ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for people with shoulder pain and non-acute rotator cuff tears
Ian A. Harris,
Richard S. Page,
Rachelle Buchbinder,
Ville Äärimaa,
Sam Adie,
Graeme Brown,
Nancy Cinnadaio,
Maurizio Damiani,
Joseph Descallar,
Manuela L. Ferreira,
Nadine E. Foster,
Stephen Gill,
Katrina Hutchison,
Teppo Järvinen,
Oliver Khoo,
David Lieu,
Christopher G. Maher,
Justine M. Naylor,
Geoff Smith,
Luke Spencer,
Yvana Toh,
Andrew Whan,
Tim Yeoh
Affiliations
Ian A. Harris
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Richard S. Page
B-CORE (Barwon Centre for Orthopaedic Research and Education), IMPACT, School of Medicine, Deakin University
Rachelle Buchbinder
Musculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University
Ville Äärimaa
Division of Diseases of the Musculoskeletal System, Turku University Hospital
Sam Adie
School of Clinical Medicine, UNSW Medicine & Health, St George & Sutherland Clinical Campuses, UNSW Sydney
Graeme Brown
Department of Orthopaedics University Hospital Geelong, Affiliate Senior Lecturer School of Medicine, Deakin University
Nancy Cinnadaio
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Maurizio Damiani
School of Medicine and Psychology, The Australian National University
Joseph Descallar
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Manuela L. Ferreira
The George Institute for Global Health, UNSW
Nadine E. Foster
STARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health
Stephen Gill
B-CORE (Barwon Centre for Orthopaedic Research and Education), IMPACT, School of Medicine, Deakin University
Katrina Hutchison
Department of Philosophy, Macquarie University
Teppo Järvinen
Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki and Helsinki University Hospital
Oliver Khoo
Department of Orthopaedics, St Vincent’s Hospital Sydney
David Lieu
Orthopaedic Department, Fairfield Hospital, South Western Sydney Local Health District
Christopher G. Maher
Institute for Musculoskeletal Health, School of Public Health, University of Sydney
Justine M. Naylor
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research
Geoff Smith
School of Clinical Medicine, UNSW Medicine & Health, St George & Sutherland Clinical Campuses, UNSW Sydney
Luke Spencer
Ballarat Orthopaedics and Sports Medicine, Novar Musculoskeletal Research institute, Grampian Health - Ballarat Base Hospital
Yvana Toh
STARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health
Andrew Whan
St John of God Hospital & Barwon Health
Tim Yeoh
Department of Orthopaedics, St Vincent’s Hospital Sydney
Abstract Background Degenerative rotator cuff tears are common and are often treated with surgical repair. Randomised trials have not shown a clear advantage to surgery over non-surgical treatment, but there have been no published placebo-controlled trials investigating rotator cuff repair. This study aims to compare arthroscopic shoulder surgery with rotator cuff repair to surgery without rotator cuff repair (placebo) for improving shoulder pain and function in people with shoulder pain and full-thickness degenerative rotator cuff tears. Methods The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). Participants will be people aged 40–75 years (inclusive) with more than 6 months of shoulder pain, a degenerative (non-traumatic) full thickness rotator cuff tear 1 to 4 cm in length for whom surgery is recommended and repair of the tear is the main reason for surgery. The intervention is arthroscopic surgery (including—as indicated—bursectomy, debridement, acromioclavicular joint resection, acromioplasty and biceps tenodesis or tenotomy) with rotator cuff repair. The control is the same arthroscopic shoulder surgery without rotator cuff repair. Participants will be randomised to cuff repair or no cuff repair in a 1:1 ratio intra-operatively, after all other surgical procedures have been performed. Participants, follow-up surgeons, physiotherapists, study staff and statisticians will be blinded. Post-surgical rehabilitation will be usual care for rotator cuff repair in both groups. The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery. Discussion The ARC trial will provide low bias evidence on a common surgical procedure: rotator cuff repair for degenerative tears. Trial registration The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12620000789965) on 5 August 2020 and the WHO International Clinical Trials Registry Platform (universal trial number U1111-1251-6599).
