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. 2025 Dec 12;15(12):e106740.
doi: 10.1136/bmjopen-2025-106740.

Anatomic versus reverse total shoulder replacement for patients with osteoarthritis and intact rotator cuff: the RAPSODI-UK randomised controlled trial protocol

Hannah L Rodrick  1 , Joseph Dias  2 , Adam C Watts  3 , Michael J Walton  4 , Stephen Brealey  5 , Richard Page  6 , Nadine E Foster  7   8 , Katy Boland  4 , Lindsay J Cunningham  9 , Caroline Fairhurst  5 , John Geoghegan  10 , William Greenwood  11 , Catherine Hewitt  5 , Cliona Kirwan  12 , Heather Leggett  5 , Catriona McDaid  5 , Matthew Parkes  13 , Steve Parrott  5 , Rachael Powell  14 , Jonathan G Quicke  7   8 , Gareth Roberts  5 , Fiona Rose  5 , Harvinder Pal Singh  2 , Helen Spickett  9 , Chris J Sutton  15 , Fraser Wiggins  5 , Qi Wu  5 , Ian Trail  4
Affiliations

Anatomic versus reverse total shoulder replacement for patients with osteoarthritis and intact rotator cuff: the RAPSODI-UK randomised controlled trial protocol

Hannah L Rodrick et al. BMJ Open. .

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.

Keywords: Orthopaedic & trauma surgery; Orthopedics; Pragmatic Clinical Trial; Randomized Controlled Trial; Shoulder.

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Conflict of interest statement

Competing interests: IT has received grants from Lima, royalties from Stryker and stock from Genesis PLC. AW has reported royalties from Adler Orthopaedics, consulting fees from Medartis and Stryker and has been an honorary secretary of the British Elbow and Shoulder Society (BESS). MW has received fellowship grants from Stryker and Lima, consulting fees, meeting and travel support and payments for lectures from Arthrex. JG has received consulting fees from DePuy European Advisory Group, and lecture payments from Exactech and Arthrex. HS was part of the NIHR grant application for the RAPSODI and DIDACT orthopaedic studies. MP received two institutional grants from the NIHR (NIHR203308 and NIHR205301), payment for being Specialist Examiner for the Royal College of Radiologists and was the independent statistician on the EVEREST-HN, PORTRAIT, POBIG, SWEET and DyNAMIc trials. CH reported being a member of the NIHR HTA Commissioning Committee (2015-2022) and Deputy Chair (2019-2022), an NIHR Senior Investigator, a member of the NIHR HTA General Committee (2023 to present) and Chair (2023 to present), a member of the NIHR CTU SAC (2020-2022) and Co-Director NIHR RSS (2023-present). RiP was part of the NHMRC Grant for RAPSODI-AUSTRALIA (GTN 2008140), provided educational support to De Puy Synthes, Medartis and Stryker, is President of the Shoulder and Elbow Society of Australia and Chair of the Victorian Orthopaedic Foundation. JQ was funded to present RAPSODI-UK qualitative research at the Osteoarthritis Research Society International 2025 held in Incheon, South Korea. Funds were supported by Professor Nadine Foster’s NHMRC Leadership2 Investigator Grant. NF is funded by an Australian National Health and Medical Research Council (NHMRC) Investigator Grant (ID: 2018182). CS is a member of the NIHR HTA Commissioning Committee (January 2020 to present). CMD is a Senior Journal Editor at the NIHR HTA Journal. CK has received a grant from the Royal College of Surgeons of England and Masonic Charitable Foundation Chair in Surgical Trials and is a Trustee of the UK Association of Breast Surgery. SP is part of NIHR grants for the following trials: RESTART-PD, PORTRAIT, SCIMITAR, HAMLET, YORQUIT, ADVANCE-D, SCOOTT, PHIRST, RESPIRE-2, PAMHOP and SCeTCH. RaP reported travel expenses for a PPI contribution meeting (June 2024) as part of the RAPSODI-UK NIHR grant. FR and HR are both employed as trial coordinators on the RAPSODI-UK and DIDACT trials. SB is employed as trial manager on the RAPSODI-UK, DIDACT and ACTIVE trials. All other authors have no competing interest to declare.

Figures

Figure 1
Figure 1. Overview of trial design and flow of participants through the trial.
Figure 2
Figure 2. Diagram of a total shoulder (anatomic) replacement (left) and a reverse shoulder replacement (right).
Figure 3
Figure 3. RAPSODI-UK trial assessment schedule. ROM, range of movement; SPADI, Shoulder Pain and Disability Index. 1Baseline assessments will be prior to randomisation except for baseline Range of Movement and Strength which may be collected, when necessary, after randomisation by an independent blinded assessor. 2This includes radiographs (typically anteroposterior and axial) to confirm osteoarthritis; CT or other imaging to assess glenoid erosion; and CT, MRI or US to assess the rotator cuff. 3Assessment of cuff integrity in theatre before operating and the possible use of fluoroscopy during surgery. 4This includes an assessment of implant problems using post-operative radiographs and radiographs at 24 months or earlier if not available. The radiographs will typically be anteroposterior and axial.
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