Abstract
BackgroundIn treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic.MethodsA double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years.DiscussionResults will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded.PROMsOKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT.Trial registrationClinicalTrials.gov ID: NCT03396640.Initial Release: 09/19/2017.Date of enrolment of first participant: 10/11/17.
Highlights
In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty, or a total knee prosthesis (TKA)
It is known that trauma, overload, other disorders and genetic reasons all play a role in osteoarthritis (OA)
Murray et al explain this as a selection bias due to unicompartmental knee arthroplasty (UKA) tending to be implanted in younger, fitter and more active patients than total knee arthroplasty (TKA), while younger, fitter and more active patients tend to have higher revisions rates
Summary
The study has been designed as a superiority type, prospective, double-blinded, parallel-group, multicentre randomized clinical trial (RCT). The UKA group and during surgery shows to have widespread arthritis in the knee, the patient will receive a TKA, but will remain in the study and remain blinded for 1 year. The development of variables over time, e.g. Oxford Knee Score, will be analysed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. Non-knee related complications include DVT with following thromboembolism, anaesthesiology complication, and death Out of these complications, the study group defined Death, Infection, and lack of improvement in OKS at 6 months compared to pre-operatively as an SAE. Based on a patient acceptance ratio of 50% and the current number of partial knees performed in the participating centres, inclusion is expected to last between one and two years as a conservative estimate. It has been amended once, latest on the 18/03/2018
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