Evidence map›Paper›PMID 40176135›Full record

ArticleTrials2025

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 and 13 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Ian A HarrisWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia. ianharris@unsw.edu.au.ORCID http://orcid.org/0000-0003-0887-7627
Richard S PageB-CORE (Barwon Centre for Orthopaedic Research and Education), IMPACT, School of Medicine, Deakin University, Geelong, VIC, Australia.
Rachelle BuchbinderMusculoskeletal Health and Wiser Health Care Units, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Ville ÄärimaaDivision of Diseases of the Musculoskeletal System, Turku University Hospital, Turku, Finland.
Sam AdieSchool of Clinical Medicine, UNSW Medicine & Health, St George & Sutherland Clinical Campuses, UNSW Sydney, Sydney, NSW, Australia.
Graeme BrownDepartment of Orthopaedics University Hospital Geelong, Affiliate Senior Lecturer School of Medicine, Deakin University, Geelong, VIC, Australia.
Nancy CinnadaioWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia.
Maurizio DamianiSchool of Medicine and Psychology, The Australian National University, Canberra, ACT, Australia.
Joseph DescallarWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia.
Manuela L FerreiraThe George Institute for Global Health, UNSW, Sydney, NSW, Australia.
Nadine E FosterSTARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health, Herston, Brisbane, QLD, Australia.
Stephen GillB-CORE (Barwon Centre for Orthopaedic Research and Education), IMPACT, School of Medicine, Deakin University, Geelong, VIC, Australia.
Katrina HutchisonDepartment of Philosophy, Macquarie University, Sydney, Australia.
Teppo JärvinenFinnish Centre for Evidence-Based Orthopaedics (FICEBO), University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Oliver KhooDepartment of Orthopaedics, St Vincent's Hospital Sydney, Sydney, NSW, Australia.
David LieuOrthopaedic Department, Fairfield Hospital, South Western Sydney Local Health District, Sydney, NSW, Australia.
Christopher G MaherInstitute for Musculoskeletal Health, School of Public Health, University of Sydney, Sydney, NSW, Australia.
Justine M NaylorWhitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, 1 Campbell Street, Liverpool, NSW, Australia.
Geoff SmithSchool of Clinical Medicine, UNSW Medicine & Health, St George & Sutherland Clinical Campuses, UNSW Sydney, Sydney, NSW, Australia.
Luke SpencerBallarat Orthopaedics and Sports Medicine, Novar Musculoskeletal Research institute, Grampian Health - Ballarat Base Hospital, Ballarat, VIC, Australia.
Yvana TohSTARS Education and Research Alliance, Surgical Treatment and Rehabilitation Service (STARS), The University of Queensland and Metro North Health, Herston, Brisbane, QLD, Australia.
Andrew WhanSt John of God Hospital & Barwon Health, Geelong, VIC, Australia.
Tim YeohDepartment of Orthopaedics, St Vincent's Hospital Sydney, Sydney, NSW, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDegenerative 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.

methodsThe 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 registrationThe 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).

Indexed as

ArthroscopyRotator CuffRotator Cuff InjuriesShoulder PainAdultAgedAustraliaFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPain MeasurementRandomized Controlled Trials as TopicRange of Motion, ArticularRecovery of FunctionClinical trialsPlaceboRotator cuffShoulderSurgery

Identifiers

PMID40176135
PMCPMC11963692

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.