11th Annual Report. HIPS KNEES ANKLES ELBOWS SHOULDERS PROMs. National Joint Registry for England, Wales and Northern Ireland

Transcription

1 HIPS KNEES ANKLES ELBOWS SHOULDERS PROMs 11th Annual Report 2014 National Joint Registry for England, Wales and Northern Ireland ISSN X (Online) Surgical data to 31 December 2013

2 Prepared by The NJR Editorial Board NJRSC Members Mick Borroff Michael Green Professor Paul Gregg Professor Alex MacGregor Mr Martyn Porter Mr Keith Tucker Nick Wishart NJR RCC Network Representatives Mr Colin Esler Mr Peter Howard Mr Alun John Mr Matthew Porteous Orthopaedic Specialists Mr Andy Goldberg NJR Research Fellows Mr Jeya Palan Healthcare Quality Improvement Partnership NJR Management Team and NJR Communications Rebecca Beaumont James Thornton Elaine Young Northgate Information Solutions (UK) Ltd NJR Centre, IT and data management Victoria McCormack Anita Mistry Dr Claire Newell Dr Martin Pickford Martin Royall Mike Swanson University of Bristol NJR Statistical support, analysis and research team Professor Yoav Ben Shlomo Professor Ashley Blom Dr Emma Clark Professor Paul Dieppe Dr Linda Hunt Garry King Dr Michèle Smith Professor Jon Tobias Pad Creative Ltd (design and production) This document is available in PDF format for download from the NJR Reports website at Additional data and information can also be found as outlined on page 16. This document is available in PDF format for download from the NJR website at

3 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Contents Chairman s introduction 8 Foreword from the Chairman of the Editorial Board 10 Executive summary 12 Part 1: Annual progress...13 Part 2: Clinical activity Additional information on the NJR Reports website...16 Part 3: Outcomes after joint replacement 2003 to Part 4: Trust-, Local Health Board- and unit-level activity and outcomes Part 3 Outcomes after joint replacement 2003 to Summary of data sources and linkage Outcomes after primary hip replacement Overview of primary hip surgery Revisions after primary hip surgery Revision after hip surgery with a competing risk of death Revisions after primary hip surgery for the main stem-cup brand combinations Revisions for different causes after primary hip surgery Mortality after primary hip surgery In-depth study: Short-term mortality after hip replacement Conclusions Outcomes after primary knee replacement Overview of primary knee surgery Revisions after primary knee surgery Mortality after primary knee surgery In-depth study: Short-term mortality following primary knee surgery Conclusions Outcomes after primary ankle replacement Overview of primary ankle surgery Revisions after primary ankle surgery Mortality after primary ankle surgery

4 Part 3 tables Table 3.1 Summary description of datasets used for survivorship analysis...24 Table 3.2 Composition of person-level datasets for survivorship analysis...25 Table 3.3 Table 3.4 Numbers and percentage of primary hip replacements of each type of fixation and within each fixation sub-group, by bearing surface...28 Percentages of primary hip replacements in each calendar year that use each fixation type and for each fixation group, the percentages within each bearing surface...29 Table 3.5 Distribution of consultant surgeon and unit caseload for each fixation type...32 Table 3.6 Table 3.7 Table 3.8 Table 3.9 Table 3.10 Table 3.11 Table 3.12 Table 3.13 Distribution of age at primary hip replacement (in years) and gender, for all procedures and for each type of fixation and bearing surface...33 Kaplan-Meier estimates of the cumulative percentage probability of revision (95% CI), by year from the primary operation, for all cases and by fixation and bearing surface...36 Kaplan-Meier estimates of the cumulative percentage probability of revision (95% CI), by gender and age, at 1, 3, 5, 7 and 10 years from the primary operation, for each fixation group and main bearing surface...43 Kaplan-Meier estimates of the cumulative percentage probability of revision (95% CI) at 1, 3, 5, 7 and 10 years after the primary operation, for the most commonly used cup-stem brand combinations (group sizes >2500, or >1,000 in the case of resurfacings)...49 Kaplan-Meier estimates of the cumulative percentage probability of revision (95% CI) at 1, 3, 5, 7 and 10 years after the primary operation for the most commonly used cup-stem brand combinations (group size >10,000) with further subdivision by main bearing surface; results are shown only for the bearing surface sub-groups with >1,000 procedures...51 Revision rates for each indication, expressed as numbers per 1,000 patient-years (95% CIs), for all cases and by fixation and bearing surface...54 Revision rates for each indication, expressed as numbers per 1,000 patient-years, overall and by time interval from primary operation...56 Kaplan-Meier estimates of the cumulative percentage mortality (95% CI), at different time points after primary operation, for all cases and by age/gender Table L1 90 day mortality by age and gender...62 Table L2 Changes in mortality over time...63 Table L3 Univariable and multivariable analyses...65 Table L4 Additional multivariable models...67 Table L5 Change in the use of thromboprophylaxis with time...69 Table L6 Change in the use of spinal anaesthesia with time...69 Table L7 Charlson comorbidities found in HES in the 5 year period prior to the primary operation...70 Table L8 Results from imputation models for BMI...71 Table 3.14 Numbers and percentage of primary knee replacements by fixation method and bearing type

5 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Table 3.15 Percentage of all primary knee replacements performed each year by method of fixation and within each method of fixation, the percentage breakdown of each bearing type...79 Table 3.16 Distribution of consultant surgeon and unit caseload for each fixation type...80 Table 3.17 Table 3.18 (a) Table 3.18 (b) Table 3.19 Table 3.20 Table 3.21 Table 3.22 Table 3.23 Table 3.24 Table 3.25 Age (in years) and percentage male at primary operation for different types of knee replacement; by fixation and bearing type...81 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...91 Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) at specified times after primary knee replacement, by age and gender, for each fixation and bearing group...93 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...99 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 each fixation/bearing surface sub-group Revision rates (95% CI) broken down by time period in which primary was revised, expressed as number of revisions per 1,000 patient-years, for each recorded reason for first knee revision Kaplan-Meier estimated cumulative percentage probability of first revision (95% CI) of a primary total knee replacement by main type of implant brand at the indicated number of years after primary operation Kaplan-Meier estimates of the cumulative percentage probability of first revision (95% CI) of a primary unicompartmental knee replacement by main type of implant brand at the indicated number of years after primary operation 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 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 by age group and gender Table L9 45-day mortality by age and gender Table L10 Changes in mortality by year of primary operation Table L11 Cox proportional hazards models of 45-day mortality Table 3.26 Numbers of primary ankles by ankle brand Table 3.27 Indications for the 29 (first) revisions following primary ankle replacement Table 3.28 Kaplan-Meier estimates of the cumulative percentage mortality (95% CI), by gender and age, at 90 days and 1, 2 and 3 years from the primary operation

6 Part 3 figures Figure 3.1 Temporal changes in percentages of each fixation method used in primary hip replacements...30 Figure 3.2 Figure 3.3 Figure 3.4 Figure 3.5 Figure 3.6 Figure 3.7 Figure 3.8 Figure 3.9 Figure 3.10 Temporal changes in percentages of each bearing surface used in (a) cemented, (b) uncemented, (c) hybrid and (d) reverse hybrid primary hip replacements...30 Temporal changes in revision rates: Kaplan-Meier estimates of cumulative percentage probability of revision for (a) each year of primary operation and (b) over the first three years...34 Comparison of cumulative probability of revision (Kaplan-Meier estimates) for cemented hips with different bearing surfaces...37 Comparison of cumulative probability of revision (Kaplan-Meier estimates) for uncemented hips with different bearing surfaces Comparison of cumulative probability of revision (Kaplan-Meier estimates) for hybrid hips with different bearing surfaces...39 Comparison of cumulative probability of revision (Kaplan-Meier estimates) for reverse hybrid hips with different bearing surfaces...40 Cumulative probability of revision (Kaplan-Meier) for the whole cohort of hips broken down by (a) age at primary and (b) age separately for each gender Comparisons between Kaplan-Meier estimates for revision (solid lines) and cumulative incidence function (CIF, dashed lines) which makes adjustment for the competing risk of death; separate comparions are made for age groups <55, 55-64, and 75+ years at primary operation...48 Change in PTIR with time from operation, for (a) aseptic loosening, (b) pain, (c) dislocation/subluxation and (d) infection for selected fixation/bearing sub-groups...57 Figure L1 Graph of the smoothed hazard rate showing how the risk of death changed over the first 90 days...62 Figure L2 Changes in mortality over time...63 Figure 3.11 Figure 3.12 Figure 3.13 Changes in cumulative percentage chance of implant failure by year of primary operation. Kaplan-Meier estimates of cumulative percentage probability of a first revision grouped by year in which primary surgery took place. Figure 3.11 (a) depicts revision rates over the whole period 2003 to 2013, Figure 3.11 (b) revision rates for the first three years post-surgery...83 Kaplan-Meier estimates of the cumulative percentage probability of a first revision of primary knee replacement broken down by (a) age group and (b) age group and gender at increasing years after the primary surgery...85 Comparison of the Kaplan-Meier cumulative percentage probability estimates of a knee prosthesis first revision for different bearing types at increasing years after the primary surgery when the primary arthroplasty method of fixation is (a) cemented only, (b) uncemented or hybrid and (c) unicondylar and patello-femoral

7 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Figure 3.14 Comparison of the Kaplan-Meier estimates versus the Cumulative Incidence Function (CIF) estimation of the cumulative percentage probability of first revision with adjustment for the competing risk of death at increasing time after primary surgery. Separate graphs are shown for males and females and the cumulative percentage probability of first revision estimates shown are subdivided by age group within each gender category Figure L3 Graph of the smoothed hazard rate showing how the risk of death changed over the first 90 days Figure L4 Changes in 45-day mortality over time Glossary Glossary

8 Chairman s introduction Laurel Powers-Freeling Once again it is my pleasure as Chairman of the National Joint Registry Steering Committee (NJRSC), to introduce our 11th Annual Report, which outlines the substantial progress and work of the NJR during the year 2013/14. This is also the first year of the roll-out of new digital annual reporting arrangements and the launch of a new NJR Reports website. This year has been particularly exciting as we have celebrated the 10th anniversary of the NJR, with a number of stakeholder events held throughout the year. These provided an opportunity to showcase the many achievements of the registry, which has grown to be the largest of its kind in the world since its inception more than ten years ago. There have been a number of changes to the membership of the NJRSC with the expiry of a number of member terms of office. I would therefore, like to take the opportunity to acknowledge the significant contributions made by those outgoing members for their work in having made the NJR the successful and world-leading registry it is today. Professor Alex MacGregor, epidemiology representative (since 2002) and Chairman of the NJR Research Sub-committee, Mick Borroff, industry representative (since 2003), and Andrew Woodhead, NHS management representative (since 2007), have each been highly dedicated to the NJR and provided valuable input to our various allimportant sub-committees. Specifically, I would like to record special thanks to Professor Paul Gregg, NJRSC Vice Chairman and surgeon member, who since his appointment in 2002, has been instrumental in the development of the NJR. Notably, this has been through Chairmanship of the Surgeon Outlier and Data Quality Sub-committees as well as his leadership in these important areas. In turn, a number of new NJRSC appointments have been made and I am delighted to welcome Martyn Porter, previously a surgeon member, to the new post of NJR Medical Director and Vice Chairman; Professor Mark Wilkinson, as epidemiology representative and Research Sub-committee Chairman; Nicholas Wishart and Michael Green as industry representatives; Rob Hurd as NHS management representative; and Professor Andrew Price and Peter Howard (previously Chairman of the RCC Network and co-opted surgeon member), as surgeon representatives. I also welcome the additional co-opted membership of the British Orthopaedic Association (BOA) President, currently Professor Tim Briggs, to signify greater collaboration between the NJR and the orthopaedic surgical profession. This will be further strengthened in 2014/15, with the establishment of the new Medical Advisory Committee and greater involvement of the specialist orthopaedic societies in the work of the sub-committees. We are proud to announce some key developments and achievements during the course of the review year. These include giving greater transparency to our work aims through the publication of a number of strategic documents, namely a three-year Strategic Plan 2013 to 2016, a supporting annual work plan and a communications strategy. Work also started on the production of a data quality strategy and a research strategy. These two key documents will be published during the coming year 2014/15 and will set out our proposals for addressing these priority areas of work. A major change to our operating arrangements involved reviewing the NJR economic model, with the aim of reducing costs to the NHS and independent sector through revising the levy collection and securing a fair and proportionate contribution from orthopaedic device manufacturers as key NJR stakeholders. Work was ongoing throughout the year and from April 2014 new arrangements are to be implemented which will see the cost of the NJR levy reduce from 20 to gross per procedure, representing a significant saving to healthcare providers. 8

9 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Associated with these economic changes, we continued work with the Department of Health (DH) and the QIPP Orthopaedic Procurement Group, to evaluate the results of the price benchmarking pilot study. This has demonstrated the enormous benefit of this initiative and has generated considerable interest with those surgeons and providers involved in the pilot, given the potential to achieve significant savings through analysis of price and usage of orthopaedic implant devices. It is exciting to be able to confirm that from April 2014, price benchmarking will be rolled out nationally as a new NJR service available to all NHS organisations; with online reporting services available to NHS procurement teams. Following the first publication of individual consultant outcomes in July 2013, work has continued with the BOA to develop the range of quality indicators available for publication in 2014/15. It has now been agreed that in September 2014 the NJR will extend published information on individual surgeons to include 12-month and 36-month profiles for hip, knee, ankle, elbow and shoulder surgeons as well as the use of ODEP-rated prostheses for hip replacement. An important step forward for 2014 will be a formal data validation period in which surgeons and hospitals will be able to validate the data for publication against these indicators. This year the NJR has worked closely with the DH to create a new best practice tariff for primary hip and knee replacement. For 2014/15, the tariff will be linked to two NJR indicators compliance and consent. We welcome this development, which will ensure improved quality of data reporting to the NJR, as well as raising the profile of the registry with healthcare commissioners. NJR PROMs continued with distribution early in the year of the three-year PROMs questionnaires. Analysis of feedback is planned to continue during 2014/15. As the largest arthroplasty registry in the world, we continue to collaborate internationally, making presentations at both the International Consortium of Orthopaedic Registries and International Society of Arthroplasty Registries (ISAR) conferences and working with colleagues from other national registries. The most significant initiative currently ongoing is probably the introduction of Unique Device Identifiers, which is being pursued within the NJR, together with the complementary opportunities to improve our component database. Also from April 2014, NJR Medical Director, Martyn Porter, will become President of ISAR, which will present an increased opportunity for NJR international involvement. Additional plans for the 2014/15 operating year include: Development of the NJR Clinician Feedback System to provide an improved reporting format to aid surgeon appraisal, revalidation and validation of data Continued development of the NJR Patient Network and involvement of patients in sub-committee activity Evaluation of a patient implant card pilot Evaluation of a two-year shoulder PROMs pilot While I gave my thanks to colleagues who had stepped down from the NJRSC at the beginning of this introduction, I would also like to mention all remaining members of the NJRSC and NJR Sub-committees for their valuable contribution. In particular the chairmen of those committees: Paul Gregg again for his leadership of the Outlier and Data Quality Sub-committees; Keith Tucker, who chaired the NJR Implant Performance and Scrutiny Sub-committee; Martyn Porter, who chaired the Editorial Board (and oversaw the preparation of this report); and Professor Alex McGregor, who chaired the NJR Research Sub-committee. We are also grateful to Peter Howard for chairing the NJR Regional Clinical Coordinators Network and all the surgeons who participate as Regional Clinical Coordinators and underpin the success of the NJR with their support at local level. Finally, my thanks to the NJR contractors, Northgate Information Solutions (UK) Ltd, the University of Bristol and to all the management and communications team at the Healthcare Quality Improvement Partnership (HQIP), in particular Elaine Young, NJR Director of operations, for providing sound management of the NJR every day. Yours sincerely, Laurel Powers-Freeling Chairman, National Joint Registry Steering Committee 9

10 Foreword from the Chairman of the Editorial Board The NJR started collecting data in April 2003 and last year we reported up to ten years of clinical activity and outcomes analysis. The NJR now contains more than 1.6 million records and is growing with more than 200,000 cases submitted a year. The phenomenal success of joint replacement means that outcomes are measured over decades rather than years. As the reporting period of the NJR moves forward we will start to see important determinants that influence the outcome and longevity of the procedure. In the first ten years we unfortunately observed high failure rates of some resurfacings and total hip replacements used with a metal-on-metal articulation. Although the registry could not predict or indeed prevent these failures it was instrumental in detecting the size of the problem as it unraveled. By working in close partnership with the Medicines and Healthcare Products Regulatory Agency (MHRA) and the profession, the registry clearly influenced the regulatory actions and prevented further harm to patients. Patient safety is of paramount concern and the actions of the NJR influenced global regulatory responses. The NJR continues to observe a higher revision rate following partial knee replacement and isolated replacement of the patello-femoral joint. There may be other benefits to patients in carrying out some operations that have a higher re-operation rate. Still, it is essential to understand what these benefits are and to encourage the profession to optimise outcomes and fully engage the patient in the decision-making process. The data on other joint replacements including shoulder, elbow and ankle continues to evolve. Over the past decade, the NJR has grown into a sizeable organisation that engages with multiple stakeholders including patients, hospitals, surgeons, regulators and industry. The NJR provides comprehensive IT systems to ensure the relevant data is made available to these groups allowing them to make more informed decisions to benefit patient care and enhance patient safety. NJR data is also being used to facilitate service evaluation including procurement and a national review of orthopaedic services within England*. These initiatives have been sponsored by NHS England and demonstrate the value of high quality data in terms of evaluating and redesigning healthcare provision. Following the 2012 change in status of the NJR Steering Committee to an NHS England Committee of Experts, further structure and governance changes have ensued. This includes the establishment of the Medical Advisory Committee which will provide the necessary forum for effective clinical and professional engagement from the key professional groups particularly the British Orthopaedic Association, the British Hip Society, the British Association for Surgery of the Knee, the British Elbow and Shoulder Society and the British Orthopaedic Foot and Ankle Society. What are the key messages from this report? Firstly, that the data is complex and needs careful consideration. Registry data is observational but limited by confounding factors and limitations of follow-up. For example, the classic debate as to whether cemented fixation for hip replacement is better (or not) compared to uncemented fixation is almost redundant in that it depends on other factors such as patient age, gender, bearing surface and period of observation. For most patients, revision rates of less than 5% at ten years can be achieved. A number of different types of replacement and brand can have a similar performance suggesting that there may not be a best device and a number of devices have acceptably low *Getting it Right First Time:

11 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report revision rates and are safe for patients. The NJR has also identified patient groups and devices that have a statistically higher revision rate. Still, we are aware that revision is not the final arbiter of success or failure and that other factors including risk of death, function, patient reported outcomes and cost-effectiveness also need to be considered and evaluated. The main changes in this year s report relate to the inevitable transition to online reporting which increases functionality and access to data. This year the data previously contained in Part Two (descriptive information on activity and practice) will move to an interactive web-based service that allows more detailed individual enquiry. Expect further developments of this nature in years to come at Finally, I would like to thank everyone who has helped to make the NJR the success that it has become. Particularly to patients for consenting for their details to be recorded, surgeons for inputting their data and the whole NJR Editorial Board, NJR management team and contractors for their hard work and dedication. Martyn Porter Chairman, Editorial Board and NJR Medical Director 11

12 Executive summary

13 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Part 1: Annual progress The 11th Annual Report of the National Joint Registry for England, Wales and Northern Ireland (NJR) is the formal public report for the period 1 April 2013 to 31 March 2014 and comprises four distinct parts: Part One contains news and information about the progress of the NJR Part Two includes statistics on joint replacement activity for hip, knee, ankle, elbow and shoulder activity for the period 1 January to 31 December 2013 Part Three includes detailed statistical analysis on hip, knee and ankle joint replacement surgery using data from 1 April 2003 to 31 December 2013 and Part Four reports indicators for hip and knee joint replacement procedures by Trust, Local Health Board and unit based on the 2013 calendar year As part of a new approach to sharing information about NJR progress (Part One), clinical activity (Part Two) and hospital activity (Part Four), the National Joint Registry has a new, dedicated online annual report website NJR Reports to host and share all the NJR s annual report data and information. Some of the data can be found in this slimmer printed report namely the executive summary for each part of the NJR annual report data and the full detailed, statistical analysis of outcomes following joint replacement surgery (Part Three). A short summary of the NJR s progress over 2013/14 is included below, with further detail available at The total number of procedures recorded in the NJR exceeded 1.6 million at 31 March 2013, with 2013/14 having the highest ever annual number of submissions at 205,686. This is against a backdrop of general improvement in data quality, although a high degree of monitoring and support to orthopaedic units is still required: Overall compliance (case ascertainment) was recorded as 99.6% Patient consent (to record their details in the NJR) was recorded as 91.8% Linkability (the ability to link a patient s primary procedure to a revision procedure) was recorded as 95.1% Significant progress was made in the evolution of the NJR Steering Committee and its sub-committees in order to remain fit for purpose for the lifetime of the registry. In 2012/13, a key focus was a review of the registry s governance, structure and operating model. This year the structure has moved forward with a revised operating model, a series of appointments to the steering committee and establishment of a new Medical Director post. In recognition of the great increase in scope and responsibilities of the NJR, the strategic plan now includes the development of three additional strategies; research, data quality and communications to further support the delivery of its primary strategic themes; patient safety and outcomes, information availability and access to data and research. Another key achievement has been the work to establish a revised economic model from 1 April This not only represents a significant cost saving to the NHS but establishes a new, fair and proportionate cost contribution from orthopaedic device manufacturers for services provided through NJR Management Feedback to support post-market device surveillance. This model also includes provision of a new service to NHS procurement teams to enable review and benchmarking of implant price information against other providers. Collaboration with Beyond Compliance has continued, resulting in the service s launch which now provides a way of following up new implants on the UK market so their use and performance can be controlled and monitored much more closely. 13

14 International collaboration and the development of Unique Device Identifiers also progressed, with national collaboration focusing on supporting the Orthopaedic Data Evaluation Panel (ODEP) and the introduction of ODEP ratings for knee prostheses as well as the Getting It Right First Time initiative. It should also be highlighted, the reports from the respective Chairmen of the Implant Performance Subcommittee and the Surgeon Outlier Sub-committee are available online. These report how outlier analysis is undertaken and include the high-level outcomes of the monitoring process for 2013/14. The NJR remains committed to working for patients and driving forward quality in joint replacement surgery. Further progress and updates will be available at and the main NJR website at

15 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Part 2: Clinical activity 2013 Now to be found online at Part Two of the NJR 11th Annual Report includes data on clinical activity volumes and surgical technique in relation to procedures carried out between 1 January 2013 and 31 December To be included in the report all procedures must have been entered into the NJR by 28 February On the new, dedicated website, readers will be able to use interactive graphs to identify the key information and trends associated with the following reports for hip, knee, ankle, elbow and shoulder data (where sufficient numbers are available): Total number of hospitals and treatment centres in England, Wales and Northern Ireland able to participate in the NJR and the proportion actually participating Number of participating hospitals, according to number of procedures performed Procedure details, according to type of provider for procedures Patient characteristics for primary replacement procedures, according to procedure type Age and gender for primary replacement patients ASA grades for primary replacement patients Body Mass Index (BMI) for primary replacement patients Indications for primary procedure based on age groups Surgical technique for primary replacement patients Thromboprophylaxis regime for primary replacement patients, prescribed at time of operation Reported untoward intra-operative events for primary replacement patients, according to procedure type Patient characteristics for revision procedures, according to procedure type Indication for surgery for revision procedures Trends in brand use by procedure type, and use of bone cement For hips specifically Components removed during hip revision procedures in 2013 Components used during single-stage hip revision procedures in 2013 Trends in femoral head size and hip articulation For knees specifically Implant constraint for primary procedures Bearing type for primary procedures 15

16 Additional information on the NJR Reports website The following information is available on the dedicated NJR Reports website: NJR 11th Annual Report Part One: Annual progress 2013/14 Part Two: Clinical activity 2013 via interactive reports Part Three: Outcomes following joint replacement surgery 2003 to 2013 Part Four: Trust- Local Health Board- and unit-level activity and outcomes 2013 NJR 11th Annual Report Part One: Annual progress 2013/14 Welsh NJR 11th Annual Report Online appendices comprising: Appendix 1: Steering Committee Membership and Declarations of interest April 2013 to March 2014 Appendix 2: NJR Steering Committee and Sub-committee composition and attendance April 2013 to March 2014 Appendix 3: NJR Steering Committee Terms of Reference Appendix 4: List of papers, publications, and research requests using NJR data April 2013 to March 2014 NJR 11th Annual Report Prostheses used in hip, knee, ankle, elbow and shoulder procedures 2013 NJR 11th Annual Report Public and Patient Guide 16

17 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Part 3: Outcomes after joint replacement 2003 to 2013 Part Three of the NJR 11th Annual Report provides information regarding the survivorship of implants as well as mortality in relation to hip and knee replacement operations carried out in England, Wales and Northern Ireland between 1 April 2003 and 31 December This is the first time the NJR has reported survivorship information in excess of ten years. Short term information is provided for ankle replacements and early data for shoulder replacements is currently being investigated and will be published separately online in the Autumn. Elbow data will be reviewed when numbers are sufficient for meaningful analysis. For the purposes of this analysis in excess of 1.6m records were available but a number of records were excluded. The final analysis comprises 620,400 primary hip replacements, 676,082 primary knee replacement and 2,004 ankle replacements. Hip replacement procedures The 620,400 primary hip replacements were carried out by a total of 2,906 consultants within 460 hospitals. The predominant diagnosis was osteoarthritis in 93%, 40.3% were males and the median age was 69 years (IQR 61-76). The maximum follow-up of these patients was years. The data is presented in terms of fixation and bearing with further analysis to take age and gender into consideration and finally the survivorship of common brands that were used. In 2003 cemented hip replacement was used in 60.5% of cases but this reduced year on year to 31.9% in 2009, then increased slightly to 33.2% in Over the same time period there was a corresponding increase in the use of uncemented implants from 16.8% in 2003 to 42.5% in Over the same period, hybrid hip replacement increased from 12.3% to 20.2% and resurfacing reached a peak of 10.8% in 2006 but then declined to just 1.1% in There were important differences in the choice of bearing surface and mode of fixation. For example, with cemented hip replacement, a metal-onpolyethylene bearing was used in 88.2% of cases whereas when the replacement was uncemented there was greater diversity of bearing selection: metalon-polyethylene was used in 37.1%, ceramic-onceramic in 33.8%, ceramic-on-polyethylene in 14.4% and a metal-on-metal articulation in 11.9%. There was a dramatic rise and then fall in the use of a metal-on-metal bearing with an uncemented construct. For example in 2003, metal-on-metal bearings were used in 7.5% of cases and this peaked in 2007 to 31.1% and then fell away rapidly from 2009 onwards when the adverse effects of metal-on-metal bearings became clear. In 2013 their use had fallen to just 0.1% of cases. In relation to implant survivorship, cemented fixation without adjustment by bearing, age and gender appeared to be the most successful when there was a 3.20% (95% confidence interval ) cumulative percentage probability of revision at 10 years. This compared to 7.68% ( ) with an uncemented, hybrid 3.95% ( ), reverse hybrid 4.77% ( ) and resurfacing 13.01% ( ). However, as mentioned previously, the metal-onmetal articulation was used much more frequently with uncemented fixation and if one compares the most successful bearing combination ceramic-onpolyethylene, the differences in fixation become less marked. For example, when cement was used the tenyear revision probability with ceramic-on-polyethylene was 2.09% compared to 3.73% with uncemented ceramic-on-polyethylene, 2.19% with hybrid ceramicon-polyethylene. These figures were not adjusted for age and gender. A wider range of revision probability was seen when hip replacements were broken down by fixation, 17

18 bearing, age and gender. The data demonstrated low revision rates with ceramic-on-polyethylene bearings and high revision rates with young patients (less than 55 years at the time of surgery). For example, for male patients with all fixation groups and all bearings, the ten-year revision probability was 9.12% in patients less than 55 years compared to 3.45% in patients greater than 75 years. When cemented fixation and a ceramic-on-polyethylene bearing was used in patients less than 55 years, in male patients the ten-year revision estimate was lower at 3.68% and in male patients over 75, was 1.49%. When uncemented fixation and a metal-on-metal bearing was used in male patients less than 55 years, the revision estimate was at 21.82% and females of the same age group 28.39%. In terms of brand analysis, considering the combination of stem and cup, it could be seen that many combinations had a relatively low revision probability at ten years. For example, the ten-year revision probability in all patients when a cemented Charnley stem was used with a cemented Charnley cup was 2.87% ( ) and when an Exeter V40 was used with a Contemporary socket the revision risk at ten years was 3.15% ( ). It was interesting to note that one of the lowest revision risks was that of an Exeter V40 with an Elite Plus cemented cup with a rate of just 1.36%. This represents a construct where the stem is made by one manufacturer and the socket another, a so-called mix and match system. In relation to resurfacing, it could be seen that different brands had different revision probabilities at ten years. The revision probability of the ASR was 30.36% ( ) compared to the BHR of 9.04% ( ). As reported last year the importance of the choice of bearing material could be seen within one particular brand combination, the Corail stem and Pinnacle socket, both made by the same manufacturer. At seven years when a metal-on-metal articulation was used with this construct the revision risk was 8.82% compared to just 1.84% when the ceramic-onpolyethylene bearing was used. The different causes for revision were explored in more detail which identified some intuitive trends; namely a decreasing risk of dislocation with a PTIR of 2.33 per 1000 patient-years in the first year, reducing to 0.66 between years one and three. In comparison the PTIR for adverse reaction to particulate debris was 7.2 with an uncemented metal-on-metal articulation compared to just 0.14 with ceramic-on-polyethylene. The overall PTIR of adverse reaction to particulate debris was 0.10 within the first year increasing to 3.27 between years five and seven. The effect of short-term mortality after hip replacement was studied in detail and published in The Lancet in November The 90-day mortality halved from 0.56% to 0.29% over the eight year period examined. A multivariable analysis failed to demonstrate any significant effect of the type of replacement on short term mortality. Variables that were associated with decreased mortality were spinal anaesthetic, posterior approach, the use of mechanical thromboprophylaxis and the use of chemical thromboprophylaxis. Knee replacement procedures The 676,082 primary knee replacements were carried out by a total of 2,813 surgeons within 450 hospitals. The diagnosis was osteoarthritis in 96% of cases, 57% of patients were female and the median age for primary surgery was 70 years. The follow-up period for these patients extended to years. The joints replaced and patients were analysed according to the type of replacement (total, unicondylar etc), fixation method, constraint and then by brand. In comparison to hip replacement procedures there has been less variation in practice over the last ten years. In 2003, 81.5% of procedures were total knee replacements using a cemented method of fixation and this increased to 88% by Over the same time period, uncemented replacements fell from 6.7% to 2.4% and the use of hybrid fixation from 2.8% to 0.4% of all primary surgeries. In spite of the observation of higher revision rates amongst partial knee replacements (unicondylar and patello-femoral) the proportional use of these has remained at about 8% for unicondylar and 1% for patella-femoral replacement. 18

19 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report The most common type of implant and method of fixation used was a cemented, unconstrained (post cruciate retaining) fixed bearing type total knee replacement which increased in use from 66% in 2003 to 71% in Where a unicondylar knee was implanted there was a trend away from the use of a mobile bearing; from 81.3% of all unicondylar replacements in 2003 to 60% in The ten-year risk of revision for all knee types surviving to that point in time was 4.47% ( ). For cemented, unconstrained fixed bearing total knee replacement the ten-year revision risk was 3.06% ( ), for cemented unconstrained mobile 4.26% ( ), cemented posterior stabilised fixed 3.63% ( ) and cemented posterior stabilised mobile bearing 4.74% ( (fewer than 250 cases remain at risk at the time shown)). Generally the risk of revision is low at ten years (less than 5%) with relatively small differences between the types of bearing, although some fixation/constraint methods do fare better than others (e.g. amongst cemented implants, unconstrained implants have significantly lower risk of revision after ten years). Of those unicondylar implants surviving for ten years, the chance of revision was nearly three times higher than the equivalent group of total knee replacements surviving with little difference between fixed and mobile varieties (11.78% for fixed unicondylar and 12.95% for mobile unicondylar). The age of the patient at time of primary surgery had a profound effect on the revision risk. For example, for female patients aged less than 55 years, the ten year revision risk was 11.07% ( ) compared to 2.0% ( ) for female patients aged 75 or more. When a cemented, unconstrained fixed bearing knee was used the comparable revision risks were 6.79% in female patients under 55 years compared to 1.58% in patients over 75 years. When a unicondylar knee was used in a female, the corresponding risk of first revision for those implants surviving up to ten years was 18.98% and 9.69%. For total knee replacement, analysis by brand revealed similar findings to total hip replacement in that many different brands demonstrated revision risk at ten years, for those surviving to ten years, between 3% and 4% with overlapping confidence intervals indicating similar performances in terms of risk of implant revision. There were some exceptions to this trend for total knee implant brands, notably the Rotaglide + mobile knee had a ten-year revision risk of 7.14% compared with, for example, the PFC which had a risk of implant revision for those surviving to ten years of 2.66%. For unicondylar knees, the risk of implant revision tends to be higher than total knee brands in general and more variable. Amongst unicondylar implant brands with ten years follow-up, the ten-year risk of revision was highest for a Preservation implant at 20.14% compared to an Oxford partial knee implant with a 12.42% chance of being revised after ten years. The risk of revision of different brand types at varying time points after primary surgery are presented in further detail according to surgical method of fixation and constraint choice opted for. The different causes for revision were studied as well as the temporal changes in revision risk by reason for revision. As expected, revision for infection was more common in the first year of surgery and then fell in subsequent years but the opposite was true for pain. Not all types of replacement had a similar risk of revision by reason. For example, when the reason for revision was infection, the PTIR for cemented knees was 1.13 revisions per 1,000 patient-years ( ) compared to 0.7 ( ) for a unicondylar type of replacement. However, for pain, the corresponding rates were higher for unicondylar knees at 3.84 ( ) compared to 0.76 ( ) for cemented total knee replacements. The effect of short-term mortality after knee replacement was studied in detail and published online in The Lancet in July The 45-day mortality almost halved from 0.37% in 2003 to 0.20% over the eight year period examined. A multivariable analysis confirmed mortality rates for unicondylar knee were lower than total knees, which is perhaps to be expected as the former is a less invasive procedure. This advantage, however, would need to be weighed up with the higher rates of revision that are consistently reported for unicondylar than for total knee replacement. 19

20 Ankle replacement procedures A total of 2,004 primary ankle replacements were recorded on the NJR between April 2010 and December These were carried out by a total of 184 surgeons in 196 hospitals. The median age of the patients was 68 years (IQR 61-74) and 57% were male. The Mobility was the most commonly used brand of replacement which decreased in market share from 62.0% in 2010 to 35.6% in The Zenith increased its share from 19.0% to 24.6% over the same period. Nearly all replacements were uncemented. There were 29 revisions recorded which may well be a significant under-reporting. At three years the revision risk was 2.78% ( ) although these early estimates should be viewed with caution. A note on Patient Reported Outcome Measures (PROMs) Last year, the NJR reported PROMs for the first time. This year, no data from the NHS England PROMs programme was available to the NJR from the NHS Health and Social Care Information Centre. 20

21 National Joint Registry for England, Wales and Northern Ireland 11th Annual Report Part 4: Trust-, Local Health Board- and unit-level activity and outcomes 2013 Part Four of the annual report gives performance and data entry quality indicators for Trusts, Local Health Boards (many of whom comprise more than one hospital) and private providers in England, Wales and Northern Ireland for the 2013 calendar year. Outcomes analysis after hip and knee replacement surgery is also provided for the period 2003 to Clinical activity Overall in 2013, 154 NHS Trusts and Local Health Boards (comprising 234 separate hospitals) and 175 independent hospitals reported patients to the NJR. The proportion of joint replacements entered into the NJR against those carried out (compliance) is only available by NHS Trust and Local Health Board. No data on this is currently available from private providers. 77% of NHS providers reported 95% or more of the joint replacements they undertook 16% of NHS providers reported between 80% and 95% and 7% of NHS providers reported less than 80% Note: these figures exclude units in Northern Ireland as compliance is not available. The proportion of patients who gave consent for their details to be entered into the NJR (consent) was available for all hospitals: NHS hospitals 49% of NHS hospitals achieved a consent rate of greater than 95% 31% achieved a consent rate of 80% to 95% and 20% recorded a consent rate of less than 80% Independent hospitals 73% of independent hospitals achieved a consent rate greater than 95% 17% achieved a consent rate of 80% to 95% and 10% recorded a consent rate of less than 80% Similarly, the proportion of entries in which there is significant data to enable the patient to be linked to an NHS number (linkability) was available for all hospitals: NHS hospitals 83% achieved a proportion of patients with a linkable NHS number greater than 95% 12% achieved a proportion of 80% to 95% and 5% recorded a proportion of linkable records of less than 80% Independent hospitals 51% achieved a proportion of patients with a linkable NHS number greater than 95% 39% achieved a proportion of 80% to 95% and 10% recorded a proportion of linkable records of less than 80% Independent hospitals might be expected to have lower linkability rates than NHS hospitals, as a proportion of their patients may come from abroad and not have an NHS number. Outlier units for 90-day mortality or revision rates for the period 2003 to 2013 The observed numbers of revisions of hip and knee replacements for each hospital were compared to the numbers expected given the unit s case-mix in respect of age, gender and reason for primary. Hospitals with a much higher than expected revision rate for hip and knee replacement have been identified (and can be found listed over the page). These hospitals had a revision rate that was outside the 99.8% (3 standard deviation) limit. In other words, there was a 0.2% (one chance in 500) that this result occurred by chance. A total of 20 hospitals reported higher than expected rates of revision for knee replacement and 34 hospitals had higher than expected rates of revision for hip surgery. 21