Physical rehabilitation versus no physical rehabilitation after total hip and knee arthroplasties: Protocol for a pragmatic, randomized, controlled, superiority trial (The DRAW1 trial) [version 2; peer review: 3 approved]

Background: Following total hip- and knee arthroplasty (THA and TKA), post-discharge physical rehabilitation is common practice, but varies significantly regarding content, duration, intensity and mode of delivery. Recent systematic reviews have found home-based rehabilitation to be as good as outpatient rehabilitation in terms of pain and physical function. We therefore wonder if physical rehabilitation “works” at all when compared to no physical rehabilitation after THA and TKA – “no rehabilitation” defined as no prescribed therapeutic rehabilitation exercises. The purpose of this trial is to compare the effectiveness of home-based telerehabilitation, home-based rehabilitation and no physical rehabilitation following THA and TKA. Methods: This pragmatic, randomized controlled trial will include 168 patients following discharge after THA or TKA, in Bornholm Denmark. Patients will be randomized into one of the three 6-week rehabilitation strategies: home-based telerehabilitation, home-based rehabilitation or no physical rehabilitation. The trial is designed as a superiority trial to test the hypothesis that rehabilitation (home-based telerehabilitation and home-based rehabilitation) is superior to no physical rehabilitation. The primary outcome will be the hip disability and osteoarthritis outcome score (HOOS)/ the knee injury and osteoarthritis outcome score (KOOS)-subscale: function of daily living at first follow-up (end of the 6-weeks' intervention). Additional follow-ups are scheduled at 3 and 12 months. Outcome assessors and data analysts are blinded to group allocation. Conclusions: Knowledge about the effectiveness of the three investigated rehabilitation strategies will help guide the future organization of post-discharge rehabilitation after THA and TKA. Trial registration: Clinicaltrials.gov NCT03750448 (23/11/2018