SAT0724-HPR Technological assisted rehabilitation following total knee joint replacement. a randomised controlled non-inferiority trial

Abstract

Background: Supervised rehabilitation after total knee arthroplasty (TKA) has been suggested effective for quicker recovery. The effect of Technological Assisted Rehabilitation (TAR) in the participant's home compared to supervised rehabilitation has been investigated in trials and results suggest it being equal to supervised rehabilitation on short time follow-up (6 weeks to 4 months). No studies have been found that evaluate the effect of TAR on follow-ups longer than 4 months. Objectives: The aim of this study was to evaluate the effect of TAR compared to supervised rehabilitation (usual care) on participants with TKA after 6 and 12 months. Methods: This was a single-blinded, randomised controlled, non-inferiority study. 155 participants were randomised to either TAR (ICURA) or usual care. Intervention time was 6 weeks, follow-ups were after intervention, at 6 and 12 months. This study only concluded on 6 and 12 months. Primary outcome was 10 m walk test. Secondary outcomes were 2.45 m up and go, 30 s. Sit to Stand, active knee flexion and extension and the KOOS questionnaire. All outcomes were measured at all time points by a blinded assessor. Non-inferiority margin was no statistical significant-and less than 10% between group difference at 6 and 12 months, estimated by a repeated measurement analysis, adjusted for relevant baseline variables. Results: Overall, the groups did not differ at baseline. No statistical between group difference was detected after 6 and 12 months for primary and secondary outcomes. A power analysis suggested severe lack of power to detect a statistical between group difference, due to high numbers of participants lost to follow-up after 6 and 12 months. The between group difference at 6 and 12 months was less than 10% for all outcomes except KOOS Quality of Life at 6 months, were a difference of 12.2% was detected, in favour of ICURA Conclusions: The results show that the effect of ICURA is equal to usual care after 6 and 12 months. Because lack of power after 6 and 12 months, the statistical significance should be interpreted with caution, but overall between group difference after 6 and 12 months was less than 10% for primary and secondary outcomes.