men, a
54mm resurfacing head had a five-year revision rate
of 2.6% compared with 2.1 % for an uncemented
40mm ceramic-on-ceramic prosthesis and 1.9%
for a cemented 28mm metal-on-polyethylene
articulation. However, the smaller resurfacing head
sizes compared less well. Key results are illustrated
in Figure L2. Overall, just 23% (5,085/22,076) of male
resurfacings used the 54mm or larger head size that
had the lowest revision rates.
In women, resurfacing, even with larger heads, offered
significantly poorer implant survivorship than all other
common surgical options (Table L3), In 55-year-old
women, a 46mm resurfacing procedure had afiveyear
revision rate of 6.1 % compared with 2.5% for a
36mm ceramic-on-ceramic prosthesis and 1.5% for
a cemented 28mm metal-on-polyethylene articulation
(Figure L3).
Generally, the BHR had better implant survivorship
than other resurfacing brands. Unadjusted analysis
for all male patients shows a five-year revision rate of
2.4% (95% CI 2.1-2.7%) for the BHR compared with
8.1 % (95% CI 6.7-9.8%) for the now-withdrawn ASR
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
and 4.2% (95% CI 3.7-4,9%) for other resurfacing
brands. The equivalent five-year revision rates in
women were more than twice as high for all brands
(5.8% (95% CI 5.1 -6.6%) for the BHR, 21.0% (95%
CI 17.7-24.9%) for the ASR and 9.2% (95% CI 8.1 10.5%) for other brands). However, the multivariable
models indicated that in men aged 55, the BHR with
the 54mm head size did not demonstrate better
implant survivorship than the Exeter/Contemporary
or the Coraii/Pinnacle and had considerably worse
implant survivorship in women (Table L4).
Resurfacings were most commonly revised for pain,
periprosthetic fracture, and aseptic loosening (Table
L5). Revision for periprosthetic fracture was up to
eight times more common in resurfacing than in other
surgical options. Revisions for pain in women were
up to 10 times higher with resurfacing than with other
surgical options and revisions for aseptic loosening
were up to four times higher. Revisions for dislocation
in resurfacing were lower than other options in men.
Fiqure LI
Cumulative hazard of revision after resurfacing by gender (with 95% Ci).
14% 12% -
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i
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2
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3
4
5
6
7
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00152
Figure 12
Estimated cumulative incidence of revision for 55-year-old male by prosthesis type.
Resurfacing 46mm
5%
Resurfacing 48mm
4%
Resurfacing 50mm
Resurfacing 52mm
3%
Resurfacing 54mm
~
Uncemented
eeram ic-on-ceramic
40mm
2%
1%
Cemented
metal-on-po lyethy lene
28mm
O
2
3
4
5
Years since primary surgery
Fiaure L3
Estimated cumulative incidence of revision for 55-year-oldfemaleby prosthesis type.
c
12% 11% -
..-••"'
•1 10% S 9% o
o
73
c
Resurfacing 42mm
8% 7% -
...'••""! . ••"'
..• ••""'
Resurfacing 44mm
b?B
Resurfacing 46mm
5% -
Uncemented
ceramic-on-ceramic
36mm
g
4% -
|
3% -
|
?% -
°
1% -
Cemented
metal-on-polyethyiene
0 0
1
2
3
4
5
6
7
Years since primary surgery
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00153
Table L1 Description of comparison groups: number of cases (percentage of total).
[C¥X\4s>^ 7 p^opcc,^
fit and healthy
2 - mild systemic
limit activity
3 - systemic disease that limits activity but
is net incapacitating
4/5 - incapacitating, life-threatening
systemic disease/not expected to survive
24 hours vvhhout an operation
[13.0%)
(69.6%)
(7.6%)
37.764
(16.7%)
(0.2%)
1589
(0.7%)
50,626
7.122
57,748
(87.7%)
(12.3%)
(13.3%)
208.173
17,992
226,165
(92.0%)
(8.0%)
(52.0%)
(81.8%)
(27.0%)
(83.2%)
36,009
1,202
397
(62.4%)
(46.5%)
(88.8%)
115,574
2,144
434
(6.4%)
(10,3%)
(14.2%)
9,034
8,868
6,419
4,577
2,940
1,980
1,182
1,008
(25.1%)
(24 6%)
(17 8%)
(12 7%)
(8 2%)
(5 5%)
(3 3%)
(2 8%)
14,871
16,967
17,257
17,852
16.906
13,218
10,265
8,237
947
(3.0%)
36
(0.1%)
Osteoarthritis only
Other
Total i% ot all THR)
29,550
2,382
31,932
(92.5%)
(7.5%)
(7.4%)
Total in model
Number of surgeons
Number of units
26,119
698
372
Less than 1 year
1 - < 2 years
2 - < 3 years
3 - < 4 years
4 - < 5 years
5 - < 6 years
6 - < 7 years
7 or more years
^1,681
2,692
3,708
4,457
4,335
3,653
2,835
2,756
4,385
1 19
bi.4i.vi :.^vV<ViiVvVbbbbbbbbbbb§S
(17,1%)
(16.6%)
(14,0%)
(10.9%)
(10.6%)
iiiiiiiiii
(51.1%)
(83.0%)
(97.1%)
(HHHH^
(12.9%)
(14.7%)
(14.9%)
(15.4%)
(14.6%)
(11.4%)
(8.9%)
(7.1%)
Note: among the full sample of hip replacements (N=434,560), there are other bearing surfaces which are not sliown in this table: 46,200 ceramic-on-poiyethyiene
(10.7% of the total). 31,171 stemmed metal-on-metal (7.2% of total), 2.430 other combinations (0.6%), and 38,824 unknown bearings (8.9%).
^ f§
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JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
195
DEMO-00085-00154
Table L2 Predicted revision rates for 55-year-old males by prosthesis and head size (95% Ci).
5.23 (4.29-6.38)
4.69 (3.99-5.51)
4.20(8.65-4.84) g
3.77 (3.23-4,38) ^
3.31 (2.80-4.06) "5*
i aUncemented 28mrn
.2'1 (0.92-1.68)
2.46(1.87-3.22)
3.4 1 (2.64-4.40)
Uncemented 32mm
1.05 (0.34-1.30)
2.07(1.72-2.50)
2.88 (2.39-3.47)
Uncemented 36mm
0.88 (0.71-1.10)
1.75(1.43-2.14)
2.43(1.96-3.02)
Uncomontod '10mm
0.74 (0.55-1.01)
1.09-2.00)
2.05(1.49-2.83)
Cemented 28mm
0.56 (0.43-0.73)
28(1.00-1.64)
1.91 i 1.50-2.44)
Hybrid 28mm
1.26(0.83-1.92)
2.19(1.48-3.24)
8.21 ( 2.20-4.67)
Uncemented 28mm
1.4 1 (1.03-1.93)
2.57(1.92-3.42)
8.48(2.63-4.59)
™ 16
4.08(3.14-5.28) ^
3.45(2.81-4.23)
|
2.91 (2.28-3.71)
2/16(1.73-3.47)
1
OSS:
@
IP
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2.40(1.87-3.06)
4.10(2.80-5.97)
4.18(3.14-5.56)
Mote: resu ts are estimated Iron r u t'.-arable compst nc sks flexl.'le paramatrc survva! models based on 18,3 re resurfacing cases. 16.138 uncemented cerar
on-cersiric cases, and for Zomm iretal-on-polvethv ene :2,iu,' cemented, 6.63-- hybrid and 9.332 uncemented cases. Hesuts are based on an ASA grade of:
Table L3 Predicted revision rates for 55-year-oid females by prosthesis and head size (95% CI).
Nolo: rcsuiis --re csl rn-Jeci Iron n ui ..Mr-.he compel ny rsks lcAhc.'P:-.r-,m;,lr<: s'.ir.v.i n net;;; h
ecr-m; <:-,s;,'.. .11 id !or?3mn nela-on-ncyclh;, cue: Z7.1B" cemc.riled. 13,363 hybrid mid 16,631
'A4r,.sui-l-,etig :;.il;.cJ::-,::;.ii. Resul:;
10,373 mice nenk.de, ran c:-o
l:;-.s:;d :>n.111 A„5/\ er--.de: :>(?.
www, nj rce n ire.org, uk
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
196
DEMO-00085-00155
Tabie L4 Comparison of most c o m m o n l y used brands; predicted revision rates for 65-year old patients ( 9 5 % Ci).
BHR 46mm
4.32 [3.26-5.70)
BHR 50mm
3.27 (2.69-3.97)
BHR 54mm
2.4 7 (1.90-3.20)
Unconsented Go-rail /Pinnacle
oerarnic-on-corarnio 36mm
Comontod Exeter V4GV
Contemporary' metal-on polyethylene 28mm
0.93(0.65-1,85)
0.53 (0.28-1.021
t.00 (0.54 -1.86)
1.31 I 0 . 7 1 - 2 . 4 1 I
1.61 (0.86-3.02)
BHR 42mm
2.01 (1.52-2.66)
5.02(1.03-6.25)
8.28 (6.73-10.04)
11.76 (9.59-14.36)
BHR 46mm
1.20 (0.91 -1.57)
3.00(2.43-3.71)
4.96 (4.08-6.00)
7.14 (5.86-8.67)
Unconsented Gorail/Pinnaele
coramic-on -ceramic 36mm
Cemented Exeter V40/
Contemporary melai-onpolyet hylene 28mm
2.00(1.35-2.95)
0.63 (0.42-0.94)
1.53(1.07-2.20)
0.42(0.25-0.71)
0.87 (0.54-1.4 1)
1.38 (0.86-2.20)
1.94 (1.18-3.17)
No!;;: r.'isul:; ;.r;; (.:;! |-;J:;d Iron nu > vorohlo oou • •.•! no rskii fioxho p. iron Hrio ourv vol no<k.:> loond on IC/ifse rio ;.i id -.~9: foroioBi IR rooiiri.ioiio
:>,'«>') n .lo.ind d-.rl.'i fin no Con. Pniiool.; .SiVri onnrlo-on-oornii .• onoo:; ;;nd .'.';.;,' n-io.nui 1f;.!)4D f-.r'oio .o-.'o for liio Fxol-.r.'Gonloripor.iry. Ro;
'<: Sfiriri •:; lh::li.i:; oily h.,;.n n u^o
U ::•::< i ..'ii ; .11 ASA p,rnd; • of ?. So-.'on-y.,or ro'„ ;..m rolon omiioi ho :.-;l nUori for iho Corn I-'Pun. ink: o;rone:-on-:or;.
;-.IK1 Vv.-.ioo oiIOO 9005.
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00156
Table L5 Reasons for revision (95%) CI), expressed as incideno per 1,000 patient-years, by articulation and fixation.
P-¥
^p\\\Pw
0.75 10.58-0.97)
Aseptic loosening
1.-12 11.17-1.72)
1. 80(1.12-2.27)
1.88 11.18-2.41)
0.73 (0.47-1.14)
Dislocation/subtuxation
0.18(0.10-0.31)
1. 13 (0.81-1.52)
1.56 (1.19-2.04)
1.77 (1.32-2.36)
0.75 (0.58-0.97)
Implant failure
0.07(0.03-0.16)
0. 46 (0.29-0.73)
0.35 (0.20-0.62)
0.12(0.04-0.37)
0.10(0.05-0.20.1
Implant fracture
0.29 10.19-0.1-1)
0. 62 (0.11-0.92)
0.08 (0.00-0.21)
0.15 (0.06-0.41)
0.05(0.02-0.18)
Incorrect sizing
0.03i().C)1-0.11)
0. 05 (0.01-0.21)
0.03 [0.00-0.21)
0.00 -
0.00 -
Infection
0.55 (0.10-0.75)
1. 13 (0.81-1.52)
1.12 (0.81-1.54)
1.15 (0.80-1.65)
1.09 (0.88-1.34)
Lysis
0.25(0.16-0.39)
0. 08 (0.02-0.24)
0.29 (0.16-0.55)
0.19(0.08-0.46)
0.24 (0.15-0.37)
Malalignment
0,61 (0.18-0,86)
0. 59 (0.39-0.89)
0.68 10.15-1.02)
0.27 (0.13-0,56)
0.21 i0.13-0.34)
Other
1.12(0.90-1.39)
0. 69 (0.18-1.01)
0.18 (0.08-0.39)
0.31 (0.15-0.61)
0.15 10.09-0.26)
Pain
1.70(1.12-2.02)
1. 13 (0.84-1.52)
1.00 10.72-1.40)
0.77 (0.50-1.19)
0.46 10.34-0.64)
Periprosthetic fracture-
1.54(1.28-1.86)
0. 64 (0.43-0.95)
0.38 (0.22-0.66)
0.69 (0.44-1.10)
0.51 (0.38-0.701
73,113.3
38,917.4
33,959.7
26,061.9
79.971.3
£
255
185
128
267
g>
16.136
9,352
6,634
22,407
0.75 10.68-0.90)
5
CM
Person 1 ime (years)
Number revised
Number of operations
^
18.375
m
DC
Aseptic loosening
3.78 13.14-4.43)
25 (0.97-1.61)
1.17 10.92-1.49)
0.83 (0.61-1.12)
Dislocation/subtuxation
0.77 (0 53-1.13)
09 (0.83-1.42)
1.72 (1.41-2.10)
1.38(1.09-1.75)
0.81 (0.69-0.96)
Implant failure
0.37 (0.22-0.64)
4 1 (0.26-0.64)
0.21 (0.12-0.38)
0.28(0.16-0.47)
0.05 (0.03-0.10)
Implant fracture
0.32 l(). 17-0.57)
66(0.46-0.93)
0.05 10.02-0.17)
0.06 (0.02-0.18)
0.03 (0.01-0.07)
Incorrect sizing
0.09 (0.03-0.27)
12 (0.06-0.27)
0.05 10.02-0.17)
0.02 (0.00-0.14)
0.01 (0.00-0.05)
Infection
0.63 (0.42-0.96)
41 (0.26-0.64)
0.39 (0.26-0.59)
0.32(0,19-0.52)
0.56 (0.46-0.69)
Lysis
0.86 (0.60-1.23)
12 (0 06-0.27)
0.07 (0.03-0.19)
0.18(0.09-0.34)
0 14 (0.10-0.21)
Malalignment
1.15(0.84-1.56)
78(0.57-1.07)
0.82 10.61-1.09)
0.47 (0.32-0.71)
0.30 (0.23-0.39)
Other
2.78 (2.28-3.40)
.74 (0.53- i.02)
0.4 1 (0.27-0.62)
0.18(0.09-0.34)
0.17 (0.12-0.25)
Pain
5.28 (4.57-6.10)
00(0.76-1.33)
0.68 (0.49-0.93)
0.51 (0.35-0.75)
0.41 (0.33-0.52)
1.61 (1 24-2.09)
94 (0.71-1.26)
0.55 [0.39-0.78)
0.32 (0.19-0.52)
0.19 (0.14-0.27)
34,859.4
48,806.1
56,259.4
50,637.5
167.174.5
477
274
248
167
7,744
19,873
16,636
13,383
Periprosthetic fracture
Person time (years)
Number revised
Number of operations
p
41 1
47,162
Not including reverse hybrid
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157
198
DEMO-00085-00157
3,2,8 Conclusions
This year's report confirms many of the trends shown
in previous years. Once again we stress that implant
survivorship aione is an incomplete measure of
outcome. Implant survivorship gives little indication of
satisfaction, relief of pain, improvement in function and
greater participation in society. Readers should also
understand that each year more data are available and
thus analysis can give a more accurate picture. Each
year's analysis thus supersedes the previous analyses
and may, in places, appear contradictory with previous
reports from a smaller dataset. Furthermore, the data
are imperfect and rely on accurate and comprehensive
reporting by surgeons. Some fields, such as body
mass index (BMI), were not initially reported but we
are encouraged that in 2012 over 60% of entries
included BMI data. We would urge surgeons to
complete all fields in the NJR forms in order to allow
meaningful analysis. This year we have analysed
survivorship for metal-on-polyethylene bearings by
head size for the first time. We have not attempted
to sub-ciassify polyethylene as what constitutes so
called third generation polyethylene is not clearly
defined. This analysis shows that there appears to be
an association between increased implant failure and
larger head sizes.
As we now have more data, we have been
able to extend brand analysis to more stem/
cup combinations. Brand analysis of stem/cup
combinations shows higher unadjusted failure rates
with uncemented stem/cup combinations than
with hybrid or all cemented combinations. The
best survivorship at nine years is achieved with allcemented components.
The in-depth analysis of hip resurfacing highlights
the high failure rate, particularly amongst women. It
also demonstrates that failure rate is related to both
gender and head size, with smaller femoral heads and
female gender independently associated with higher
rates of implant revision. In men with the largest head
sizes the failure rates are not significantly worse than
alternatives. Only 23% of men who have undergone
resurfacing in England and Wales have these larger
femoral heads.
Mortality in the first 30 or 90 days after surgery
remains very low, which is reassuring. However,
mortality at nine years after hip replacement is high in
those over the age of 75 suggesting than long-term
implant survivorship is unlikely to be important in this
age group.
We note that metal-on-metal stemmed hip
replacement and hip resurfacing have virtually ceased
with fewer than one in one thousand hip replacements
performed in 2612 belonging to each of these classes
of implant. The failure rates in these classes continue
to be markedly higher than the alternatives. Other
bearing surfaces continue to have very low failure
rates regardless of fixation, especially for ceramic-onpoiyethylene bearings.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
JEWELL 20G
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00159
In the period 2003 to 2012 589,028 knees were
replaced for the first time. The knee is made
up of three compartments; medial, lateral and
patello femoral compartments; when a 'total' knee
replacement (TKR) is implanted two out of the three
compartments are always replaced (medial and
lateral) and the pateila is resurfaced if the surgeon
considers this to be of benefit to the patient. If
a single compartment is replaced then the term
'unicompartmental' is applied to the implant (UKR).
The medial, lateral or patello Tern oral compartments
can be replaced independently,, if clinically appropriate.
There is variation in the constraint of the tibial insert
depending on whether the posterior cruciate ligament
is preserved (cruciate retaining OR) or sacrificed
(posterior-stabilised, PS) at the time of Surgery.
Additional constraint may be necessary to allow the
implant to deal with additional ligament deficiency or
bone loss, where a constrained condylar (CGK) or
hinged knee would be used, even in a primary situation.
The tibia! construct may be modular with a metallic
tibial tray and a polyethylene insert or non-modular
being constructed of polyethylene alone. In recent years
all-polyethylene tibial components have increased in
popularity so as to contain costs of the implant.
The tibial, insert may be mobile or remain, in a fixed
position on the tibial tray. This also applies to medial
and lateral unicompartmental knees. Many brands of
total knee implant exist in fixed and mobile forms with
OR or PS constraint.
The method of fixation used to secure the vast
majority of knee replacements in place is cement
(83.4% from table. 3.14), unlike hip replacements.
Tilfrhhhsijisympli!
iiliicimeitiijl^
(isiiiitleisii^^
(§f§|§l|f|§^
f§||§i§|;|||f^
fmiiiiifahlfjale^
flllllilliilll
iiiiiiiiiiiiiiiii^
jiimijlltiis^^
ffl|l;|@|ifl
fleflljllliflyiip
33A
posterior-stabilised and fixed. A number of primary
operations could not be classified according to their
bearing/constraint (approximately 2.5%).
Overview of primary knee surgery
Table 3.14 shows the proportion of all kinds of
primary knee operations performed, broken down by
fixation method and bearing type. The vast majority
of replacements were of the total knee joint with
an all cemented implant being the most common
fixation method used (83.4% of all primary knee
operations were total replacements using all cemented
components). Nearly 9% of all primary operations were
unicondylar and, of the remaining total knee replaced
joints, 6.5% were either all uncemented or a hybrid type
(made up of both cemented and uncemented parts).
Over half of all operations (54%) were total knee
replacements which were all cemented, unconstrained
andfixed,followed by 21 % which were ail cemented,
flm|}|tlli|lbill||)l3lll
Table 3.15 shows the annual change in usage of
primary knee replacement. Overall, over 80% of all
primaries utilised an all cemented fixation method
and, since 2003, the share of all implant replacements
of this type has increased by some 5%. The main
decline in type of primary surgery has been in the use
of all uncemented and hybrid total knee replacements
overtime. Each approximately has halved in terms
of proportion of implants of this type now used
compared to figures for 2003. There has also been a
steady increase in use of all cemented all polyethylene
tibial implants (2.1 % of primary surgeries in 2012
compared to less than half a percent of all primary
surgeries between 2003 and 2005).
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Table 3.14 Numbers and percentages of primary knee replacements by fixation method and bearing type.
Gomontcd and
unconstrained, fixed
317,914
54.0
unconstrained, mobile
25,931
4.4
20.9
posterior-stabilised, fixed
123,162
posterior-stabilised, mobile
8,276
1.4
constrained condylar
2.173
0.4
all polyethylene tibia
6,124
1.0
bearing typo unknown
7,359
1.3
Uncemented/hybrid and
unconstrained, fixed
18,865
3.2
unconstrained, mobile
16,502
2.8
posterior stabilised, fixed
2,479
0.4
other constraint
350
0.06
bearing typo unknown
493
0.08
2.3
fixed
13,763
mobile
46,982
6.3
bearing type unknown
729
0.1
w w w , nj rce n i r e .a rg „ uk
W
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
1-81
2 02
DEMO-00085-00161
Table 3.15 Percentage of primary knee replacements performed each year by m e t h o d of fixation and, within each
fixation group, by bearing type.
444
Comontod and
i jnconstrai nod, fixed
unconstrained,
mobile
posterior-stabilised,
fixed
posterior-stabilised,
53.3
53.0
53.0
50.7
50.5
51.4
53.1
54.5
56.6
59.8
4.0
4.2
5 2
6.3
6,3
5.6
4.6
3.9
2.8
2.3
4.9
3,5
•1.7
4.3
4.0
1.1
4.0
3.7
2.r
1.9
3.7
3.3
3.2
3.1
3.1
2. (
2.6
0,5
0.4
0,1
mobile
constrained condylar
all polyethylene tibia
bearing hypo
unknown
4.44444^^^^^^^4
Unccmontcd/hybrid and
unconstrained, fixed
ijnconstrainod, mobile
posterior stabilised,
fixed
other constraint
bearing type
unknown
0.9
0.7
0.6
0.7
0.0
0.0
0.2
0.2
0.1
0.1
0.3
0.3
0.2
0.2
0.1
0.1
1.4
6.5
2.1
6.5
2.3
6.8
2 0
6.7
6.7
6.8
0.2
0.2
0.1
0.2
0.1
0.2
2.1
0,3
0.2
0.2
0.0
0.0
0.0
0.0
0.1
0.0
0.0
0.0
2.2
2.6
6.2
2.6
5.8
2.9
6.6
0.1
0.1
0.0
tfiPli
4444444444
Unicondyiar an
fixed
mobile
bearing type
unknown
^
^w
D
wwA'.njrcentr'&,org.u!i
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
2 03
DEMO-00085-00162
2,722 consultant surgeons carried out at least one type
of primary knee arthroplasty between 2003 and 2012.
The median number of primary operations performed
by a surgeon was 107 (IQR 21 to 315) over the whole
period. lite total number of surgical units in which at
ieast one primary knee operation was carried out in the
time period was 448. The median number of operations
performed in a unit was 954 (IQR 460 to 1825).
Table 3.16 summarises the key features of the
distribution of primary operations carried out by
surgeons and units in terms of the proportions who
performed each type of procedure and the median
and IQR of the number of procedures they carried
out. Surgeons and units who performed fewer than 10
operations over the whole period were excluded (i.e.
475 surgeons and 15 units, respectively).
Surgeons performing cemented TKR carried out a
median of 137 operations of this type over the whole
period they were observed with an IQR of 47 to 316
procedures. This means that 25% of surgeons had
a caseload of fewer than 47 cemented total knee
replacements over the time and 25% of surgeons
carried out more than 316 procedures. The 10%
of surgeons with the highest caseload completed
between 517 and 2,599 all cemented primary TKRs
(not shown in tabie 3.16). The majority of surgeons
and units carried out very few, if any, uncemented and
hybrid TKRs.
Table 3.16 Distribution of consultant surgeon and unit caseload ,J for each fixation type.
Table 3.17 shows the age distribution of patients
undergoing a first replacement of their knee joint.
The median age of a person receiving a cemented
total knee replacement was 70 years (with an interquartile range of 64 to 77 years). However, for
unicompartmental primary knee surgery, patients
were typically 6 (unicondylar) and 11 years younger
(pateilo-fernoral). The 99th percentile of patient age
for all types of surgery ranged between 85 and 88
years, indicating that surgery was rarely undertaken in
a person aged 90 or older, although the maximum age
of a patient who underwent primary surgery over the
nine year period was aged 102 years.
Only surgeons or units with at least 10 primary operations recorded in the NJR are presented in the tables. The total count of surgeons who had performed
any knee operation between 2003 and 2012 is 2,722. Of these, 475 have performed fewer than 10 operations over this period. Excluding these from
reported results leaves 2,247 surgeons. The total count of units who had performed any knee operation between 2003 and 2012 is 448. Of these, 15 have
performed fewer than 10 operations over this period. Excluding these from reported results leaves 433 units.
/mji"centr8.:orgmk
183
JEWELL 2 04
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00163
Table 3.17 Age. (in years) at primary operation 1 3 for different types of knee replacement; by fixation and bearing type.
unconstrained, fixed
ro \(V\-/' r)
16
69 (62-75)
23
97
postcrior-stabiliscd, fixed
7! 164-77)
:5
102
posterior-stabilised, mobile
65 (59-73)
22
95
72 (63-79)
20
96
75 (70-79)
25
96
70 (63-77)
14
99
unconstrained, mobilc-
constrained, condylar
all polyethylene tibia
bearing type unknown
101
P^lllllllli l l l i i !
Hybrid and
bearing type unknown
69 (62-76)
69 162-76)
66 (59-74)
65 (57-73)
69 (61 -76)
fixed
63 (56-70)
mobile
64 158-711
unconstrained, fixed
unconstrained, mobile
posterior-stabilised, fixed
other bearing type
24
99
26
101
20
93
33
95
23
91
100
23
100
90
bearing type unknown
' Ages at primary operation excluding those 19 cases where age was recorded as zero years. Based on a total of 589,009 joints.
1
The interquartile range (IQR) shows the age range of the middle 50% of patients arranged in order of their age at time of primary knee operation.
1
The lowest age excluding 19 cases where age was recorded as zero years. The patella-femoral joint replacement in a one year old in the table above
certainly represents a data input error.
^ D
^w * 1
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JEWELL 2 05
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00164
33.2 Revisions after primary
knee surgery
Table 3.18 shows Kaplan-Meier estimates of the
cumulative percentage probability of first revision,
for any cause, for all cases combined and then
subdivided by knee types, Estimates are shown,
together with 95% Confidence Intervals (95% CIs),
at 30 and 90 days after the primary operation and at
each anniversary up to the 9th.
These estimates are not adjusted for other factors
such as age and gender and these will be looked
at in the future. The unicondylar and patello-femoral
replacements seem to have done particularly badly
but are generally used in younger patients. This may
be a function of milder disease in these patients, or
the desire to delay a total knee replacement for as
long as possible. Younger patients too may be more
active which puts more strain on their implants.
Figure 3.6 compares the cumulative hazard of a
first revision for the main types of primary knee
replacement surgery over time. Patello-femoral and
unicompartmental knee replacements were revised
much earlier than total knee replacements. All curves
increase in a reasonably linear fashion as time
increases, indicating that the hazard rate was, by and
large, constant over time.
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JEWELL 2 06
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00165
,A.
Ji
Table 3,18 Kaplan-Meier estimafes of the cumulative percentage probability of first revision (95%. CI) at specified times after primary knee
replacement, by fixation and bearing type.
Cemented a-id
j-kionRtiainod, fixed
.ncniiRtainrrl,
•nooile
nor-tn to -stanilisod,
tlxotl
oosteio'-stanilised,
-non He
0.02
(0.02-0.03)
0.06
(0.05-0.07;
0.33
(0.31-0.35;
0.88
(0.81-0.92:
1.33
p.29-1.33)
1.66
(1.61-1.71)
1.92
(1.86-1.99)
2.19
(2.12-2 26)
2.44
-2.36-2.53:
2.71
(2,60-2.81)
2.90
(2.77-3.04)
0.09
(0.06-0.13)
0.13
(0.09-0.18;
0.51
(0.43-Q.60)
1.22
(1.09-1.37;
184
(1.67-2.03)
2.35
(2.15-2.57)
2.65
(2.43-2 89)
2.89
(2.65-3 16)
3.14
(2.86-3.44;
3.31
(2.99-3.66)
3 78
(324-4.40;
0.04
(0.03-0.05)
0.08
(0.07-0.10)
0.43
(0.39-0.47;
1.03
(0.97-1.09)
1.53
(1.45-1.61)
189
(1.80-1.99)
2.28
(2.18-2 40)
2.52
(2 40-2.64)
2.79
(2,65-2 94)
3.06
(2,89-3.24)
3.32
(3.08-3.58)
0.07
(0.03-0.16;
0.13
(0.07-024;
0.68
:0.52-0.89;
1.56
(1.29-1.87;
2 22
(1.89-2.60;
2.73
(235-3.17;
3.08
;2.66-3.56;
3.53
(3 04-4 09;
3.84
(3.28-4.49)
3.84
(3.28-4.49)
5 01
(3.55-7.06;
0.14
0.47
1.02
1.85
2.55
3.04
3.35
3.35
3.65
4.48
4.48
(0.01-0.43;
(0.25-0.871
(0.66-1.58;
(1.30-2.61:
(1.87-3.51)
(2.24-4.IS;
(2,17-154)
(2.47-4 51)
(2.64-5.01)
(2.87-6.96;
(2.87-6.96)
0.10
(0.05-0.23!
0.39
(0.25-0.61:
0.93
(0.68-1.27;
1.48
(1.12-1.95;
1.74
(1.33-2.27;
2.29
;1.76-2.98)
2.41
(1.84-3.15;
2.64
(1.96-3.55)
2.64
(1.96-3.55)
2 64
(1.96-3.55)
0 01
10.05-0.20;
0.19
:0.11-0.32i
0.63
(0.47-0.35;
1.56
(1.29-1.89;
2.27
(1.92-2.681
2.80
(2.40-3.271
3.27
;2.31-G.0O)
3.40
(2.92-3.96)
3.80
(3.23-4.47:
3.92
(3 31-4.64)
4.36
©.34-5.60;
j-'ir.oriSt'riinecf, fixed
0.02
(0.01-0.05;
0.07
(0.04-0 13;
0.59
(0.49-0.71;
1.47
(1.30-1.66)
96
(1.75-2.13)
2 2,
(2.00-2.46)
(2.27-2.77)
.66
(2.40-2 95;
3.02
(2.71-3.36;
{2.79-3.43)
3.60
(3.04-4.27
JicnriRt "lined,
•nohiln
0.05
(0.03-0 11;
0.I0
(0.10-0 22;
0.63
(0.51-0.76;
1.38
(1.21-1.59;
2 01
4.79-2.26;
2,12
(2 17-2.71;
2.79
(2.50-3.11;
3.13
(2.80-3 49;
3.38
(3.02-3.79)
3.50
(3.10-3.94)
3 75
(3.24-4.32;
oosto-b 1 Jitaoiliscci.
0.04
(0.01-0.29;
0.08
(0.02-0 32:
0.42
(0.23-0.78;
1.80
(1.32-2.44:
2.63
3.31
4.11
4.65
5.25
6.70
6 70
2.03-3,10)
(2.61-4.19;
(3.28-5 15)
(3.72-5 80;
(1.18-6.57)
(5.15-8.70)
(5.15-8.70)
"'
0.31
(0.04-2.18;
2.23
(1.07-4.621
2.88
(1.51-5.47;
(1
3.22
190;
3.22
(1.74-5.90)
1.28
(2.42-7 53;
4.28
(2.42-7.53)
4.28
(2.42-7.53;
4.28
(2.42-7.53;
0.20
(0.03-1.43)
0.82
(0.31-2.17)
1,24
(0.56-2.74)
2.41
(1,34-4.32)
2.91
(1.70-4,97)
3.20
{1.90-5.36)
3.95
(2.41-6,45)
4,47
(2.74-7.28)
4.47
(2.74-7.28)
4.47
(2.74-7.28)
ennat -vainer! condylciall aoivoT T.lo "io tioia
nerving tyno
j-Known
I Jncomontod/hynrid a i d
fixed
oi-in e o i r l i a i i t
oearing type
unknown
0
0.20
(0.03-1.43)
n
Continued >
m
o
o
©
©
en
©
©
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Table 3.18 (continued)
:%.
oeaihg lyoe
.m-iown
0.05
(0.02-0.11;
0.10
(0.06-0.17;
0.39
(0.71-1.07;
3.01
(2.70-3.31:
4.70
(1.29-5.11)
6.22
(5.73-6.76)
7.41
l6.03-3.02j
8.37
17.71-9.07;
0.05
(0.03-0.08;
0.17
(0.13-0.22;
1.35
(1.23-1.17;
3.20
(3.01-3.10;
4.59
11.36-1.81)
5.82
15.55-6.11)
7.02
16.70~7.35.]
8.24
17.86-8.61;
9.50
;9 01-9.99;
1094
110.35-11.56;
11.86
(11.11-12.65:
U
0.11
(0.02-0.97;
0.81
10.38-1.86:
1.13
10.77-2.65;
3.17
(2.05-4.891
3.81
(2,53-5.711
1.11
;2.76-6.18!
5.11
13.61-8.09;
6.07
7.22
11,00-9.17; (4.52-11.42;
9.11
15.27-15.50;
M
m
o
o
©
©
en
©
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
9.23
9.74
( 8 5 2 - 1 0 . 1 1 ; (8.89-10.67; (-9.31-12.29;
Figure 3,6
Cumulative hazard (x100) of a first revision for different types of primary/ knee replacement at increasing years
after the primary surgery (with 95% CI).
3
4
5
6
Years since primary surgery
Numbers at risk
•——- Cemented
490,939
413,315
337,600
267,439
202,689
142,760
91,079
54,676
25,627
7,913
31,382
28,199
24,441
20,415
15,975
11,425
7,320
4,369
2,142
670
7,307
6,845
6,295
5,471
4,508
3,504
2,595
1,778
896
280
Patello-femoral
7,881
6,679
5,361
4,181
3,071
2,028
1,202
712
335
105
Unieondyiar
51,474
44,107
36,376
28,915
21,999
15,428
9,918
5,825
2,762
828
Uneemented
------- Hybrid
Figure 3.7 compares the cumulative hazard of a first
revision of a prosthesis for different bearing types of
cemented TKR. There is no marked separation of
the cumulative hazard curves for any of the types of
bearing shown and the confidence intervals for each
type overlap. This strongly suggests that the different
bearing types, by and large have similar cumulative
^ D
^w * 1
hazard of the need of revision surgery. However, the
curvature of the hazard curves of each type over time
indicates that the hazard rate changes over time with
the risk of heeding a revision of the implant in earlier
years (up to five years after surgery) being higher than
later times after surgery.
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DEMO-00085-00168
Figure 3.7
Comparison of the cumulative hazard (x100) of a knee prosthesis first revision for different bearing types at
increasing years after the primary surgery when the primary arthroplasty method of fixation was cemented
only (with 95% CI).
8
O
3
4
5
6
Years since primary surgery
7
Numbers at risk
PS mobile
- C cond
PT
UC mobile
8,276
7,257
6,147
4,958
3,854
2,812
1,782
942
352
2,173
1,661
1,294
956
730
537
335
214
106
25
6,124
4,356:
2,973
2,147
1,588
976
46:5
21 T
84
30
104
25,931
23,743
21,054
17,676
14,007
9,881
5,945
3,151
1,279
378
-------- PS fixed
123,162
104,490
85,328
67,223
50,491
35,159
22,327
13,414
6,469
1,986
UC fixed
317,914
265,085
215,218
169,856
128,326
90,705
58,653
35,853
16,905
5,226
Unknown
7,359
6,723
5,586
4,623
3,693
2,690
1,572
891
432
164
Key: DO fixed=unconstrained and fixed, UC mobiie= unconstrained and mobile, PS fixed=posterior-stabilised and fixed,
PS mobi!e=posterior-stabilised and mobile, C cond=constrained and condylar, PT=poyethylene tibia.
3.3,3 Revisions for different causes after primary knee surgery
Methodological, note
The previous section looked at revisions for any
reason. For any revision, a number of reasons may
be related to the first revision of the impiant. The
reasons are not mutually exclusive of each other.
Incidence rates for each reason have been calculated
Table 3.19 shows the revision rates for each reason
recorded on the clinical assessment forms for joint
replacement/revision surgery for all cases and then
using patient-time incidence rates; the total number
of revisions for that reason divided by the total
number of individual patient-years at risk. The figures
are given as the numbers of revisions for that reason
per 1,000 years at risk. This method is appropriate if
the hazard rate remains constant.
subdivided by fixation type and whether the primary
procedure was a TKR or an UKR, Table 3.20 shows
these first knee revision rates for each reason
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DEMO-00085-00169
by fixation/bearing type. In earlier versions of the
clinical assessment forms recording the type of joint
replacement or revision operation to be undertaken
and reasons for this, both 'stiffness' and 'arthritis'
were not originally included as options for indicating
the need for revising the implant. Therefore, for these
reasons for revision, there are fewer years at which
patients are at risk specifically for these categories.
The main reasons for revision were pain, aseptic
loosening and infection in a primary TKR. Pain and
aseptic loosening were also primary reasons given for
revision of an UKR (and amongst the highest incidence
rates for revision) alongside implant instability and failure
and dislocation. Progression of arthritis was a key reason
for revision of both unioondylar and patello-.fem.oral UKRs.
Table 3.19 Revision rates (95% CI), expressed as number of revisions per 1,000 patient-years, for each recorded
reason for first knee revision. Rates shown are for all revised cases and by fixation type.
Comcntod
1,800.0
Uncomontod
130.8
Hybrid
35.9
l Jnioondylar
191.8
Patolio-fomoral
27.6
0.78
I0.7-1-0.B2)
1.30
11.12-1.51)
0.95
(0.68-1.33)
4.16
(3.88-4.-16)
6.37
(5.50-7.38)
0.1-1
(0.12-0.16)
0.30
(0.22-0.-11)
0.20
I0.09-0.-I1)
0.93
(0.81-1.08)
1.01
(0.70-1.47)
1.16
|1.11-1.21)
0.90
(0.75-1.08)
1.23
(0.91-1.65)
0.76
(0.64-0.89)
0.36
10.19-0.67)
1.05
(1.01-1.10)
2.01
(1.78-2.27)
1.23
(0.91-1.65)
4.29
[4.01-1.59)
2.24
[1.75-2.88)
0.28
(0.21-0.26)
0.28
(0.20-0.38)
0.25
(0.13-0.-18)
0.48
(0.39-0.59)
0.07
(0.02-0.29)
0.11
(0.10-0.13)
0.15
(0.10-0.2-1)
0.08
(0.03-0.26)
0.33
(0.26-0.43)
0.25
(0.12-0.53)
0.02
(0.01-0.02)
0.07
(0.0-1-0.13)
0.06
(0.01-0.22)
0.05
(0.02-0.09)
0.11
(0.04-0.34)
Table 3.19 (continued)
Cemented
Uncomontod
Hybrid
130.8
35.9
Unicondylar
Patellofomoral
1,800.0
191.3
27.6
0.17
(0.15-0. i 9)
0.23
(0.16-0.33)
0.88
(0.19-0.59)
1.06
(0.92-1,21)
1.73
11.31-2.31)
0.67
(0.63-10.70)
0.93
(0.78- 1.11)
0.8-1
(0.58- 1.20)
1.14
(1.00- 1.30)
1.09
(0.76- 1.55)
0.37
(0.34-0.40)
0.58
(0.46-0.73)
0.39
(0.23-0.66)
0.80
(0.69-0.94)
1.85
(1.40-2.43)
0.42
(0.39-0.45)
0.50
(0.39-0.63)
0.25
(0.13-0.48)
2.37
(2.16-2.60)
4.05
(3.37-4.88)
0.39
(0.36-•0.42)
0.53
1 19.2
(0.4 1-•0.68)
0.36
30.9
(0.20-•0.64)
0.29
178.1
(0.22-•0.38)
0.66
25.9
(0.-11 -1.06)
1700.0
744.1
46.3
9.7
0.16
(0.14-0.20)
0,22
(0.12-0.40)
0
2.27
12.7
(1.96-2.63)
4.81
80.2
(3.7-1-6.18)
S
I C. •/.•)(. I-,,-!
'Intruding Hi;: on;, ;:,•
iKUV, :C. unknotvi. "The rci-soi
orrnvson surgery. Thorclor;:. Ihc.rc, ,vx: lower p-Jienl-ye-.rs:-.' rsk. " Ids reason »v;-.sn;>i ask- d in Hi;: ;,;-ry vorsi
IvIDS-.C (or jo ni" rep acei-entre-.- sion surgery and hence, for these reasons, there are fevver pat ent-years at r SK.
^ D
^w * 1
HfKTil lorn s V1DS-.-1 end
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211
DEMO-00085-00170
Table 3.20 Revision rates (95% CI), expressed as number of revisions per 1.000 patient-years, for each recorded
reason for first knee revision. Rates s h o w n are for each fixation/bearing surface sub-group.
unconstrained
fixed
unconstrained,
mobile
posteriorstabilised, fixed
posteriorstabilised, mobile
constrained,
condylar
all polyethylene
tibia
Bearing type
unknown
unconstrained,
fixed
unconstrained,
mobile
posteriorstabilised, fixed
1,100.0
110.2
448.5
32.3
15.8
30.1
83.9
67.0
11.3
0.76
(0.71-0.81)
1.09
(0.91-1.30)
0.68
(0.61-0 76)
1.30
(0.96-1.76)
0.13
(0.11-0.15)
0.24
(0.16-0.35)
0.13
(0.10-0.17)
0.28
(0.14-0.54)
1.05
(0.99-1.11)
1.23
(1.04-1.46)
1.38
(1.27-1.49)
1.14
(0.83-1.58)
0.93
(0.87-0.99)
1.35
(0.58-1.43)
1.24
(1.14-1.34)
1.18
(0.86-1.62)
0.21
(0.18-0.24)
0.35
(0.26-0.48)
0.26
(0.21-0.31)
0.31
(0.17-0.57)
[0.07-0.10)
0.15
(0.10-0.25)
0.16
(0.13-0.20)
0.28
(0.14-0.54)
0.63
(0.34-1.18)
1.30
(0.95-1.771
0.32
(0.13-0.76)
0 17
(0.07-0.40)
1.39
(0.92-2.11)
1.46
(1.09-1.97)
0.89
(0.52-1.49)
1.70
(1.29-2.23)
0.25
(0.09-0.67)
0.23
i0.11-0.49i
0.13
(0.03-0.51)
0.13
(0.05-0.35) (O.'X
0.98
(0.79-1.21)
1.37
(1.12-1.68)
1.96
11.29-2.97)
0.17
(0.10-0.40)
0.37
(0.25-0.55)
0.62
(0,30-1.30)
1.00
(0.81-1.24)
0.92
(0.72-149)
1.16
(0.67-1.99)
1.79
(1.52-2.10)
1.85
(1.55-2.21)
2.13
(1.43-3.18)
0.20
(0.13-0.33)
0.33
(0.22-0.50)
0.36
(0.13-0.95)
0.10
(0.05-0.19)
0.19
(0.11-0.33)
0.18
(0.04-0.71)
4.96
(4.35-5.64)
3,91
(3.60-4.25)
0.13
(0.06-0.29)
1.21
(1.04-1.40)
0.90
(0.67-1.22)
0.71
(0.58-0.86)
4.70
(4.11-5.36)
4.20
(3.88-4.56)
0.43
(0.28-0.67)
0.51
(0,10-0.64)
0.32
(049-0.54)
0.34
l0.26-0.46)
(0.02-0.20)
0.04
(0.01-0.08)
(5.50-7.38)
(0.70-1.50)
(0.19-0.67)
(1.75-2.88)
(0.02-0.29)
(0.12-0.53)
(0.04-0.34)
108
0.02
(0.01-0.03)
0.01
(0.00-0.06)
0.01
(0.00-0.02)
0.09
(0.03-0.29)
0.05
(0.02-0.13)
0.09
(0.04-0.20)
U
other constraint
fixed
46.4
mobile
\A9 2
Bearing type
unknown
27.6
Blue italic estimates leased on :-, sma! croup si/;: IIKSO'. iliorolcrc osi in-.:us are unrciahe. 'This re.-.sun was nol asked n IIis eariesl version ol'lhoe no:-,
assessment form MDSel (or jonl repaeomunl or revsion surgery. Therefore, I here arc lower iv.lionl-yei-.rs ;-.l rsk. 'Ths reason was nol asked n I IK: eariy vers ens
of the clinical assessmen! terms MDSvi -,nd VIDKv? lor onl roplucomonl.'mvsou surgery and lien::;:, (or ihese reasons. Ihere a.re (ewer |.uli::ni-yc.-,rs :-l rsk.
Continued >
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DEMO-00085-00171
Table 3.20 (continued)
unconstrained,
fixed
unconstrained,
mobiie
posteriorstabilised, fixed
posteriorstabilised,
mobile
constrained,
condylar
all polyethylene
tibia
bearing type
unknown
1,100 0
0.14
(0.12-0.16)
0.62
(0.58-0.67)
0.38
0 42
10.34-0.4 2) 10.38-0.4 6)
i 10.2
0.28
(0.20-0.40)
1.06
i0.89-1.27)
448.5
0.19
(0.16-0.24)
0.64
(0.57-0.72)
0.48
0.44
(0.37-0.63) (0.34-0.59)
0.34
0.35
I0.29-O.39i 10.30-0.41)
32.3
0.28
(0.14-0.54)
1.21
(0.88-1.65)
1.08
iO.78-1.51)
0.25
' " (0.09-0.67)
0.57
(0.30-1.09)
0.24
0.85
(0.67-1.07)
0.85
(0.66-1.10)
IJ
0.38
,100.0 10.35-0.4 2)
0.56
103.9 (0/13-0.72)
0.31
4 14.0 10.26-0.37)
30.9
0.97
10.68-1.391
0.14
10.12-0.19)
0.10
40.8
(0.04-0.26)
0.21
191.0
(0.15-0.29)
477.2
12.4
0.16
(0.04-0.64)
P
unconstrained,
fixed
unconstrained,
mobiie
posteriorstabilised, fixed
83.9 (0.15-0.37)
0.27
67.0 (0.17-0.43)
0.18
11.3 (0 04-0.71)
0.44
0.41
(0.32-0.61) (0.29-0.57)
0.58
0.34
(0.43-0.79) (0.23-0.521
-,r- .,
0.44
'°^
(0.31-0.62)
60.9
0.48
(0.29-0.63)
0.07
(0.02-0.27)
0.36
22.2
1.0.18-0.72)
29.6
IX)
amo-MX;
other constraint
Bearing type
unknown
fixed
mobile
46.4
0.82
(0.60-1.13)
0.93
(0.69-1.25)
0.80
1.94
10.58-1.10) (1.58-2.38)
142.2
1.14
(0.98-1.33)
1.20
(1.03-1.40)
0.82
2.53
I0.68-0.98i 12.28-2.81)
0.41
10.26-0.65)
0.25
131.3
(0.18-0.35)
43.9
2.1
"
2.84
,. ,,H „ „ „ ,
12.21-3.66,1
2.03
(1.74-2.48)
Bearing typ>
unknown
1.74
(1.31-2.31)
1.85
4.05
11.4 0-2.4 3) (3.37-4.88)
25.9
0.66
(0.4 1-1.06)
4.81
(3.74-6.18)
s
Run ill-, K: ;:sl II I-ICH h-.scd on ••. <rn yr<Mj|: ;-: ••; •ix'iOl, iluir: (on, cslin/.li'i -,r;, onrol.'-.l:!;,. 'The reason .',-/; nol asked n Hi;: ;,.-,r ;.sl '.arson "I irit: allien
assessment ton - VIDSy1 for ,o nt replaceireiit or rs.• s on surpsry. Thereto e. there are fev,-sr patent-years at risk. 'This reason •/.•as not asked n the ear y versons
otthec noa assessment ronrs "<1DSv1 and vIDSvx for oint rep aeenent-' evison surgery and hence, tor these reasons, there are fewer pat ent-ysers at risk.
^ D
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DEMO-00085-00172
33.4 Revisions after primary knee
surgery by main brands for TKR
and UKR
where fewer than 100 primary knee joint replacements
remain at risk. No attempt has been made to adjust
for other factors that may influence the chance of
revision so the figures are unadjusted probabilities.
Tables 3.21 and 3.22 show the Kaplan-Meier
estimates of the cumulative percentage probability of
first revision (for any reason) of a primary TKR (table
3.21) and primary UKR (table 3.22) by implant brand.
We have only included those brands that have been
used in a primary knee procedure in 1,000 or more
operations. Figures in blue indicate those time points
Table 3.23 shows Kaplan-Meier estimates of the
cumulative percentage probability of first revision of
a primary TKR or primary UKR by implant brand and
bearing type for those brands/bearing types which
were implanted on at least 1,000 occasions.
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DEMO-00085-00173
MP
AGC
5,258
0.29
(0.17-0.49)
1,20
(0.91-1.58)
1.62
(1.27-2.06)
1.98
(1.58-2.48)
2.22
2.94
(1.78-2 77) (2.33-3.71)
3.17
(2.50-4.01)
3.42
(2.63-4.45)
53,440
0.28
(0.24-0.33)
0,92
(0.83-1.01)
1.38
(1.28-1.50)
1.74
(1.62-1.88)
1.97
(1.83-2,11)
2 30
(2.14-2.47)
2.54
(2.35-2,74)
2.85
(2.62-3.11)
Columbus
4,319
0.45
1.54
(0.28-0 72) (1.16-2.04)
2.07
(1.60-2.66)
2.52
(1.97-3.23)
2.88
3,29
(2.23-3.73) (2.48-4.37)
-i 3?
(2 58-7.151
4.3/
<2.33/.35;
E-Motion
Bicondyiar
Knee
2,001
0.69
(0.40-119)
1.55
(1.05-2.27)
2.54
2.64
(1.84-3.50) (1.92-3.62)
2.79
3 55
(2.03-3 83) (2.41-5.22)
8.56
(2 31-522}
3.53
<2x? 7-5.22;
Endopius
Bicondyiar
Knee
13,833
0.70
(0.57-0.86)
1.34
(1.16-155)
1.81
(1.59-2.05)
2. IS
(1.94-2.45)
2.44
(2.17-2.74)
2.85
3.00
(2.53-3.23)
(2.58-3.48)
Genesis 2
30,010
0,42
(0.35-0.5I)
0.96
(0.84-1.10)
1.39
(1.23-1.56)
1.84
2.07
(1.64-2 06) (1.85-2.32)
2.27
2,34
(2.01-2.56) (2.07-2.66)
2.43
(2.11-2 79)
Genesis 2
Oxmium
4,832
0.55
(0.37-082)
1.35
(103-1.77)
2.25
2.69
(1.80-2,82) (2.17-3.34)
InsallBurstem 2
2,058
0.30
(0.13-0,66)
0.90
1.58
(0.57-1.43) (1.11-2,24)
10,862
0.24
(0.16-0,35)
1.03
(0.86-1.25)
2,038
0.64
(0.37-1.10)
18,235
Maxim
MRK
Kinemax
LCS
LCS
Compieie
3.37
(2.71-4.19)
2.68
(2.38-3.02)
3.75
(2.99-4.71)
3.12
(2.83-3.45)
3.55
(2 J>5.22>
4.50
(3.51-5.77)
i3.50-S.28,
2.17
(1.61-2.93)
2.69
3.08
3.45
(2.04-3,53) (2.36-4.00) (2.67-4.46)
3.79
(2.91-4,93)
3.79
(2.91-4.93)
1.76
(1.52-2.03)
2.21
(1.95-2.51)
2.67
(2.37-3.00)
3.49
(3.13-3.89)
3.91
(3.50-4.37)
4.30
(3.81-4.86)
1.09
(0.72-1.65)
175
(1,26-2.43)
2.06
2.33
2.39
2.61
(1.52-2,79) (1.75-3.10) (1.80-3.16) (1,99-3.43)
2.74
(2.10-3,58)
2.94
(2.25-3.83)
0.47
(0.38-0.56)
1.13
(0.98-1.31)
1.70
(1.50-1.93)
2.25
2.64
(2.01-2.53) (2.35-2.96)
2,124
0,30
(0.13-0.66)
0.93
1.63
(0.59-147) (t.14-2.32)
2.02
(1.46-2.80)
2.33
2.33
(1.71-3.18) (1.71-3.18)
3.02
(2.18-4.19)
3.33
54m
(2.35-4 72) (3.CXJ-S.3S)
5,534
0,27
(0.16-0.45)
0.76
132
(0.55-1.06) (1.01-1.71)
1.63
(1.28-2,08)
1.73
(1.36-2.21)
1.83
(I.42-2.36)
3.33
(1.74-6 31)
3.00
(2.68-3.36)
2.88
3.12
(2.56-3.24) (2.73-3.56)
1.83
(1.42-2.36)
4.BP
3 I?
(2.73-3.55
3.33
(!.54-63;}
2,66
2.80
2,80
2-30
(1.98-3.61) (2.06-3.79) (2.06-3,79) (2.05-3-29;
0.37
0.88
1.38
1.74
2.16
2.47
2.75
3.06
3.26
73.966
(0.33-0.42) (0.81-0.96) (128-1.48) (1.63-1.87) (2.03-2.31) (2.31-2.64) (2.56-2.95) (2.82-3.32) (2.96-3.60)
0.73
2,14
2.56
3.26
3.74
4.09
4.62
5.45
5 53
2,232
(0.44-1.20) (1.57-2.91) (1.92-3.41) (2.49-4.27) (2.87-4.87) (3.12-5.35) (3.33-6.39) i3.53PJ.Wj (3 63-3.10:
Natural
Knee II
2,538
0.33
(0,17-0.67)
0.88
1.32
(0.57-1.37) (091-1.91)
1.76
(1.26-2.45)
2.21
(1.62-3.01)
187,728
0.36
(0.34-0.39)
0.87
(0.82-0.91)
1.55
(1.48-1.62)
1.81
(1.73-1.89)
(1.
1.96
-2.05)
2.14
(2.04-2.24)
2.30
(2.19-2,42)
2.45
(2.30-2.61)
Prefix
3,941
0,36
(0.22-0.61)
0.98
1.22
1.52
(0.71-1.36) (0.91-1.63) (1.17-1.98)
1.81
(1.41-2.33)
2.28
(1.78-2.91)
(1.84-3.01)
2.36
(1.84-3,01)
2.94
(1.90-4.53)
Rotaglide
1,067
0,21
(0.05-0.84)
0.58
(0.24-1.40)
1.62
(0.92-2.85)
2.59
3.08
; 50
(1.55-4.30) (1.81-5.21) ,2.'5-6.66!
3.80
(2 15-5.03,
ISO
(2.15-666!
Rotaglide +
2,108
0.57
(0,33-1.01)
1.85
(1.35-2.53)
2.79
3,40
(2,15-3.61) (2.69-4.31)
3.66
(2.91-4.60)
4,12
(3.30-5.14)
4.62
4,74
(3,71-5.74) (3.81-5,90)
5.45
(4.19-7.07)
Nexgen
Opetrak
PFC Sigma
Bicondyiar
Knee
1.28
(1.22-1.34)
2.01
(1.18-3,41)
Scorpio
34,185
0.40
1.17
(0.34-0 47) (1.06-1.30)
1.71
(157-1.86)
2.08
(1.92-2.26)
2.43
(2.25-2.63)
2.70
3.13
(2.49-2.92) (2.87-3.40)
3.26
(2.98-3.56)
Triathlon
29,766
0.44
1.07
1.54
(0.36-0 53) (0.94-1.22) (1.36-1.74)
1.84
(1.62-2.10)
1.93
(1.69-2.21)
2.11
2,98
(1.78-2.50) (? Q9-4.€0>
2.58
0.8S-3.8Q:
Vanguaro
1 7,098
0.35
(0.26-0.46)
2.04
(1.68-2.48)
2.36
2,56
3 51
(1.92-2,91) (2.00-3.26) (2 02-3./0!
3.41
(2.02-540!
0.95
(0.77-1.16)
1.57
(1.30-1.89)
3.53
(3.13-3.97)
Estimates in blue indicate that fewer than 100 eases remain at risk at the time shown.
Brands shown have been used in at least 1,000 primary total knee replacement operations.
^
D wwwjijrcentre.orcj.ul'
^w * 1
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215
DEMO-00085-00174
Table 3,22 Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CD of a primary
unicompartmental knee replacement by main type of implant brand at the indicated number of years after
orimarv operation. h
0. /ft
{0.52-1.1 ll
{1.39-2.03i
.0i
{3.3/-/.,ft:
b.nH
{/ ,'9-6.r;G;
/.6fi
{6.69-8.112)
1,22/
O.GG
{0.43-1 65j
436
{3.06-5.6/1
6.36
•/.88-0.23)
3.7/
{6.30-11.21;
9 .'ft
{7/0-ft./;/
Journey PFJ
Ox •" i,m
1
1.98
{1.26-3 Oil!
•' 60
8.20
969
13.89
•3.39-6 23: {6/3-10/3; -7.68-12.19; il 1.08-1/34)
AMO/Uc g ice
2,279
Aver
379.-
j-,'7/
MO U noouOy R'
Oxlcrc P a / a
K-cc
2,361
{O.o8-l.3/i
1.10
K KJ jl
' - ~ ' {1.07-1 30!
1,509
2.26
{1.62-3
62-3 15:
15)
Sigma I IP
3,1/2
1.0/
{0./2-1.501
Zcnnior
U'4cc-Tioa-.Ticn.
.-, •.-.,
•.;., •..'
0.52
{0 32-0.35!
19
12.53
I!0./2-14.61I
2.5fi
•{ 1.99-3 3.'.!
Picscrvato--
,s
10 9 /
12.60)
2.53
.9/-3.261
2.91
73-3.10:
4.86
{3.89-6.08;
3. i/
2.11
4.19) ..-•.-;.3.83
472
571
6.6/
/.03
{3. 12-/ /0: {3 92-0.69) {/.80-679: {6.62-/8/; {o 93-8.32; {6.08-8.n9;
1149
4.25
5/3
6.61
7.32
9.10
10.52
{/.03-/.5C: {5 16-0.71: {6.30-6.95; 7 / / - G . 2 1 ; •0.63-9.50; {9.92-11.151 {10.72-12.31:
r.rfl
9.5/
11.13
12.;,o
l3.8o
I0.O8
.;0.29-8.99l {8.1/-H.20} {9.60-12.89) 110.81-14 -'6; 112.00-b.9/) (13.00-1//6l ft
4.96
:-•: •
ft/;
3.36
4 69
5.27
ft
3/
ft.//
ft
2,
Estimates in blue indicate that fewer than 100 cases remain at risk at the time shown.
Brands shown have been used in at least 1,000 primary unicompartmental knee replacement operations
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216
DEMO-00085-00175
Tabie 3.23 Kaplan-Meier estimates 01 the cumulative percentage probaonty of first revision (95?o CI) of a total knee
replacement at the i, idioated number of years after primary operation, by main implant brands and type or fixation
and constraint'
c m c r cc
J X C X . ai-PCixT
181
n
cr-nv.-r.00
J'XOIS,.ai x c .
ixec
0 30
I 22
0.2I-0.30: (O./fi-O.O-ij
Urccm c-r.cx /
•VOX
.rxone -a ix x
i'xoc
IH
2 22
2 <T-
•C iC 0 50: 'C 93-1 CC. 127-2 00 i1 08-2 9, '138 2 70: 23 3 73' .2 In- Cm '2 i
(I 21-1.43)
: i mo-1.82! i 1.76-2.On: (2.07-2.4 I) i2.26-2.66l (2.53-3 01)
\.U
2 51
2.91
8.42
3,n.'
3 99
4
(0.76-i 72) (1.90-3.31) (2.25-3.77) (2.66-i.39i (2.76-1 Mi (3.09-5. K) (3.25-n
P H W §1
corner..cc
.noons•carx o .
ixoo
Uxomo'ioci/
.jixorsrirxec.
•merle
'
3,2r9
CC ' i C ' X
COS e 10'
)|x\d, [.X(X
Cemented
unccostrained, fixed
Uncemented/
hybrid unconstrained, mobile
,K9
0.89
1.50
2.08
2.20
2.37
3.26
(0.31-1 36: (0.35-2.3'! 11/1-3.06! (1.30-3 23: (1.61-3.47: (2.01-O.20)
,, ,.0 , _, '
H
J
0 66
IO 13-0 721 (C3C-1 1C-
_/'
0 91-2 01
1 7C 2 97:
2 3 1 3 99
2 01
2-'8
: 1 " i - 2 75l (179-3 20:
2 58 4 *2" <2 80 -' CCl
i Hi
3 '18
2 00-3 GO '2 3 3 - 1 3 1 (2 5C-' 07:
2 53 1 6 7
10,656
0.25
1.05
1.78
2.22
2.69
3.03
3.51
3.94
4.28
(0.17-0,36) (0:88-1 .-27) (1,54-2.05) (1.95-2.53) (2.39-3,03) (2.71-3.40) (3.14-3.92) (3.52-4,40) (3.79-4.83)
1,356
0.74
1.12
1.80
2.11
2.35
2.35
2.43
2.43
2.43
:(0.40-1.38) (0.67-1.85) (1.21-2,67) (1.46-3.04) (1.66-3.32) (1.66-3.32) (1.72-3.42) (1.72-3.42) {1.72-3.42)
^ f§ wwwjijrcentre.org.ul'
^W ^
Continued >
JEWELL
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
217
DEMO-00085-00176
Table 3.23 (continued)
a-"00. xoo
ooslc-' Of
Staoi aec/ixad
U-'co-rK-'i.ma.-
20-0.32; (0.57-0.78; (0.96-1.25; -1.2/-1.59i d .16-1.87; d.75-2.28) -1.88-2.52.! (2 03-2.93; i2.03-2.93i ™
,,p £;i . 1
"OA"
0/3
0.9/
1.11
1.0/
2.37
2.65
2.99
3.38
3.62 -g.
{031-0.51; (0.81-1.Ou; 11.30-1..58) ii.68-2.02) {2 11-2.58; (2/3-2.89; I2.13-3.28i (3.0/-3.16) 13,20-'.Ill 9
: TI reo. ixeo
oosLC'C-r
staoi aeo.ixacl
^)P¥sp
Continued >
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177
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218
DEMO-00085-00177
Table 3.23-(continued)
arrx
.C23
_
i 04-0 .
5
CoC
23
r ,--'
0P"-l
2C
08I-I80:
1 or
- ,;
1 20
<"-i-lM|
1 20
i0cx-|Cl!
1 2f
0-6-I9I.
1 20
<-,-,,•
XT
cClCl' Z
"•(---<;Ic'ID I
' I I
C010J3
iO10 1 02
I ( Id
| <T
'0 67 2 C3l
110 3
p i,-
5i
I 33 ' 30
i1 00 0 37
ll>Tj
0.20-0.8c-: i1 13-2.301 ;l.9n-3.6/) (2/3-/ 10) {2.66-4.38: i.2.88-P8ci) (8.09-6.18) •3 21-6.30; i3/0-6.0i|
.ranee. Tioo
'TiCO C
onste'O'
~':
s.noi soo.
TiOOi o
(0.08-0.80)
11.00-2.51l
(1 6 5 - 3 / G i
(2.2/-4.36)
{260-/.07;
(2.81-5.59
0.20
4720-0.42;
1.07
40.8.-1.30:
1.62
(1.37-1.91:
1.0/
(1.66-2.27)
2.36
'2 03-2. /3)
2.63
2.85
(2.2 7-3.061 (2/3-3.33':
(
(
0 37
1,872
4
lhco-no-.od.
•"voio
^ TG"~1S:raneo. ~"xeo
, .,„
• ,;' I 2
COTiTlT
Ta-j'Xnai'cd.
TXT
22,353
poslcc
s'.aoi sec
"""
Xfif.
1
1
6
-
0
.
8
9
)
1.48
0
.
6
7
-
I
.
/
0
;
0
.
9
D
-
2
.
3
1
)
1
.
2
8
-
2
.
/
'
i
(
1
.
4
4
-
3
.
1
0
)
{
1
x
4
-
3
.
2
8
1
{0.40-0.36;
(1.01-1.73i
1.64
d.30-2.071
l./f
:1/2-2.23'i
13
{1 71-2.66)
2.26
f1.81-2.83i
0.38
4130-0.48)
0.9c
1.0.79-1.11;
i..-|ft
(1.2/-1.72)
|./6
(1.80-2.0c)
|,B3
{1.66-2/6:
2.0
11.67-2/.
:I
{086-0.78;
t .24
(0.06-1.60) ;l . ] n - l . 0 0 i
(1.46-2.61)
2.10
(167-2.87;
///-/('i/
0.33
(0-.24-0.46)
0,91
(0.72-1.14)
2.04
(1.63-2.55)
2.48
{1.94-3.18)
2.81
'(2.05-3.84)
0
x
0
2.05
12x0-3/8!
2.12
1.01
(
2.05
(2.60-3.48;
•
1
.
6
7
-
3
.
8
6
'
:
8.20
(2.52-/.20)
-
1
0
7
-
3
x
6
)
3/6
(2.6/-
^XN^>CCr>DcW^gg
cemented
unconstrained,
fixed
IMimm&m
(staiBiiiSSdl;
(fiiXBEf>;(((//:
20
21
14,185
1.52
(1.23-1.88)
8.62
12.17-8.69;
3.82
wmi
wWi
m.
wmmmmmmm
mom 3®mmmU
WMM&M M^WmWt WmmmWt /{ii:52i4:;i7)(;
Estimates in blue indicate that fewer than 1 GO cases remain at risk at the time shown.
Brands shown have been used in at least 1,000 primary knee replacement operations for that type of fixation and bearing type.
^ D
^/ v S - * '
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219
DEMO-00085-00178
3 3 3 Mortality after primary
knee surgery
This section gives the cumulative likelihood of a
patient dying at different lengths of time after their
primary operation date by age and gender. Cumulative
probabilities of a knee replacement patient dying in the
short term (by 30 days or 90 days after the primary
operation) and in the longer term, up to nine years
after their primary operation, are shown. For simplicity
here, we do not take into account whether the patient
had further operations (i.e. revision of any primary
joint) after the primary operation in calculating the
cumulative probability of death.
Of the 589,028 records of a primary operation to
replace a knee joint over the period 1 April 2003 to 31
December 2012, 181 not did have an NHS number
therefore the death details could not be traced. A
further 22 had missing age (19) or gender (3). Amongst
the remainder, 7,572 were bilateral operations, having
both knees replaced on the same day. Patients
identified as having a bilateral operation have had the
second recorded joint excluded from the sample used
for mortality analysis.
This identified a sample of 581,253 distinct patients
who had had a primary operation to replace one or
both knees within the NJR data collection and follow
up period. Analysis of the cumulative likelihood of a
patient dying in the short or medium term after the
primary knee surgery are based on this sample of
patients. In total, 43,155 deaths were linked to this set
of patients over the time period.
Table 3.24 shows, by gender, the age distribution of
patients who underwent primary TKR or UKR surgery
over the data collection period. Fewer men than
women, overall, have had a primary knee replacement
and, proportionally, more women than men undergo
surgery above the age of 75.
Table 3.24 Age and gender distribution of patients undergoing all types of primary knee replacement operations
for the period 2003 to 2012.
4.1
:
23,576
29:,9o:1
iiill:
47,426
47,426
Under 55
*SSs5§:
§isii!ii
60-64
liB^aTdgggg
iliiiii
70-74
70-74
;:;:;«^^
lllllllll
wmm
80 and above
Table 3.25 shows the Kaplan-Meier estimated
cumulative percentage probability of a patient dying at
the indicated number of years after surgery stratified
by age group and gender. Males, particularly in the
11111;:
sm
8.2
i<<<<<<<<<<<<<<<<<<<<<<<<<<yyWSk
63,898
11.0
59,293:
lliii
mm
50,660
older age groups, had a higher cumulative percentage
probability of dying in the short or longer term after
their primary knee replacement operation.
/mjrcentre'.:G'rrj,u.k
179
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22 0
DEMO-00085-00179
133
©
Table 3.25 Kaplan-Meier estimated cumulative percentage probability (95% CI) of a patient dying at the indicated number
of years after a primary knee joint replacement operation (i) by age group and gender and (ii) for all patients.
m
o
o
©
en
©
CO
©
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
33,6 Conclusions
The data shows some strong trends that merit further
discussion. We hope that this will provoke debate and
encourage surgeons and manufacturers to re-evaluate
their practice in light of the evidence provided. We
accept that the data are open to other interpretations
and we welcome this. Once again, we must stress
very strongly that the NJR provides only part of the
picture, that of survivorship, and only survivorship of
a short- to medium-term duration; and now for the
first time some Patient Related Outcome Measures
(PROMs). We do not know whether these trends will
continue in the longer term. Indeed, one of the lessons
that we have learnt is that survivorship is not linear.
Moreover, the data are imperfect and we are reliant
on surgeons completing the data accurately and
recording every procedure without exception. Some
data fields continue to be poorly completed making
meaningful analysis difficult.
Unlike hip arthroplasty, the practice of knee
arthroplasty has not changed significantly over
the past eight years. This year's analysis shows a
continuation of the trends shown previously with total
knee replacements surviving markedly better than
partial knee replacements.
Overall, the data show that short to medium-term
survivorship is excellent after almost all common
types of total knee replacement regardless of fixation,
constraint and bearing type. For the first time we
report on PROMs data. This shows that all types of
total knee replacement give significant improvement in
the majority of patients (see section 3.5).
For bicondyiar knee replacements, unconstrained
implants tended to have slightly lower revision rates
than posterior cruciate-stabilised implants while mobile
bearing prostheses tended to have a slightly higher
failure rate than fixed bearing prostheses. Thus, the
lowest revision rates were associated with a cemented,
unconstrained, fixed bearing prosthesis. However,
these differences are small and the results in ail these
groups are acceptable. This also holds true for analysis
within brands. This year the brand analysis has been
extended to more brands as more have reached the
threshold number of cases needed to do this.
Patello-femoral joint replacements have a very
high failure rate and were typically revised for pain.
However, it should be remembered that patellofemoral joint replacements are undertaken for different
reasons than total knee replacements and so a direct
comparison of revision rates would be erroneous.
Patello-femoral joint replacements may be revised to
a total knee replacement because of problems with
a different part of the knee and so the reason for
revision may be unrelated to the original procedure.
In addition, there may be reasons related to the
aetiology of patello-femoral arthritis that could explain
why replacing the joint, without significantly correcting
the underlying biomechanical cause, may not always
be a successful strategy. Patello-femoral joints lead
to a significant improvement in PROMs, but the
improvement is not as marked as with unicondylar and
total knee replacements.
Unicondylar knee replacements also have a higher
failure rate than total knee replacements. They were
commonly revised for pain and loosening. Again,
unicondylar knee replacements may be undertaken
for different reasons than total knee replacements
and they may be revised to a total knee replacement
because of disease progression in a non-operated
compartment which is unrelated to the original
procedure. Therefore, comparing revision rates
with total knee replacements is not straightforward.
The improvement in PROMs after unicondylar knee
replacement is very similar to that achieved by total
knee replacement.
We report mortality after knee replacement using
slightly different methodology to last year. Once
again we show that knee replacement is associated
with a slightly lower risk of death compared to hip
replacement. We are currently conducting an in-depth
study of post-operative mortality.
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JEWELL 2 2 3
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DEMO-00085-00182
3,4,1 Overview of primary
ankle surgery
There were 1,417 primary operations (see Tables 3.1
and 3,2), including two bilateral operations performed
at the same time.
This section looks at revision and mortality for
all primary ankle operations performed up to 31
December 2012.
Table 3.26 summarizes the procedures by year of
primary operation;
Table 3.26 Number of primary ankle operations by year.
2009
2010
2011
2012
o
138 -g
505
o
—>
"5j
-'16 o
The median age at primary surgery was 67 years (IQR
61 to 74 years) and, overall, the ages of those having
a first replacement of an ankle joint ranged between
24 and 91 years. Men made up 57.2% of all who
underwent primary ankle replacement surgery.
All procedures were uncemented apart from two in
which both cemented talar and tibial components
were recorded and a further four for which there
was either no component data, or the data were
inconsistent.
The maximum number of procedures carried out by
any consultant was 102.
Similarly the total number of units involved was 175;
37 (21 %) of them carried out 10 or more procedures.
The maximum number of procedures carried out by
any unit was 94.
Table 3.27 below shows the distribution of ankle
brands. Mobility was the main brand used (56.5% of
procedures) followed by Zenith (19.6%).
The procedures were carried out by 165 Consultants;
44 (27%) of them performed 10 or more procedures.
Table 3.27 Number of primary ankles by ankle brand.
Mobility
Zenith
Box
Salto
Star
Hintogra
Rebalance
In bono
Taric
Not known
a s
800 (56.5)
280(19.8) „
91 (6N) o
86(6.1) j
69 (4.9) |
rr
56(4.0)
17 (1.2)
2(0.1)
i (0.1)
©
15(1.1)
SIMliiwI
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DEMO-00085-00183
3.4.2 Revisions after primary
ankle surgery
The maximum follow up time available was 4.63
years and, up to the end of December 2012, only
nine revisions of the primary ankle implant had been
recorded in the NJR. Estimated Cumulative percentage
probabilities of revision (based on Kaplan-Meier
estimates) at 30 days, 90 days, 1 year and 2 years,
respectively, were: 0.07% (95% CI: 0.01%-0.50%),
0.14% (95% CI: 0.04%-0.58%), 0.24% (95% Cl:
0.08%-0.74%) and 1.40% (95% CI: 0.69%-2.83%)
Table 3.28 below lists the stated reasons for the
nine revisions.
Table 3.28 Reasons for ankle revision (not mutually exclusive).
Mig§(^^
Low suspicion (awaiting micro/histology)
tM&^tMM^^ML
Tibia! component
Lysis.
Talus
Plilllhiiehlill
Implant fracture
W&ialpoW^
Tatar component
Wear of polyethylene component
tlVppisbal
Component migration/Dissociation
Stiffness
xSpfThtssplm^
Other indication for revision
"Same patient had both of these reasons.
3 A 3 Mortality after primary
ankle surgery
There were 17 deaths in total. The estimated
cumulative percentage probability of death (using
^ D
^w * 1
Kaplan-Meier) at 30 days, 90 days, 1 year and 2 years
were, respectively: 0.0%, 0.15% (95% CI: 0.04%0.59%), 1.05% (95% CI: 0.59%-1.85%) and 1.49%
(95% CI: Q.88%-2.51 %) There were too few deaths for
further breakdown by age and gender.
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DEMO-00085-00184
Annexe to survival analysis
In a departure from our previous reports, in the tables
above, we have used Kaplan-Meier estimates for
the cumulative probability of failure (i.e. where failure
is either a revision or death) at given times t, F(t).
Previously we had reported Nelson-Aalen estimates of
the 'cumulative hazard' (also called 'integrated hazard').
This change in reported values brings us more in
line with the form of reporting undertaken by other
National Registries and, therefore, makes for easier
comparison with published work from these and other
research bodies.
The cumulative hazard at time t after primary
operation, say H(t), is not the same as the cumulative
probability of failure, F(t). To understand H(t), first start
with the concept of the 'hazard rate' (analogous to
the 'force of mortality' used in actuarial science). In
the case of revision, the hazard rate at time t is the
(instantaneous) rate at which revisions are performed
amongst those cases that have not been revised
previously. For discrete observations over time, the
cumulative hazard at time t is the cumulative sum
of the hazard rates; in continuous time it is the area
under (i.e. the integral of) the hazard rate curve. The
cumulative hazard here is estimated from the data
using Nelson-Aalen estimates to account for the
discrete time nature of observations.
Although the 'cumulative hazard' (H(t)) and 'cumulative
probability of failure' (F(t)) are estimated using different
approaches, they are mathematically related through
the expression F(t)=(1 - e (-H(t))) and so it is possible
to estimate one using an estimate of the other. Where
failure rates are less than 10%, the numerical value of
e (-H(t)) is numerically close to the value of 1 -H(t) and
therefore F(t) is close to H(t). The values of F(t) and H(t)
do not remain numerically similar once failure rates
exceed 10% and then, in general, H(t) will be greater
than F(t). This has become particularly noticeable in
the NJR data set for mortality where, after nine years,
the estimate of H(t) for 80+ year old men now has
exceeded 100 (expressed as number of deaths per
100), whereas, because F(t) is a probability, its vaiue
cannot exceed 100%.
It is useful to use cumulative hazards for plotting, e.g.
to compare revision rates for various sub-groups.
As with the cumulative probability of failure, groups
with greater cumulative hazards will have the highest
revision rates. The shape of each cumulative hazard
curve, however, carries useful information about how
the revisions occur because the gradient of the curve
at any time t estimates the hazard rate. If the plot of
the cumulative hazard against time is a straight line,
then revisions will have occurred at a constant rate
throughout, i.e. the revision rate is independent from
time of operation. If the graph increases exhibiting a
concave shape, then the risk of revision will be lower
initially, increasing with time after operation. The
converse is true; if the shape is convex, revision rate
would be higher initially.
For the above reasons we give Kaplan-Meier
estimates in the tables but have retained estimates of
'cumulative hazards' for plotting.
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3.5.1 Background to Patient Reported
Outcome Measures (PROMs)
PROMs assess the patient's experience and
perspective of the quality of care and treatment they
receive when they undergo a NHS-funded hip and/or
knee replacement. PROMs are collected via pre- and
post-operative questionnaires; the items allow the
patient to self report on their state of health and general
lifestyle before and after their joint replacement surgery.
These outcomes provide a means of determining the
impact the procedure has subsequently had on their
quality of life. PROMs have been routinely collected
by all providers of NHS-funded care in England
since April 2009. The initial questionnaire, Q1, is
normally administered just prior to the operation and
questionnaire Q2 approximately six months following
the operation. Additional information is available from:
http://www.hscic.gov.uk/PROMs
In this section we have concentrated on the variables
that described health benefits following primary hip or
knee replacement.
3.5.2 Data linkage from PROMs to
neb t u nJK
Our base PROMs data file had 445,134 entries
(207,436 hips and 230,429 knees).
complete but it was not possible to choose the 'higher
quality' record from the remaining 90 multiple entries
and so these were omitted. This left 324,101 PROMs
entries, some of which related to primary and some to
revision procedures.
HES to NJR matching:
Within the HES data set, seven rankings were available
resulting from linkage methods designed to determine
the most likely NJR operation identifier for a given
patient/episode in HES. The linkage method utilises
and ranks the availability of various combinations of
patient information associated with a particular HES
episode. Relevant patient related information included
patient NHS number, date of episode/entry, provider
code, local patient ID, date or year of birth and patient
gender. In addition, an episode in HES must have
an 'orthopaedically relevant' ORGS procedure code
associated with the particular episode i.e. OPCS
codes must identify an orthopaedic type of event.
The linkage rankings were used to assign the most
probable NJR operation number to the HES person ID
(HESID) and episode (EPIKEY).
Not all of such 'orthopaedically relevant' HES episodes
had entries in the NJR. However, of the 517, 220
HES entries between 2003 and 2012 we were able to
assign 391,240 (75.6%) to an NJR procedure.
PROMs/HES to NJR/HE5 matching:
Q1 and Q2 had already been linked together when
received by the NJR.
Linkage between PROMs and the NJR data set could
only be made via Hospital Episode Statistics (HES) data
spanning the same time period as the PROMs data set.
PROMs to HES matching:
A total of 3% of the PROMs entries had no HES patient
identifier (HESID) and a further 24% of the remainder
could not be matched to a particular episode in HES
(via EPIKEY). Of the remaining 326,876 PROMs entries,
there were 2,653 duplicate matches and 16 triplicate
matches to HES, meaning that multiple PROMs entries
existed for the same HES patient episode. For these
multiple matches, we chose the 'best match', i.e. the
PROMs entry that had the best episode matched rank.
In 234 cases there were two equal best matches; we
gave priority then to the 144 PROMs entries that were
Finally, we were able to link 274,729 of the above
324,101 PROMs entries to HES patient episodes
with an assigned NJR operation identifier. There were
some duplications i.e. instances where more than one
PROMs entry could be ascribed to the same NJR
operation. At this juncture we linked the PROMs data
separately to our linked data files for primary hips and
knees, after first removing bilateral operations from
the latter. Any remaining duplications were removed
pragmatically, by checking gender match, NJR patient
identifiers and finally by choosing the PROMs entry
where the date of completion of Q1 was closest to the
date of the operation.
The remainder of this section provides some simple
summary statistics for the PROMs entries that could
be matched to our unilateral linked primacy hip and
knee files.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Methodological note
The three health measures in PROMs are the EQ-5D
Index, the EQ-5D Health Scale and the Oxford Hip/
Knee Scores.
22
The EQ-5D Index is derived from a profile of
responses to five questions about health 'today',
covering activity, anxiety/depression, discomfort,
mobility and self care. Weights had been applied to
the responses to these questions to calculate the
'index'. All five questions had to be answered in
order to do this. The higher the index the better the
patient, with one being the best possible score. The
distribution of the EQ-5D Index is such that parametric
statistical methods are not suitable for statistical
comparison. Non-parametric unpaired and paired
comparisons (two-tailed Mann-Whitney and Wilcoxon
matched-pairs signed-ranks) have been used here
but, because of the 'ceiling effect' (scores cannot
improve beyond 1), paired comparisons were doublechecked with simple sign tests.
Tine EQ-5D Health Scale is a visual analogue scale
(VAS}, asking about how the patients rate themselves
'on the day' (0=worst, 100=best).
The Oxford Hip/Knee Scores are based on
responses to 12 hip or knee specific questions
about health 'in the last four weeks'. Each question
is scored from 0 to 4 and the scores are summed to
give a score from 0 (worst) to 48 (best). If fewer than
three responses to individual questions are missing,
they can be replaced by the mean of the remaining
questions.
The VAS was not normally distributed, neither
were the Oxford Hip and Knee scores at Q2; nonparametric methods of comparison, therefore, were
used for both these variables.
Summary statistics used throughout this section are
the median and Inter-Quartile Ranges (IQRs). The latter
is less sensitive to outliers than a simple range. (Note
however that, for paired data, the median difference
may not be equal to the difference in medians.)
3.5.3 PROMs outcomes tor primary
hip replacements
A total Of 124,136 of the linked primary hip operations
in NJR had an associated PROMs entry; 01 was
complete in 99.7% of these and both Q1 and Q2
were complete in 75.6%. The median (IQR) interval of
time from completion of 01 to the primary operation
was 0.59 months (IQRO.23-1.22; n=84,078) and
from primary operation to completion of Q2 was 6.47
months (IQR 6.31 to 6.87; n=83,808).
Table 3,29 opposite shows the overall outcomes after
primary hip surgery.
22
As the index is bounded between' 0 and 1, we present results in this section with respect to the EQ-5D Index to three decimal places for greater precision.
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DEMO-G0085-0G188
1,924 (2.
89,998 (97:
2Nc
Bias in completion of PROMs is difficult to assess
because we do not have details of how many
PROMs questionnaires were sent out and how many
were returned.
Amongst those NJR cases for whom we had PROMs
entries, we checked whether those who had available/
complete measures at Q2 tended to have higher or
lower scores at Q1; we found that the 02 completers
tended to have had better scores at Q1, as seen in
Table 3.30. It may be that some of the initially less
healthy group had died in the interim; this will be
explored later.
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DEMO-00085-00189
Table 3.30 Bias in Q2 completion of EQ-5D Index, EQ-5D Health Scale (VAS), Oxford Hip Score.
0.516 (0.055 to 0.656)
0.159 (-0.016 to 0.620)
P<0.001'
92,133
18(12-24)
30,872
15(10-22)
P<0.001'
*Marin-Whitney U-test
Completion rates for both EQ-5D Index and EQ-5.D
Health Scale (VAS) tended to be slightly higher
in men than in women at both 01 and Q2. The
differences, although 'statistically significant', were
in fact very small (e.g. for VAS at 0 1 : completion
rates were 91.5% versus 89.3%, respectively, for
men and women).
All hip sub-groups showed significant improvement in
EQ-5D Index (Table 3.31).
Significant improvements from Q1 to 0 2 were seen
in all three health measures overall (see Tables 3.31
to 3.33).
All the main sub-groups showed improvements in the
VAS (Table 3.32) and in the Oxford Hip Score
(Table 3.33).
Histograms showing comparative distributions of
EQ-5D Scale (VAS) and Oxford Hip Scores at Q1
and 0 2 for complete pairs are shown in Figures 3.8
and 3.9 respectively.
Table 3.31 Changes in LO-5D Index for hip primaries with index scores at both time points.
23,182
MoM
71
CoP
2,881
Others/unsure
889
0.293
(0.030-0.620)
0.516
(0.055-0.620)
0.516
I0.055-0.656i
0.516
(0.055-0.691)
0.779
(0.623-1)
0.805
(0.639-1)
0.796
(0.691-1)
0.848
(0.691-11
0.413
(0.159-0.694)
0.309
(0.159-0.633)
0.380
(0.177-0.697)
0,380
(0.192-0.6841
P<0.001
PwO.001
P<0.001
P<0.(X) I
Continued >
*Wilcoxori matched-pairs signed-ranks test and checked With isign test. "Sign test.
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DEMO-00085-00190
T a b l e 3.31 (continued)
0.260
(-0.003 to 0.620)
0.260
(-0.003 to 0.620)
0.209
(0.026-0.568)
CoP
Others/unsure
prfP
MoM
0.779
(0.620-1)
0.796
(0.620-1)
0.760
(0.587-0.908)
P
1,68/
0.587
(0.189-0.691)
1 10.743-11
0/113
(0.I '10-0.708)
0/113
(0.173-0.703)
P<.0.001
0/104
(0.202-0.6 i 3i
P=0.003
(P=0.002*1
0.309
(0.165-0.484)
P<0.001
SI
if
*Wilcoxon matched-pairs signed-rankstest and cheeked .".'ih sen !c
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DEMO-00085-00191
Tabie 3.32 Changes in LQ-5D Health Scale Sec e (VAS) for hip primaries with scores at both time points.
§1!
MoM
1,662
85
(75-90)
10
(0-20)
P<0.001
*Wilcoxon matched-pairs sigried-ranks test.
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DEMO-00085-00192
Table 3.33 Changes in Oxford Hip Score for hip primaries with scores at both time points.
P<0.001
*WilcoXon matched-pairs signed-ranks test.
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Fiqure 3,8
Histogram to compare the distributions of the .EQ-5D- Health Scale Score (VAS) between Q1 and Q2 in cases
with scores at both time points (n=8Q,394).
(i) At Q1
15,000
10,000
5,000
20
40
60
SO
100
Q1 EQ-5D HEALTH SCALE
Figure 3,8
Histogram to compare the distributions of the EQ-5D Health Scale Score (VAS) between Q1 and Q2 in
cases with scores at both time points (n=80,394),
^
M Q 2
15,000
10,000 -
5,000
100
Q2 EQ-5D HEALTH SCALE
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Figure 3.9
Histogram to compare the distributions of the Oxford Hip Score between Q1 and 02 in cases with scores at
both time points (n=.92.133).
(i) At 01
20,000
15,000
3
10,000
5,000 -
10
20
30
40
50
Q1 Oxford Hip Score
Figure 3.9
Histogram to compare the distributions of the Oxford Hip Score between Q1 and Q2 in cases with scores at
both time points (n=92,133).
(ii) At Q2
20,000
15,000
3
10,000
5,000 -
20
30
Q2 Oxford Hip Score
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3.5.4 PRQM's outcomes for primary
knee replacements
132,019 of the linked primary knee operations in NJR
had an associated PROMs entry; Q1 was complete in
99.7% of these and both Q1 and Q2 were complete
in 74.6%. The median (IQR) interval of time from
completion of Q1 to the primary operation was 0.56
months (IQR 0.20-1.22; n=86,908) and from primary
operation to completion of Q2 was 6.47 months (IQR
6.31 to 6.90; n=87,171).
Table 3.34 below shows the overall outcomes after
primary hip surgery.
Table 3.34 Overall outcomes after primary knee surgery.
Excellent
2 Very good
3 Good
4 Fair
5 Poor
21.962(22.7%)
1 Much better
2 A little better
68,510(70.8%)
17,127(17.7%)
3 About the same
A A little worse
5 Much worse
33,626(31.3%)
25,186(26.1%)
12.186(12.6%)
3,668 (3.8%)
4,901 (5.1%)
3,727 (3.8%)
2,577 (2.7%)
3,236 (3.3%)
93,646(96.7%!
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DEMO-00085-00196
Amongst these NJR cases for whom we have PROMs
entries, those who had available completed measures
at Q2 tended to have had better scores at Q1, see
Table 3.35 below. As for hips, it may be that some of
those with poorer scores at Q1 had died before the
Q2 assessment.
Table 3.35 Bias in 0 2 completion of EQ-5D index, EQ-5D Heaith Scale (VAS), Oxford Knee Score.
YCS
8.0306
0.587 (0.088-0.691)
No
36,451
0.264 (0.055-0.691)
p<o.ooiSSS
„
,r-r- c,r>
§
^
CD
^
(0 [oo-80j +-
70(50-80)
„
. . .
2
to
p<o.oor
s
*Mann-Whitney U-test
Completion rates.for all three health measures, at
both 0 1 and Q2, tended to be slightly higher in men
than women; the differences, although 'statistically
significant' ,were very small (e.g. 99,0% vs 98.9%
respectively at Q1 and 73.5% vs 72.2% at Q2 for the
Oxford Knee Seore).
Significant improvements from 01 to 0 2 were seen in
all three heaith measures (see Tables 3.36 to 3.38).
All knee sub-groups showed significant improvement
in EG-5D Index (Table 3.36).
AHsub-groups except pate lio-fem oral showed small
improvements in VAS (Table 3.37).
Ail sub-groups showed improvements in the Oxford
Knee score (Table 3.38).
The distributions of EQ-5D Scaie (VAS) and Oxford
Knee Scores at Q1 and Q2 for complete pairs are
shown in Figures 3.10 and 3.11.
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DEMO-00085-00197
Table 3.36 Changes in L Q - 5 D index for knee primaries with index scores at both time points
Ail cemented
Ail uncemented
8 i .358
3,782
Ail hybrid
636
All patello-femora
257
All unicondylar
1,273
0.587
(0.088-0.691)
0.587
(Q. 101-0.691)
0.587
(0.101-0.691)
0.620
(0.124-0.691)
0.620
10.159-0.691 i
0.727
(0.620-0.883)
0.727
(0.620-0.848)
0.725
(0.587-0.349)
0.691
(0.516-0.796)
0.760
(0.620-1. OOO'i
0.280
(0.069-0.568)
0.240
(0.036-0.532)
0.240
(0.036-0.532)
0.105
(0.000-0.311)
0.240
(0.036-0.532'i
P<0.00
P<0.001
P<0.001
P<0.001
P<0.001
'Wilcoxon matched-pairs signed-ranks test and checked with sign test.
Table 3.37 Changes in EQ-5D Health Scale score (VAS) for knee primaries with scores at both time points.
All cemented
All uncemented
Ail hybrid
Ail patello-femoral
AH unicondylar
2
(-9 to 15)
*Wilcoxon matched-pairs signed-ranks test and checked with'sign test.
Table 3.38 Changes in Oxford Knee Score for knee primaries with scores at both time points.
a
Ail cemented
:r
*t
c
Ail uncemented
?
Ail hyhnc
^
Ail patello-femora
All unicondylar
'•"Wilcoxon matched-pairs signed-ranks test and checked with sign test.
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Figure 3.10
Histogram to compare the distributions of EQ-5D Health Scale Score (VAS) between Q1 and 02 in cases with
scores at both time points (n=84!G31).
(i) At Q1
15,000
10,000
5,000
40
60
100
Q1 EQ-5D HEALTH SCALE
Figure 3.10
Histogram to compare the distributions of EQ-5D Health Scale Score (VAS) between Q1 and Q2 in cases
with scores at both time points (n=84,Q31 )..
(il) At Q2
15,000
10,000
5,000
100
Q2 EQ-5D HEALTH SCALE
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DEMO-00085-00199
Fiqure 3,11
Histogram to compare the distributions of the Oxford Knee Score between 01 and 02 in cases with.scores
at both time points (n=93,353).
(i) At 01
6,000 -,
5,000
>.
-
4,000
o
c.
0)
t
3,000 -
IX
2,000
1,000
tt»ipaB«BttBB»«MiiM
10
20
mii«»
30
40
50
Q1 Oxford Knee Score
Figure 3.11
Histogram to compare the distributions of the Oxford Knee Score between Q1 and Q2 in cases with scores
at both time points (n=93,353).
(if) At Q2
6,000
5,000 -
>,
o
c
m
§"
4,000
nliiii
3,000
IX
2,000
"
1,000
SiS38Si5SlS§JSi8SS353l
10
20
30
40
50
Q2 Oxford Knee Score
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DEMO-00085-00200
3,5.5 Conclusions
Data linkage via HES allowed a match of PROMs data
to the subset of NJR records associated with English
patients who had had NHS funded primary hip or knee
replacement procedures (from the start of the collection
of PROMs in April 2009 until the end of the current
NJR annual report review period of 31 December
2012). Over a quarter of the identified orthopaedic
HES episodes were lost initially due to the absence of
a traceable NHS number. Of the remaining PROMs
records, between a quarter and 29% of this group of
English NHS funded primary hip/knee replacement
patients had only completed the pre-operation survey
and so we are unable to report on how this patient
group evaluated their quality of life post-operation. In
addition, based on the median responses (and IOR)
to Q1 for this sub-group compared to those who did
complete both surveys, these patients tended to be in
a poorer state of health prior to surgery. Therefore, in
interpreting the PROMs results for those patients who
completed both Q1 and Q2, it should be remembered
that these are patients who generally were healthier
prior to operation and would have a better prospect of
surviving to six months after the primary surgery. Thus,
pre- to post-operative changes in PROMs health scores
are likely to be less improved with the inclusion of the
less healthy pre-operative subset of patients lost to
follow up.
The vast majority of the 93,846 hip replacement
patients who had responded to both Q1 and Q2
indicated at least a 'fair' amount of satisfaction post
surgery (98.1 %) and over 85% of these reported
that the problems they had had living with their hip
condition before surgery were 'much better' after
receiving a hip implant.
It is clear that the hip patient group who completed
both Q2 and Q1 tended to be in a better state of
health before surgery than those who had only
completed Q1 (as indicated by higher scores on all
three health measures prior to operation for these;
most notably on the EQ-5D Index). Therefore, these
patients are more likeiy to have greater resilience
to undergoing surgery and are less likely to be
susceptible to complications post surgery. This group
reported a significant overall improvement in their
quality of life post surgeny. The median improvements
in score on the three health scales were 0.38 on the
EQ-5D Index, 10 points on the VAS score and 21
points on the Oxford Hip Score respectively.
In general, of the knee surgery patient group who
completed both questionnaires, most reported
enhanced lifestyle and health benefits post operation.
Operation outcomes were rated as a success overali,
although the proportion of those who were at least
satisfied with the outcomes were lower than the
ratings for hip surgery on the same items. That is,
more than 96% of knee patients with responses to
both Q1 and Q2 said they were at least fairly satisfied
with the results of their surgery. In addition, just over
70% of these patients intimated that the problems
they were faced with at circa six months post surgery
as a result of their knee condition were 'much better'
having had knee surgery.
As noted already for the hip patient group, the knee
patient surgical group who had completed both
surveys tended to have higher scores at Q1 and thus
were in better health overall compared to the group of
Q1 only respondees.
Across all knee surgery cases, for the three knee
PROMs measures of interest here, there was marked
improvement in patient self-reported well-being and
health post operation. This was seen as a general
increase in median scores and IQR values after
surgery i.e. responses to Q2 only and in the median
change in Q1 and 0 2 knee health scores of 0.275
on the EQ-5D Index, 3 points on the VAS score and
16 points on the Oxford Knee Score respectively.
However, the VAS score increase overall was more
moderate than for the other two measures.
The median score change was fairly consistent across
the main fixation and knee replacement type subgroups apart from for those undergoing a patellofemoral type knee surgery. Here, the change in health
score ratings compared to the other types of main
knee replacement types suggested that post-surgery
benefits to health and lifestyle were slightly less
improved than for other types of knee replacements.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
JEWELL 24 3
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00202
National Jofrtt Registry for England, Wales and No?
Part Four shows indicators for hip and knee joint
replacement procedures by unit and Trust. This
section was first included last year and has been
updated as part of the Government's transparency
agenda. It is based on procedures carried out during
the 2012 calendar year and submitted to the NJR by
28 February 2013.
Part Four information is based on the actual operation
date (1 January to 31 December 2012) whereas
data in Part One is based on the date the procedure
was submitted (1 April 2012 to 31 March 2013).
It is therefore possible for a hospital to have zero
submissions in Part Four but not be listed as a nil
returner in Part One.
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JEWELL 2 44
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00203
JEWELL 24 5
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00204
Unit outlier analysis covers the period from
1 April 2003 to 31 December 2012.
The outlier analyses made use of funnel plots from
statistical process control methodology. These aim to
distinguish normal variation between units (which is to
be expected) from unusual differences (termed 'special
cause' variation), which may indicate the need for further
investigation. Funnel plots enable units of different sizes
to be compared; performance indicators based on
smaller numbers of patients will have greater variability
and this in turn is reflected by wider control limits.
much more extreme, i.e. above the upper limit of the
99.99% control limits.
Previous annual reports have discussed in detail how
metal-on-metal bearing surfaces are associated with
higher revision rates than other bearing surfaces. Many
of the outlying hip units identified from this analysis
have more commonly used stemmed metal-on-metal
and resurfacing procedures, and although use of these
implants has now almost ceased in the UK, the higher
revision rates for these implants are likely to be reflected
in the returns, made by these units for some years to
come. This may explain their higher revision rates.
Summary of the methodology for unit revision rates:
* The standardised revision ratio (SRR) is plotted against
the number of expected revisions. The SRR is the total
number of revisions divided by the number of expected
revisions for that unit's caseload in respect of the age
group, gender, and the diagnosis of the patients, if the
SRR is 1, the number of revisions is compatible with
the number expected for that unit.
* Control limits for funnel plots are normally set at 95%
and 99.8% (roughly equivalent to 2 or 3 standard
deviations). Our normal six-monthly review process
focuses on those above the upper limit of the latter;
one might expect, however, that one in 500 would
be outside the 99.8% limits (above or below) just by
chance. In the table below we have highlighted in light
red (1) units above the upper limit of the 99.8% control
limits but also indicate in dark red (2) those that are
Summary of the methodology for unit 90-day
mortality rates:
* The standardised mortality ratio (SMR) is plotted
against number of expected deaths. The SMR is the
number of actual deaths within 90 days of primary
joint replacement divided by the number of expected
deaths in this period. The number of expected deaths
has been calculated after adjustment for patient
characteristics (age, gender, and ASA grade of
patients). In addition, for hip units, adjustment is made
for whether the operation was undertaken for trauma.
* Control limits are as for revisions above.
Any units identified as potential outliers in Part Four
have been notified. All units are provided with an Annual
Clinical Report and additionally have access to an online
NJR Management Feedback system (See section 1.4.6).
Please note for the data in following table:
Compliance, Consent and Linkability are:
H H H Red if lower than 80%.
I l l l l l Amber if equal to or greater than 80% and lower than 95%
iHHH Green if 95% or more
*
*
*
Compliance figures may be low due to delayed data entry
Linkability for some hospitals will be lower than expected if they have private patients from outside England and Wales
Part Four data covers procedures carried out between 1 January 2012 and 31 December 2012
Outlier analyses, are:
j!j!j!j!j!;:;:;:;!ij!ji Light red if units are outside 99.8% control limits (approx 3 standard deviations (SDs))
H H H Dark red if units are outside 99.99% control limits
The table uses the following footnotes:
23. Compliance (NHS Trust/Local Health Board Only) - the percentage of cases submitted to the NJR compared to HES/PEDW.
24. Consent Rate - percentage of cases submitted to the NJR with patient consent confirmed.
25. Linkability - the proportion of records which include a valid patient's NHS number compared with the number of procedures recorded on the NJR.
26. Outliers with respect to 90-day mortality following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs)
are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
27. Outliers with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3
SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00206
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26
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27
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24
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© National Joint Registry 2013
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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JEWELL 24 9
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00208
Compliance (NHS Trust/Local Healtn Board Only) - the percentage of cases submitted to the NJR compared to HES/PEDW.
Consent Rate - percentage of cases submitted to the NJR with patient consent confirmed
Linkabintv - the proportion of records whicn include a valid patent's NHS number compared with the number of piocedures recorded on tne NJR.
Outliers 'with rescectto90-day mortality foiiowing primary operations performed from 2003onwaids. Units outside 99.8% control limits (approx 3 SDsi are flagged in light red M); these outside 99.99 % control limits are flagged >n darkiec (2i.
Outiieis with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (appiox 3 SDs) are flagged in light redd); those outside 99.99% ccntioi iimits are flagged in dark red (2i.
© National Joint Registry 2013
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00210
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© National Joint Registry 2013
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00212
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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26
Outliers with respect to 90-day mortality foiiowing primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
27
Outliers with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
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Compliance (NHS Trust/Local Healtn Board Only) - the percentage of cases submitted to the NJR compared to HES/PEDW.
Consent Rate - percentage of cases submitted to the NJR with patient consent confirmed
Linkabintv - the proportion of records whicn include a valid patent's NHS number compared with the number of piocedures recorded on tne NJR.
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Outiieis with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (appiox 3 SDs) are flagged in light redd); those outside 99.99% ccntioi iimits are flagged in dark red (2i.
© National Joint Registry 2013
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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DEMO-00085-00218
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Consent Rate - percentage of cases submitted to the NJR with patient consent confirmed
Linkability - the proportion of records which include a valid patient's NHS number compared with the number of procedures recorded on the NJR.
26
Outliers with respect to 90-day mortality foiiowing primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
27
Outliers with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
24
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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DEMO-00085-00220
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Outliers 'with r e s o e c t t o 9 0 - d a y mortality foiiowing primary operations performed from 2 0 0 3 o n w a i d s . Units outside 9 9 . 8 % control limits lappiox 3 SDs) are flagged in light red M); these outside 99.99% control limits are flagged >n d a r k i e c (2i.
OutNeis with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 9 9 . 8 % control limits (appiox 3 SDs) are flagged in light r e d d ) ; those outside 99.99% ccntioi iimits are flagged in dark red (2i.
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-GQ085-0G222
Asoen Hea?'ica"e L^'iitBd
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3
Compliance (NHS Trust/Local Health Board Only) - the percentage of cases submitted to the NJR compared to HES/PEDW.
Consent Rate - percentage of cases submitted to the NJR with patient consent confirmed
Linkabiiity - the proportion of records which include a valid patient's NHS number compared with the number of procedures recorded on the NJR.
5
Outliers with respect to 90-day mortality foiiowing primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are
n dark red (2).
r
Outliers with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
4
3
© National Joint Registry 2013
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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JEWELL 2 65
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00224
BMI Tree S ' res Hosp_a
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5
Outliers with respect to 90-day mortality foiiowing primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are
n dark red (2).
r
Outliers with respect to revisions (at any time) following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
4
3
© National Joint Registry 2013
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00226
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00228
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Regency Hospital
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Linkability - the proportion of records which include a valid patient s NHS number comoared with the number of procedures recorded on the NJR.
26
Outliers with respect to 90-day mortality foiiowing primary operations performed from 2003 onwaids Unto outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
27
Outliers with respect to revisions (at any time) following primary operations performed from 2003 onwards Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits are flagged in dark red (2).
24
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00230
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Shepton Mallet I reatment Centre
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Compliance, Consent and Linkability are:
V^m
Red if lower than 80%
Amber if equal to or greater than 80% and lower than 95%
Hf Green if 95% or more
* Compliance figures may be low due to delayed data entry
•'• Linkability for some hospitals will be lower than expected if they have private patients from outside England and Wales
* Part Four data covers procedures carried out between 1 January 2012 and 31 December 2012
Outlier analyses are:
llllll
Light red if units are outside 99.8% control limits (approx 3 standard deviations (SDs))
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5
Outliers with respect to 90-day mortality following primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged In light red (1); those outside 99,.99% control limits are flagged in dark red (2).
r
Outliers with respect to revisions (at any time) foiiowing primary operations performed from 2003 onwards. Units outside 99.8% control limits (approx 3 SDs) are flagged in light red (1); those outside 99.99% control limits eire flagged in dark red (2).
4
3
' National Joint Registry 2013
w
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KS
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
JEWELL 2 7 3
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
DEMO-00085-00232
Acetaouiar component
i ne portion or a total nip replacement prosthesis tnat is inserted into tne acetabulum - the socKet part ot
a ball and socket joint,
iiji^t^i^aGeiig:;:;:;:;:;:;:;:;:;:;:;:
Acetabular prosthesis
riAjSibiotichlroa^
See Acetabular component.
fSeerieemeM
A procedure where the bones of a natural joint are fused together {stiffened).
Arthrodesis
iijSijjpji^i^
ABHI
Association of British Healthcare Industries - the UK trade association of medical device suppliers.
illSiWibairiri
lipsfghiiaSiiEoiiip^
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rlj|e::SShe^©ritrhg:i^;i;^
Bearing type
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The two surfaces that articulate together in a joint replacement. .Options include
metal-on-polyethylene, metai-on-metal, ceramic-on-polyethyiene, ceramie-on-metal and ceramic-onceramic.
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BMI
Body mass index. A.statistical too! used toestimate a healthy body weight based on an individual's
height. The BMI is calculated by dividing a person's weight (kg) by the square of their height{m2).
Bone: cement
See cement.
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CQC
Care Quality Commission. Regulators of care provided bylhe NHS, local authorities,, private-companies
and voluntary organisations.
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Case mix
Term used to describe variation in surgical practice, relating to factors such as indications for surgery,
patient age and gender.
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Prostheses designed to be fixed into the bone using cement.
Cemented
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Compliance
The percentage of ail total joint procedures that have been entered into the NJR within any given period
compared with the expected number of procedures performed. The expected number of procedures
can be the number of levies returned, or for the NHS Sector only; the number of procedures submitted
to HES and PEDW.
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Confidence Interval {CI)
A confidence interval (Gl) gives an estimated range of values which is likely to include the unknown
population parameter {e.g. a revision rate) being estimated from' the given sample. If independent
samples are taken repeatedly from the same population, and a confidence interval calculated- for each
sample, then a certain percentage (confidence level: e.g. 95%) of the intervals will include the unknown
population parameter.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
Confounding
Systematic variation oue to the presence of factors not on the causal pathway, which affect the
outcome, which are unequally distributed amongst interventions being compared whicn leads to
inaccurate inferences about the lesufts.
Cox proportional hazards model
A serni-parametnc survival analysis model commonly used to model time-to-event data as it does
not require the underlying hazard function to take a particular shape. As it is a multi-variable model, it
can be used to explore The effects of covariates on the outcome of interest and reduce the impact of
confounding.
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•rree. aoxe eloow. ano sho..ce'n-c•cec.mesunce'"a-<e••, oerwee I Ja-.mvano 31 Decemoe'20l2
rciusi-'O- Ino 2012 oalonoaryoai Toe N.iR A-"-\,a Ronor. Par T-'-oo opo Is on " p, moo and ank o
on.
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2012.
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socke: {aoe1ab:.r..mji'w"oh may cause --sraoi :y.
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Femoral component (hip)'
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Part of a total hip joint that'Is inserted into the femur (thigh hone) of the
stem and head (ball).
patient. It normally consists of a
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Femoral head
Spherical portion of thefemorai component of the artificial hip replacement.
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Femoral stem
The part of a modular femoral component inserted into the femur (thigh bone). Has a femoral head
mounted on It to form the complete femoral'component.
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Funnel plot
Glenoid-componen
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A graph of a performance measure for eaeh unit plotted against the unit's number of oases. Control
limits are shown to indicate acceptable performance.
The: portion of a total shoulder replacement prosthesis that is inserted into the scapula - the socket
part of a bait and socket joint in conventional shoulder replacement or the ball part in reverse shoulder
replacement.
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Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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See Feme-a noad a'd/ci I iumo a nead.
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Hospital Episode Statistics, Data on case mix, procedures, length of stay and other hospital statistics
collected routinely by NHS hospitalsin' England.
HES
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Humeral component (elbow)
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Part of a total elbow:joint that is inserted into the humerus (upper arm bone) of the' patient to replace the
articulating surface of the humerus.
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Humeral cup
The shallow socket of a reverse shoulder replacement attached to the scapula.
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Humeral prosthesis
Portion of a total joint replacement used to replace damaged parts of the humerus (upper arm bone).
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Hybrid procedure
Joint replacement procedure in which cement Is used to fix one prosthetic component while the other
is cementless. For hip procedures, the term hybrid covers both reverse hybrid (cementiess stern,
cemented socket) and hybrid (cemented stem, cementless socket).
Image/computer-gujded surgery
Surgery performed by the surgeon, using real-time images and data computed from these to assist
alignment and positioning of prosthetic components.
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The primary joint replacement that is the subject of an NJR enty.
Index joint
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ISTG
independent sector treatment centre (see Treatment centre).
Kaplan-Meier
Estimates of the cumulative pmbabi ity of failure (revision or death) that properly take nto account
'censored' daia. Censorings arise Tom incomplete follow up; for revision, for example, a patient may
hrj
ve died or reached the end the analysis period (end ot2012) without having been revised. The
timates do not adjust for any confounding facto-s
Lateral resurfacing (elbow)
Partial resurfacing of the elbow, with, a humeral surface, replacement component used with a lateral
resurfacing head inserted with or without cement.
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Linkabie percentage
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Linked total eibow
Linkabie percentage is the percentage of ail relevant procedures that have been entered into the NJR,
which may be linked via NHS number to. other procedures performed on the same patient..
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Where the humeral and ulnar parts of a total elbow replacement are physically connected.
Source: https://www.industrydocuments.ucsf.edu/docs/yywn0226
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Low rholecular weight Heparin. A blood-thinning drug used in the prevention and treatment of deep vein
(i.e. they must be filled in). Fields thai relate to patients' personal details must oniy be completed where
informed patient consent has been obtained.
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MDS2(MDSv2)
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MDS4(MDSv4)
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Minimum dataset version two, introduced on 1. April 2004. MDS2 replaced MDS 1 as the official data
set on 1 June 2004.
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Minimum dataset version four, introduced on 1 April 2010 replacing MDS 3 as the new official dataset.
This, dataset has the same hip.and knee MDS 3 dataset but includes the data collection for total ankle
replacement procedures.
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MHRA
Medicines and Healthcare products Regulatory Agency -the UK regulatory body for medical devices.
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Mixing and matching
Also Known as 'cross breeding'. Hip replacement procedure in which a surgeon chooses to implant a
femoral component from one manufacturer with an acetabular component from another.
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moo..arc..'"J me . or 'emo a s.cm c c a e d v.i.n a iemcra heao.
Monoboc
ComoonenT composes of or supo eo as. one peea e.g. a monoooo knee T aa romoorer.-.
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NHS
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NICE
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NJR
Na.ior-ai Jci u Reg shy c Cngianc. Waios a ic No .he r Ida IC. Tw NJR has coicc.ee afo analysed
cam o-i mo ano K"ee-eoacements since | Aori 2003. on ?r <le reoiaremenTS s nee I And 2010
anc on ooow "cpacenen.sanc suoudc rcaiacomon.s si ire ApH 2012. I. co-.-c s oo.h !m Ni IS afo
inccpcndc-"'. -ica .hcac scc.ors .ocmurccompc.c rocod^g o' "a.iona actv.y in E-igiafo. Wales anc
Nohm-forea-d.
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Ohnooaec c Data Eva „a: on Race! ofohe NHS Supoy Gha n. www.ccep.org.uk
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JEWELL 2 77
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DEMO-00085-00236
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OPGS-4
Office of Population, Censuses and Surveys: Classification of Surgical Operations and Procedures, 4th
Revision - a list of surgical procedures and-codes.
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Pantalar (ankle)
Affecting the whole talus, i.e. the ankie (tibio talar) joint, the subtalar (talo calcaneal) joint and the:
talonavicular joint.
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Pateilo-femoral knee
Procedure involving replacement o f t h e trochlear and replacement resurfacing of the patella.
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Patient consent
Patient personal details may only be submitted to the NJR where explicit informed patient consent has
been given or where patient consent has not been recorded. If a patient declines to give consent, only
the anonymous operation and implant data may be submitted.
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Patient procedure
lype-o'f procedure carried out on a patient, e.g. primary total prosthetic replacement using cement.
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PDS
The NHS Personal Demographics Service is the national electronic database of NHS patient
demographic details. The NJR uses the PDS Demographic Batch Service (DBS) to source missing NHS
numbers ana to determine when patients recorded on the NJR have dieo.
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Poisson distribution
This distribution expresses the probability of a number of reiativeiy rare events occurring in a fixed time if
these events occur with a known average rate and are independent ofthe time since the last event. It is
a special case of the binomial distribution in that it models discrete events.
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Prosthesis
Orthopaedic implant used in joint replacement procedures, e.g. a total hip, a unicondylar knee, a total
ankle, a reverse shoulder or a radial head replacement.
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" tient-Time Incidence Rate. I his is the rate of occurrences of an event (i.e. revision) for a given total
ie at risk.
Radiai head component (elbow)
Part of a parfia! elbow joint that is inserted into the radius (outer lower arm bone) of the patient to
replace the articulating surface of the radial head. May be mohobloc or modular.
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Resurfacing (shoulder)
Resurfacing of the humeral head with a surface replacement humeral prosthesis inserted, with or
without cement.
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Revision burden
The proportion of revision procedures carried out as a percentage of the total number of surgeries on
that particular joint.
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DEMO-00085-00237
Shoulder hemiarthroplasty
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Subtalar joint (ankle)
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Hepiacement ot tne numeral neap witn a numeral stem and nead orsnouider resurfacing component
which articulates with the natural glenoid.
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The joint between the talus and the calcaneum.
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Survivorship analysis
A statistical method that is used to determine what fraction' of a population, such as those'who have
had a particular hip implant, has survived unrevised past a certain time. See Kaplan-Meier.
Talar component
Portion of an ankie prosthesis that is used to replace the articuiating surface of the talusat the ankle
joint.
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TED stockings
Thrombo embolus deterrent (TED) stockings. Elasticised stockings that can be worn by patients
following surgery and which may help reduce the risk of deep vein thrombosis (DVTj.
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Thromboprophylaxis.
Drug or other post-operative regime prescribed to patients with the aim.of preventing blood, clot
formation, usually deep vein thrombosis (DVT), in the post-operative period,
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Tibial component (ankle)
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Portion of an ankie prosthesis that is used to replace the articulating surface of the-tibia (shin bone) at
the ankle joint.
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Total condylar knee
Type of knee prosthesis that replaces the complete contact area between the femur and the tibia of a
patient's knee.
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Trochanter
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Two-stage revision
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Ulnar component (elbow)
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Bony protuberance of the femur, found, on its upper outer aspect.
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A revision procedure-carried out as two operations, often used in the treatment of deep infection.
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Part of a total elbow joint that is inserted Into the ulna (Inner lower arm bone) of the patient to replace
the articulating surface of the ulna.. Maybe linked or unlinked.
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Unicondylar arthroplasty
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Unilateral operation
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Replacement of one tibial condyle and one femoral condyle in the knee, with or without resurfacing of
the patella.
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Operation performed on one side only, e.g. left hip.
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wwwjTJrcentre.org.ul'
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