{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Hannah L Rodrick"
    },
    {
      "affiliations": [
        "Department of Trauma and Orthopaedics, University Hospitals of Leicester NHS Trust, Leicester, UK"
      ],
      "name": "Joseph Dias"
    },
    {
      "affiliations": [
        "Musculoskeletal Research Group, Edge Hill University, Ormskirk, UK"
      ],
      "name": "Adam C Watts"
    },
    {
      "affiliations": [
        "Upper Limb Unit, Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK"
      ],
      "name": "Michael J Walton"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Stephen Brealey"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery, Deakin University - Geelong Waterfront Campus, Geelong, Victoria, Australia"
      ],
      "name": "Richard Page"
    },
    {
      "affiliations": [
        "STARS Education and Research Alliance, The University of Queensland and Metro North Health, Brisbane, Queensland, Australia",
        "The School of Health and Rehabilitation Sciences, Faculty of Health, Medicine and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Nadine E Foster"
    },
    {
      "affiliations": [
        "Upper Limb Unit, Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK"
      ],
      "name": "Katy Boland"
    },
    {
      "affiliations": [
        "Department of Research & Development, Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK"
      ],
      "name": "Lindsay J Cunningham"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Caroline Fairhurst"
    },
    {
      "affiliations": [
        "Nottingham Shoulder and Elbow Unit, Nottingham University Hospitals NHS Trust, Nottingham, UK"
      ],
      "name": "John Geoghegan"
    },
    {
      "affiliations": [
        "Patient and Public Involvement (PPI), Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK"
      ],
      "name": "William Greenwood"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Catherine Hewitt"
    },
    {
      "affiliations": [
        "Division of Cancer Sciences, The University of Manchester, Manchester, UK"
      ],
      "name": "Cliona Kirwan"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Heather Leggett"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Catriona McDaid"
    },
    {
      "affiliations": [
        "Centre for Biostatistics, University of Manchester, Manchester, UK"
      ],
      "name": "Matthew Parkes"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Steve Parrott"
    },
    {
      "affiliations": [
        "Division of Psychology and Mental Health, School of Health Sciences, The University of Manchester, Manchester, UK"
      ],
      "name": "Rachael Powell"
    },
    {
      "affiliations": [
        "STARS Education and Research Alliance, The University of Queensland and Metro North Health, Brisbane, Queensland, Australia",
        "The School of Health and Rehabilitation Sciences, Faculty of Health, Medicine and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia"
      ],
      "name": "Jonathan G Quicke"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Gareth Roberts"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Fiona Rose"
    },
    {
      "affiliations": [
        "Department of Trauma and Orthopaedics, University Hospitals of Leicester NHS Trust, Leicester, UK"
      ],
      "name": "Harvinder Pal Singh"
    },
    {
      "affiliations": [
        "Department of Research & Development, Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK"
      ],
      "name": "Helen Spickett"
    },
    {
      "affiliations": [
        "Applied Health Research Unit, University of Lancashire, Preston, UK"
      ],
      "name": "Chris J Sutton"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Fraser Wiggins"
    },
    {
      "affiliations": [
        "Department of Health Sciences, York Trials Unit, University of York, York, UK"
      ],
      "name": "Qi Wu"
    },
    {
      "affiliations": [
        "Upper Limb Unit, Wrightington Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK"
      ],
      "name": "Ian Trail"
    }
  ],
  "title": "Anatomic versus reverse total shoulder replacement for patients with osteoarthritis and intact rotator cuff: the RAPSODI-UK randomised controlled trial protocol",
  "uid": "249f875c-0ac8-56c7-9f42-e3faf7f78060"
}