Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021). Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings. The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training. We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.
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.
