Abstract
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, 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 2 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 4 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.
| Original language | English |
|---|---|
| Pages (from-to) | e106740 |
| Journal | BMJ Open |
| Volume | 15 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 12 Dec 2025 |
Keywords
- Aged
- Female
- Humans
- Male
- Middle Aged
- Arthroplasty, Replacement, Shoulder/methods
- Cost-Benefit Analysis
- Multicenter Studies as Topic
- Osteoarthritis/surgery
- Quality of Life
- Rotator Cuff/surgery
- Shoulder Joint/surgery
- Treatment Outcome
- United Kingdom
- Pragmatic Clinical Trials as Topic
- Equivalence Trials as Topic
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(MCHP) : Manchester Centre for Health Psychology
Peters, S. (PI), Ulph, F. (PI), Arden Armitage, C. (Researcher), Borrelli, B. (Researcher), Bowen, A. (Researcher), Byrne-Davis, L. (Researcher), Edge, D. (Researcher), French, D. (Researcher), Hart, J. (Researcher), Todd, C. (Researcher), Skevington, S. (Researcher), Wearden, A. (Researcher), Cotterill, S. (Researcher), Brooks, J. (Researcher), Brown, L. (Researcher), Bull, E. (Researcher), Cordingley, L. (Researcher), Epton, T. (Researcher), Smith, D. (Researcher), Speer, S. (Researcher), Powell, R. (Researcher), Bartlett, K. (Researcher), Coupe, N. (Researcher), Shepherd, S. (Researcher), Dienes, K. (Researcher), Ghio, D. (Researcher), Hood, A. (Researcher), Lavallee, J. (Researcher), Rowland, C. (Researcher), Benton, J. (Researcher), Goldthorpe, J. (Researcher), McWilliams, L. (Researcher), Keyworth, C. (Researcher), Goulding, R. (Researcher), Loughran, M. (Researcher), Hawkes, R. (Researcher), Kapadi, A. (Researcher), Hurley, R. (Researcher), Leather, J. (Researcher), Musa, C. (Researcher), Angelakis, I. (Researcher), Reid, C. (Researcher), Reid, H. (PGR student), Hulme, L. (PGR student), Hindmarch, S. (PGR student), Plant, S. (Researcher), Peterson, J. (Researcher), Woof, V. (PGR student), Devereux-Fitzgerald, A. (Researcher), Sawyer, C. (Researcher), Wilkes, J. (Researcher), Birtwell, K. (Researcher), Stringer, G. (Researcher), Tang, M. Y. (Researcher), Coupe, N. (Researcher), Hamnett, C. (Support team), Lyons, S. (Researcher), Hulme, L. (PGR student) & Lee, R. (Researcher)
1/09/10 → …
Project: Research
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