Introduction: Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function, and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS). Methods and analysis: RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis and an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at two years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants. Ethics and dissemination: Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4th October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets. Trial registration number: ISRCTN12216466 Key words: Osteoarthritis; Total Shoulder Arthroplasty; Randomised controlled trial Strengths and limitations of this study • RAPSODI-UK is a multi-centre, pragmatic, two-arm, parallel, superiority randomised controlled trial with a parallel sister trial being conducted in Australia. • This study includes a full health economic evaluation and a nested qualitative interview study of participants’ experiences. • There will be two-year follow up and beyond using National Joint Registry (NJR) data linkage for longer term follow up. • There is the potential cross-over of randomised participants from anatomic to reverse Total Shoulder Replacement due to a lack of rotator cuff integrity when assessed intra-operatively.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)