Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT

Abstract

Background: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection.

Objective: To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers.

Design: This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target sample size was 500 patients. A web-based randomisation system was used to allocate treatments.

Setting: Twenty-seven NHS hospitals (68 surgeons).

Participants: Patients with medial compartment knee osteoarthritis.

Interventions: The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated.

Main outcome measures: The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed.

Results: A total of 528 patients were randomised (partial knee replacement, n = 264; total knee replacement, n = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval -0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) (n = 233), mean 35.1 (standard deviation 9.1) (n = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 'failures' of partial knee replacement and 38 'failures' of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use.

Limitations: It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure.

Conclusions: Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years.

Future work: Further (10-year) follow-up is in progress to assess the longer-term stability of these findings.

Trial registration: Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 20. See the NIHR Journals Library website for further project information.

Keywords: ARTHROPLASTY; DECISION-MAKING; EQUIPOISE; EXPERTISE; KNEE REPLACEMENT; OSTEOARTHRITIS; PARTIAL KNEE REPLACEMENT; TOTAL KNEE REPLACEMENT.

Conflict of interest statement

Jonathan A Cook reports grants from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme during the conduct of the study and was a member of the NIHR HTA Efficient Trial Designs Board between 2014 and 2016. He was also a member of the NIHR HTA End of Life Care and Add-on Studies Board during these years and a member of a NIHR Research for Patient Benefit programme regional advisory committee (South Central/South East & Central) between 2015 and 2019. Graeme MacLennan reports grants from the NIHR HTA programme during the conduct of the study. Ray Fitzpatrick reports membership of the HTA Prioritisation Group and the HTA National Stakeholder Advisory Group during the conduct of the study (October 2015 to present). Nigel Arden reports grants from Merck & Co. (Kenilworth, NJ, USA), personal fees from Flexion Therapeutics (Burlington, MA, USA), Freshfields Bruckhaus Deringer (London, UK), Merck & Co., Regeneron Pharmaceuticals (Tarrytown, NY, USA) and Eli Lilly and Company (Indianapolis, IN, USA)/Pfizer Inc. (New York, NY, USA) outside the submitted work. Andrew Price reports personal fees from Zimmer Biomet (Warsaw, IN, USA), DePuy (Warsaw, IN, USA) and Smith & Nephew (Watford, UK); he also reports grants from NIHR and Arthritis Research UK outside the submitted work. David Murray reports grants and personal fees from Zimmer Biomet outside the submitted work; in addition, he has various patents relating to knee replacement with royalties paid. Marion K Campbell reports grants from NIHR during the conduct of the study.