Comparative Study

. 2025 Apr 2;26(1):116.

doi: 10.1186/s13063-025-08822-w.

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^{1

2

3}, Richard S Page^{4

5}, Rachelle Buchbinder⁶, Ville Äärimaa⁷, Sam Adie⁸, Graeme Brown⁹, Nancy Cinnadaio^{10

11}, Maurizio Damiani¹², Joseph Descallar¹⁰, Manuela L Ferreira¹³, Nadine E Foster¹⁴, Stephen Gill^{4

5}, Katrina Hutchison¹⁵, Teppo Järvinen¹⁶, Oliver Khoo¹⁷, David Lieu¹⁸, Christopher G Maher¹⁹, Justine M Naylor^{10

11}, Geoff Smith⁸, Luke Spencer²⁰, Yvana Toh¹⁴, Andrew Whan⁵, Tim Yeoh¹⁷

Affiliations

¹ Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia. ianharris@unsw.edu.au.
² School of Clinical Medicine, Faculty of Medicine & Health, UNSW Sydney, PO Box 1274 Darlinghurst, Liverpool, NSW, 1300, Australia. ianharris@unsw.edu.au.
³ Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia. ianharris@unsw.edu.au.
⁴ B-CORE (Barwon Centre for Orthopaedic Research and Education), IMPACT, School of Medicine, Deakin University, Geelong, VIC, Australia.
⁵ St John of God Hospital & Barwon Health, Geelong, VIC, Australia.
⁶ Musculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
⁷ Division of Diseases of the Musculoskeletal System, Turku University Hospital, Turku, Finland.
⁸ School of Clinical Medicine, UNSW Medicine & Health, St George & Sutherland Clinical Campuses, UNSW Sydney, Sydney, NSW, Australia.
⁹ Department of Orthopaedics University Hospital Geelong, Affiliate Senior Lecturer School of Medicine, Deakin University, Geelong, VIC, Australia.
¹⁰ Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia.
¹¹ School of Clinical Medicine, Faculty of Medicine & Health, UNSW Sydney, PO Box 1274 Darlinghurst, Liverpool, NSW, 1300, Australia.
¹² School of Medicine and Psychology, The Australian National University, Canberra, ACT, Australia.
¹³ The George Institute for Global Health, UNSW, Sydney, NSW, Australia.
¹⁴ STARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health, Herston, Brisbane, QLD, Australia.
¹⁵ Department of Philosophy, Macquarie University, Sydney, Australia.
¹⁶ Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
¹⁷ Department of Orthopaedics, St Vincent's Hospital Sydney, Sydney, NSW, Australia.
¹⁸ Orthopaedic Department, Fairfield Hospital, South Western Sydney Local Health District, Sydney, NSW, Australia.
¹⁹ Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.
²⁰ Ballarat Orthopaedics and Sports Medicine, Novar Musculoskeletal Research institute, Grampian Health - Ballarat Base Hospital, Ballarat, VIC, Australia.

PMID: 40176135
PMCID: PMC11963692
DOI: 10.1186/s13063-025-08822-w

Comparative Study

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 et al. Trials. 2025.

. 2025 Apr 2;26(1):116.

doi: 10.1186/s13063-025-08822-w.

Authors

Affiliations

¹ Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia. ianharris@unsw.edu.au.
² School of Clinical Medicine, Faculty of Medicine & Health, UNSW Sydney, PO Box 1274 Darlinghurst, Liverpool, NSW, 1300, Australia. ianharris@unsw.edu.au.
³ Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia. ianharris@unsw.edu.au.
⁴ B-CORE (Barwon Centre for Orthopaedic Research and Education), IMPACT, School of Medicine, Deakin University, Geelong, VIC, Australia.
⁵ St John of God Hospital & Barwon Health, Geelong, VIC, Australia.
⁶ Musculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
⁷ Division of Diseases of the Musculoskeletal System, Turku University Hospital, Turku, Finland.
⁸ School of Clinical Medicine, UNSW Medicine & Health, St George & Sutherland Clinical Campuses, UNSW Sydney, Sydney, NSW, Australia.
⁹ Department of Orthopaedics University Hospital Geelong, Affiliate Senior Lecturer School of Medicine, Deakin University, Geelong, VIC, Australia.
¹⁰ Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia.
¹¹ School of Clinical Medicine, Faculty of Medicine & Health, UNSW Sydney, PO Box 1274 Darlinghurst, Liverpool, NSW, 1300, Australia.
¹² School of Medicine and Psychology, The Australian National University, Canberra, ACT, Australia.
¹³ The George Institute for Global Health, UNSW, Sydney, NSW, Australia.
¹⁴ STARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health, Herston, Brisbane, QLD, Australia.
¹⁵ Department of Philosophy, Macquarie University, Sydney, Australia.
¹⁶ Finnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
¹⁷ Department of Orthopaedics, St Vincent's Hospital Sydney, Sydney, NSW, Australia.
¹⁸ Orthopaedic Department, Fairfield Hospital, South Western Sydney Local Health District, Sydney, NSW, Australia.
¹⁹ Institute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.
²⁰ Ballarat Orthopaedics and Sports Medicine, Novar Musculoskeletal Research institute, Grampian Health - Ballarat Base Hospital, Ballarat, VIC, Australia.

PMID: 40176135
PMCID: PMC11963692
DOI: 10.1186/s13063-025-08822-w

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).

Keywords: Clinical trials; Placebo; Rotator cuff; Shoulder; Surgery.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: The study protocol version 6.0 28 May 2020 was approved by the Human Research Ethics Committees of the South Western Sydney Local Health District on 15 June 2020 (reference number 2020/ETH00754 ) and St John of God Health Care on 18 August 2020 (reference number 1704). Each update to the protocol has been approved by the relevant ethics committee. The study will be performed according to the National Statement on Ethical Conduct in Human Research [49, 50]. As per the National Statement (2018 and 2023, section 3.1.5), placebo controlled trials are ethically acceptable where the current standard of care includes the absence of the intervention being tested and there is no risk of significant harm in the absence of the intervention. All investigators will undergo training in Good Clinical Practice for clinical trials and will complete a study start up site or remote visit that involves training of the site principal investigator and all delegated personnel, on the approved versions of the trial protocol, standard operating procedures and/or relevant essential documents. The protocol and a statistical analysis plan will be published in an open-access journal. The protocol complies with SPIRIT guidelines [51] and the study will be reported according to the CONSORT guidelines [48]. Consent for publication {32}: A model consent form and participant information sheet have been provided as Supplementary Material. Competing interests {28}: The authors declare that they have no competing interests.

References

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1. Yamamoto A, Takagishi K, Osawa T, et al. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg. 2010;19:116–20. - PubMed
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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

Affiliations

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

Authors

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