The ODEP (Orthopaedic Data Evaluation Panel) rating system should offer a surgeon and patient extra information when making a choice on which implant to use. However, in the current economic environment, ratings may also influence implant choice by contracting bodies. Our aim was to determine the performance of commonly used Acetabular and femoral components in our unit and compare these to their published ODEP ratings (or absence of rating). We analysed all of the following primary THR components (12,792) for revision for any reason, using same date ranges as ODEP where more than 100 implantations had occurred. Hip components: Trinity (3A in 2013), Trilogy (10A* in 2016), Atlas (10A in 2013), Trilogy TMT (10A 2010) Durom (not rated), BHR (10A, 2010), ACCIS (not rated); Femoral components: Taperfit (10A in 2013), Taperloc (10A* in 2016), Metafix (3A in 2013), CPT (10A in 2012), Ecofit (not Rated), ESOP (not rated), Minihip (3A 2013), Durom (not rated), BHR (10A 2010), ACCIS (not rated). Analysis of Kaplan Meier survival curves was undertaken for all components. The rated components and non-rated components were compared using HR and logrank tests for all time groups when ratings were introduced. No statistical difference was observed in any group except for the Trinity cup which had a 98.2% (1344 cups) survival at 6 years. Component survival in our unit was better than ODEP suggested failure for A category of not more than 1% per year, for all components. Whilst we applaud the intention to improve data available for prostheses, the present ODEP system does not distinguish between performances of different implants in our unit. We therefore recommend care when relying upon ODEP ratings to make clinical or contracting decisions

Abstract

Aims. To review the evidence and reach consensus on recommendations for follow-up after total hip and knee arthroplasty. Methods. A programme of work was conducted, including: a systematic review of the clinical and cost-effectiveness literature; analysis of routine national datasets to identify pre-, peri-, and postoperative predictors of mid-to-late term revision; prospective data analyses from 560 patients to understand how patients present for revision surgery; qualitative interviews with NHS managers and orthopaedic surgeons; and health economic modelling. Finally, a consensus meeting considered all the work and agreed the final recommendations and research areas. Results. The UK poSt Arthroplasty Follow-up rEcommendations (UK SAFE) recommendations apply to post-primary hip and knee arthroplasty follow-up. The ten-year time point is based on a lack of robust evidence beyond ten years. The term 'complex cases' refers to individual patient and surgical factors that may increase the risk for arthroplasty failure. For Orthopaedic Data Evaluation Panel (ODEP) 10A* minimum implants, it is safe to disinvest in routine follow-up from one to ten years post-non-complex hip and knee arthroplasty provided there is rapid access to orthopaedic review. For ODEP 10A* minimum implants in complex cases, or non-ODEP 10A* minimum implants, periodic follow-up post-hip and knee arthroplasty may be required from one to ten years. At ten years post-hip and knee arthroplasty, clinical and radiological evaluation is recommended. After ten years post-hip and knee arthroplasty, frequency of further follow-up should be based on the ten-year assessment; ongoing rapid access to orthopaedic review is still required. Conclusion. Complex cases, implants not meeting the ODEP 10A* criteria, and follow-up after revision surgery are not covered by this recommendation. Cite this article: Bone Jt Open 2023;4(2):72–78

Aim of this work is to critically analyze the current mandatory trend to adapt femoral cementless implant shape as to allow their use through mini-invasive anterior hip approach (MIS-AA). During decades, designers of cementless stems tried to adapt implant shapes to patient anatomy, that led to various classification systems (straight, curved, anatomic, etc …). Another way to classify cementless stems is according to their longevity, outcome quality and long-term results. This is the goal of the Orthopaedic Data Evaluation Panel (ODEP) that provided in 2017 an approved list of prostheses that meet at least the NICE 10y revision rate standard. In the last available ODEP 2020 issue, the best rating (13y experience “13”, with strong evidence “A” and < 6.5% rev rate “∗”) was achieved by only 10 cementless implant: Mallory-Head®, Taperloc®, Bimetric®, Accolade®, SL-Alloclassic®, Corail®, CLS Spotorno®, Furlong®, Synergy® & Versys Fibermetal®. All 10 are Ti straight tapers with large metaphyseal morphology in particular in Gruen Zone I. All these 10 ODEP 13A∗ cementless stems can universally be implanted through postero-lateral (PL), MIS-PL, lateral & conventional anterior approaches, but not safely through MIS-AA. Conversely, only new short and curved stems can be inserted safely through MIS-AA. Indeed, surgeons who promote MIS-AA cannot routinely use those successful femoral implants classified ODEP 13A∗. Obviously, surgical approach determines the choice of femoral component. Surgeons who promote MIAA can only bet/hope that these new short curved implants with currently very few clinical evidence will reach the same success and longevity that ODEP 13A∗ conventional straight tapers. Only future long-term studies will address that concern

Introduction. THR is one of the most frequently performed operations nationally. A large number of prostheses are available, and the procedure is therefore associated with variation in practice and outcomes. NICE guidelines aim to standardise best practice, and are informed by separate, independent bodies, such as the NJR and ODEP, which monitor data about the implants used and their performance. This study aims to determine whether clinical practice and component use has changed since the publication of NJR data. Methods. NJR reports from 2006–2014 were analysed, with record made of the different prostheses used in THR, noting ODEP ratings of components used. Analysis was also performed by component type (i.e. cemented and cementless stems and cups), and combinations of components, according to their frequency of use in a given year. The Kruksal-Wallis test was used for statistical analysis. Results. Analysis revealed that the number of components used with an A ODEP rating has increased from 2006–2014. However, there was no significant change (p=0.37) in the use of these components when expressed as a percentage of total procedures performed. Use of ODEP B, C and unclassified prostheses does not appear to have declined. During the period of study there has been a 9% rise in the number of implant combinations used, and a 37.9% rise in the number of implant combinations used fewer than 10 times annually, though these procedures now account for a lower percentage of the total performed annually. Discussion. Our analysis demonstrates that there has been limited change in practice since the publication of NJR data. A large variety of implants and products persist without evidence of long-term success. Furthermore, many components are used infrequently, raising concerns that surgeons may be less familiar with their nuances. There is a significant risk of higher costs due to increased primary expenditure and complications leading to avoidable, early revision. Conclusion. We conclude that NJR data publication does not directly influence clinical practice

Background. Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. Design. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset. Discussion. Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimum treatment will improve patient outcomes and have important health economic implications. Cite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation – WH. I. TE 3: HEMI – An Abridged Protocol. Bone Joint Res 2016;5:18–25. doi: 10.1302/2046-3758.51.2000473

Follow-up of arthroplasty varies widely across the UK. The aim of this NIHR-funded study was to employ a mixed-methods approach to examine the requirements for arthroplasty follow-up and produce evidence-based and consensus-based recommendations. It has been supported by BHS, BASK, BOA, ODEP and NJR. Four interconnected work packages have recently been completed: (1) a systematic literature review; (2a) analysis of routinely collected National Health Service data from four national data sets to understand when and which patients present for revision surgery; (2b) prospective data regarding how patients currently present for revision surgery; (3) economic modelling to simulate long-term costs and quality-adjusted life years associated with different follow-up care models and (4) a Delphi-consensus process, involving all stakeholders, to develop a policy document to guide appropriate follow-up care after primary hip and knee arthroplasty. We will present the following Recommendations:. For ODEP10A∗ minimum implants, it is safe to disinvest in routine follow-up from 1 to 10 years post non-complex hip and knee replacement provided there is rapid access to orthopaedic review. For ODEP10A∗ minimum implants in complex cases, or non-ODEP10A∗ minimum implants, periodic follow-up post hip and knee replacement may be required from 1 to 10 years. At 10 years post hip and knee replacement, we recommend clinical, which may be virtual, and radiographic evaluation. After 10 years post hip and knee replacement, frequency of further follow-up should be based on the 10-year assessment; ongoing rapid access to orthopaedic review is still required. Overarching statements. These recommendations apply to post primary hip and knee replacement follow-up. The 10-year time point in these recommendations is based on a lack of robust evidence beyond ten years. The term complex cases refer to individual patient and surgical factors that may increase the risk for replacement failure

Over 800 total hip replacement (THR) constructs were implanted in the UK in 2017. To ensure reliable implants are used, a NICE revision benchmark of 5% after 10 years exists. Surgeons are guided in choice by organisations such as the Orthopaedic Data Evaluation Panel (ODEP). Currently, ODEP publishes ratings for stem and cup separately and not for constructs. We used NJR data to investigate whether revision estimates of an individual stem (with all cups) is an accurate indicator of survival of all constructs using that stem. The dataset comprised 234,289 THRs using the most frequently implanted stem between 2004 and 2017. Crude ten-year revision estimates were calculated using Kaplan-Meier for all THRs and for the five most implanted constructs. Adjusted comparisons between individual constructs and the overall stem revision estimate were made using flexible parametric survival analysis. The 10-year crude, revision estimate for all THRs was 2.3% (95% CI 2.2, 2.4). Only four of the most frequently used constructs had long enough follow-up to analyse. 10-year estimates for these constructs ranged from 1.8% (95% CI 1.5, 2.1) to 3.7% (95% CI 3.2, 4.1), a log-rank test revealed strong evidence against the null hypothesis that revision estimates were the same for all constructs (p<0.001). Adjusted for age, sex and ASA, three of the four constructs showed a difference in 10-year revision estimates compared to this stem with all cups (P=0.03, P<0.001, P<0.001). This study suggests 10-year revision estimates for all THRs using the most implanted stem in the NJR are not representative of all constructs involving that stem in crude or adjusted analyses. Current benchmarking systems report survival for the stem in combination with all cups and not for constructs. We suggest that benchmarking ratings basing on revision estimates for THR constructs would provide more accurate information, enabling informed construct decisions

Introduction: Measurement of outcome after THR is becoming increasingly important. NICE guidelines have been established and ODEP have stipulated target criteria for the successful evaluation of novel implants. To date, a streamlined, efficient Outcome Programme has not been developed which satisfies the required follow-up criteria. A Programme has been developed at our unit and its evolution is reported. Methods: A database was created with the assistance of a database developer and an “Outcome Co-ordinator” was appointed to operate the database and manage the programme. Operation data is now entered onto the database by the surgeon or co-ordinator at the time of surgery. Thereafter, the database automatically produces annual Oxford Hip Questionnaires, EQ-5D questionnaires and invite letters to patients for clinical review at stipulated time-points. Questionnaires are returned by patients and scanned. This data is then electronically imported to the database without transcription error. Patients attend special Outcome clinics, staffed by Research Fellows and SpR’s, who examine the relevant hip and review their radiographs. The findings are recorded and the paper forms scanned and imported into the database. Non-responders are identified from the database and are chased up via telephone by the coordinator. Data is extracted from the database with queries and presented using database reports. Results: 2455 THR’s have been recorded on the database (2127 primaries, 328 revisions) 1937 patients continue under active review for THR. The percentage of patients lost to follow-up is only 2%, 10%, 15% at 2, 5 and 10 years respectively. Discussion: An efficient system has been developed to maximise the follow-up of patients post THR. The burden on outpatient clinics is reduced and meaningful outcome measures are obtained. The programme could easily be extended to other centres throughout the UK and the benchmarks set by ODEP and NICE can also be attained

Introduction. The alternative kinematic alignment (KA) technique for total knee arthroplasty (TKA) aims at restoring the native joint line orientation and laxity of the knee. The goal is to generate a more physiological prosthetic knee enabling higher functional performance and satisfaction for the patient. KA TKA have only been reported so far with cruciate retaining and posterior-stabilised designs. Similarly, medial pivot design for TKA has been recently developed to enable more natural knee kinematics and antero-posterior stability. The superiority of KA technique and medial pivot implant design is still controversial when compared to current practice. Our study aims to assess the value of KA TKA when performed with medial pivot implants. Methods. We conducted a retrospectively matched case-control study. Clinical data was prospectively collected on patients as part of an ongoing ODEP study. Thirty-three non-selected consecutive KA TKAs performed by the lead author were matched to a control group of 33 measured resection with mechanically aligned (MA) TKAs performed by other consultant surgeons. Patients were matched for sex, age, BMI and pre-operative Oxford Knee Score (OKS). Pre-operative median OKS was 21 points (max 48), mean age was 69, mean BMI 31, and there were 21 female patients in both arms. The medial pivot GMK Sphere implant (Medacta, Switzerland) was used in all cases. OKS and EQ-5D scores were measured pre-operatively and at 1-year post-op. Patient outcome satisfaction scores were assessed at 1-year follow-up using a visual analogic scale (VAS). Pre- and post-operative knee radiographs were analysed using TraumaCad software. Results. No reoperation or revision was recorded in either group. KA patients were found to have higher OKS (median 44 Vs 42, p=0.78), satisfaction (median 99/100 Vs 90/100, p=0.28), and EQ-5D improvement (mean 0.34 Vs 0.28, p=0.21) compared to MA patients; however, none of the differences discovered were statistically significant. In addition, KA patients had a femoral component that was on average, 3.5° more valgus orientated (aLDFA 84° Vs 80°, p<0.05) and 2.1° more flexed (4.4° Vs 2.3°, p=NS), and a tibial component with 3.6° (aMPTA 86° Vs 89.6°, p<0.05) and 3.9° (5.5° Vs 1.6°, p<0.05) increased varus orientation and posterior slope, respectively. Conclusion/Discussion. KA TKA performed with medial pivot implant design has shown good safety and efficacy at early-term. The physiological implantation provided by the KA technique seems to be clinically beneficial compared to MA implantation, although, the measured differences did not show statistical significance. Having a low study power and high ceiling effect of outcome measure tools may partly explain our results. Early results for KA TKA are encouraging and longer follow-up is warranted to assess longevity of results. For any figures or tables, please contact authors directly

INTRODUCTION. Historically, the clinical performance of novel implants was usually reported by designer surgeons who were the first to acquire clinical data. Regional and national registries now provide rapid access to survival data on new implants and drive ODEP ratings. To assess implant performance, clinical and radiological data is required in addition to implant survival. Prospective, multi-surgeon, multi-centre assessments have been advocated as the most meaningful. We report the preliminary results of such a study for the MiniHip™femoral component and Trinity™ acetabular component (Corin Ltd, UK). METHODS. As part of a non-designer, multi-surgeon, multi-centre prospective surveillance study to assess the MiniHip™stem and Trinity™ cup, 535 operations on 490 patients were undertaken. At surgery, the average age and BMI of the study group was 58.2 years (range 21 to 76 years) and 27.9 (range 16.3 to 43.4) respectively. Clinical (Harris Hip Score, HHS) and radiological review have been obtained at 6 months, 3 and 5 years. Postal Oxford Hip Score (OHS) and EuroQol- 5D (EQ5D) score have been obtained at 6 months and annually thereafter. To date, 23 study subjects have withdrawn or lost contact, 11 have died, and 9 have undergone revision surgery. By the end of March 2018, 6 month, 1, 2, 3, 4, and 5 year data had been obtained for 511, 445, 427, 376, 296 and 198 subjects respectively. RESULTS. Implant revision rate is 1.68% (9/535), with revision for any reason as an endpoint; four of the nine involved the revision of the femoral component. At the 5-year time point, mean OHS had improved from 21.3 to 42.5 (p<0.01), EQ5D from 0.42 to 0.82 (p<0.01), and HHS from 51.6 to 92.5 (p<0.01). Radiological analysis is ongoing, and thus far has revealed more variation in stem alignment than is usually observed for more conventional length femoral components. This may indicate that optimal alignment of calcar loading short stems is different to that of longer, medullary canal aligned implants, consistent with the neck-stabilised design of the MiniHip™ stem. No other significant radiological findings were noted. During surgery, 31 calcar fractures were sustained, of which 20 were treated with cerclage wiring, 1 with femoral grafting and the remainder required no treatment. None of the hips with calcar fractures have been revised to date. DISCUSSION. The clinical and radiological performance of the MiniHip™ femoral stem is consistent with established femoral implants. Longer surveillance will determine whether this performance is maintained. Patients in this study will be continued to be followed-up and reviewed at the 7 and 10-year time points. CONCLUSION. The MiniHip™ stem is safe and efficacious at mid-term follow-up

Aims

Despite multiple trials and case series on hip hemiarthroplasty designs, guidance is still lacking on which implant to use. One particularly deficient area is long-term outcomes. We present over 1,000 consecutive cemented Thompson’s hemiarthroplasties over a ten-year period, recording all accessible patient and implant outcomes.

Introduction. The need for the stringent surveillance of new devices was recognised by the NICE review of hip replacement surgery in 2000 and led to the Orthopaedic Data Evaluation Panel (ODEP) developing criteria for post-marketing surveillance (PMS) studies. This requirement has been reinforced by the recent recall of ASR devices. Methods. The South West London Elective Orthopaedic Centre's (EOC's) comprehensive outcomes programme has been adapted to manage and coordinate multi-centre, multi-surgeon, PMS studies. The system allows any schedule and combination of patient-reported outcome measures (PROMS), clinical and radiological assessments, and complications to be collected. Typically, PROMS are collected pre-operatively and yearly by post. Baseline clinical assessment is undertaken pre-operatively, with baseline radiological assessments pre- and post-operatively. Subsequent clinical and radiological assessments are usually obtained at the ODEP-mandated time points of 3, 5, 7 and 10 years post-operatively. Patients are telephoned twice yearly to document complications and any impending change of address. Results. EOC co-ordinated studies extend the ODEP criteria to provide high quality evidence on implant survivorship and patient outcome. In one study, over 500 subjects are under review. The operations were undertaken by twelve surgeons, at three centres. At 3 years participant withdrawal is 4%, mortality 4%, loss to follow-up 1% and revisions 0.5%. Average annual return of PROMS is 94%, and the percentage of invited patients returning for a 3 year review is 81%. Discussion. The EOC system provides a cost-effective method for the long-term follow-up of implants through multi-site, multi-surgeon national, and international, PMS studies. Participation by high-volume centres facilitates both rapid recruitment of study participants and the infrastructure required to maintain consistent data quality. The acquired information gives timely information to surgeons, manufacturers and healthcare purchasers. We advocate adoption of the EOC PMS model for all new implants that are introduced to the UK market

Aims

The primary aim of this study is to assess the survival of the uncemented hydroxyapatite (HA) coated Trident II acetabular component as part of a hybrid total hip arthroplasty (THA) using a cemented Exeter stem. The secondary aims are to assess the complications, joint-specific function, health-related quality of life, and radiological signs of loosening of the acetabular component.

Aims

Total knee arthroplasty (TKA) is a common and safe orthopaedic procedure. Zimmer Biomet's NexGen is the second most popular brand of implant used in the UK. The primary cause of revision after the first year is aseptic loosening. We present our experience of using this implant, with significant concerns around its performance with regards early aseptic loosening of the tibial component.

Aims

“Get It Right First Time” (GIRFT) and NHS England’s Best Practice Tariff (BPT) have published directives advising that patients over the ages of 65 (GIRFT) and 69 years (BPT) receiving total hip arthroplasty (THA) should receive cemented implants and have brought in financial penalties if this policy is not observed. Despite this, worldwide, uncemented component use has increased, a situation described as a ‘paradox’. GIRFT and BPT do, however, acknowledge more data are required to support this edict with current policies based on the National Joint Registry survivorship and implant costs.

Aims

This study aimed to compare the change in health-related quality of life of patients receiving a traditional cemented monoblock Thompson hemiarthroplasty compared with a modern cemented modular polished-taper stemmed hemiarthroplasty for displaced intracapsular hip fractures.

Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67 045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%).

Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data.

Cite this article: Bone Joint J 2015;97-B:10–18.

Objectives

High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA).