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Trial registered on ANZCTR

Registration number

ACTRN12620000789965

Ethics application status

Approved

Date submitted

12/06/2020

Date registered

5/08/2020

Date last updated

10/06/2025

Date data sharing statement initially provided

5/08/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

A combined randomised and observational study of surgical repair of rotator cuff tears in adults

Scientific title

The ARC (Australian Rotator Cuff) Trial: 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

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1251-6599

Trial acronym

The ARC trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rotator Cuff tear

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arthroscopic shoulder surgery with rotator cuff repair. The arthroscopic surgery will be performed in operating theatres of the participating institutions by registered orthopaedic surgeons. Participant randomisation to the intervention will occur intra-operatively. Prior to randomisation, concomitant procedures such as bursal debridement, acromioplasty, AC joint resection and biceps tendon tenodesis or tenotomy may be performed, if required. The use of the surgical technique will be as per the surgeon's preference. The arthroscopic surgery with concomitant procedures is likely to take less than 2 hours. Post-operative treatment will be standardised between the intervention and control group. Post-operative analgesia (including nerve blocks) will be as per usual care. Post-operative physiotherapy will be undertaken as an outpatient following discharge. The physiotherapy will follow a standard four phase program, with progression along the phases, dependent on the individual’s time and milestone achievement. Follow up care will occur under a surgeon blinded to the participant’s treatment allocation and will be as per usual care.

Participants who do not want to part take in the surgical intervention will be approached to enroll in an observational cohort where their treatment and outcomes will be followed during the same time period as the randomised controlled trial. No intervention is administered to the observational cohort. Participants will receive their usual care by their treating doctor (eg continued physiotherapy or arthroscopic surgery) as decided by patient preference. Follow up measures will be identical to those specified in the randomised controlled trial with the exception that adverse event reporting and MRI pre and post imaging will not be collected.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

The placebo surgery arm will receive identical treatment to the intervention arm except no repair to the rotator cuff tear will be performed during the surgery. Prior to the participant’s intra-operative randomisation, concomitant procedures such as bursal debridement, acromioplasty, AC joint resection and biceps tendon tenodesis or tenotomy may be performed if required. Post-operative analgesia (including nerve blocks) will be as per usual care. Post-operative physiotherapy will be undertaken as an outpatient following discharge. The physiotherapy will follow a standard four phase program, with progression along the phases, dependent on the individual’s time and milestone achievement. Follow up care will occur under a surgeon blinded to the participant’s treatment allocation and will be as per usual care.

Control group

Placebo

Outcomes

Primary outcome [1]

Western Ontario Rotator Cuff (WORC) index score. The WORC is a quality of life questionnaire specific to rotator cuff tendinopathy. Superiority of rotator cuff repair will require a minimum clinically important difference (MCID) of 0.5SD in the WORC Index, based on a distribution method of determining the MCID.

Timepoint [1]

6 months post surgery.

Secondary outcome [1]

Western Ontario Rotator Cuff (WORC) index score. The WORC is a quality of life questionnaire specific to rotator cuff tendinopathy.

Timepoint [1]

Baseline, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [2]

Quality of life: The EQ5D-5L score.

Timepoint [2]

Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [3]

General health status. The EQ-VAS (Visual Analogue Scale) score.

Timepoint [3]

Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [4]

Numeric Pain Rating Scale (0 no pain-10 worst pain) score. Subjective pain intensity measure of patient's shoulder pain at rest, during the preceding week.

Timepoint [4]

Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [5]

Numeric Pain Rating Scale (0 no pain-10 worst pain) score. Subjective pain intensity measure of patient's shoulder pain during activity, during the preceding week.

Timepoint [5]

Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [6]

Shoulder Global Perceived Effect Scale. 5 point Likert Scale. “How is your shoulder now compared to before the surgery?” much worse/ a little worse/ about the same/ a little better/ much better. This question is an adaptation of similar surveys using global perceived change and was created specifically for this study.

Timepoint [6]

6 months, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [7]

Shoulder abduction strength measured by dynamometer.

Timepoint [7]

pre-operatively, 6 months and 12 months post surgery.

Secondary outcome [8]

Work status (normal duties/restricted duties or hours/ not working) data will be collected from the participant directly via electronic (or telephone if required) survey follow up.

Timepoint [8]

Baseline, 6 months and 12 months post surgery.

Secondary outcome [9]

Change from pre-surgery in presence and size of complete rotator cuff tear on MRI.

Timepoint [9]

12 months post surgery.

Secondary outcome [10]

Success of patient blinding fidelity via direct participant questioning. Choice responses : active [repair]/ placebo [no repair]/ unsure.

Timepoint [10]

2 weeks, 6 months, 12 months and 24 months post surgery.

Secondary outcome [11]

Complications (death, frozen shoulder, infection requiring treatment, repeat surgery). Complication data will be collected from the participant directly via electronic (or telephone if required) survey follow up and via reporting from the post surgery treating surgeon.

Timepoint [11]

1-2 weeks, 6-8 weeks, 3 months, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.

Secondary outcome [12]

shoulder external rotation strength measured by dynamometer

Timepoint [12]

pre-operatively, 6 months and 12 months post surgery.

Eligibility

Key inclusion criteria

• Age 45 – 75 years inclusive
• Complete tear of supraspinatus tendon on Magnetic Resonance Imaging (MRI), confirmed at diagnostic arthroscopy as being:
o Complete
o with or without extension into infraspinatus or superior 1/3 of subscapularis tendons
o 1 to 4cm tear in anteroposterior length
o Considered arthroscopically reparable
• At least 6 months duration of shoulder symptoms (regardless of non-operative treatment)
• Rotator cuff repair is considered the primary reason for surgery
• English speaking
• Available for post-operative rehabilitation and for follow up for at least 6 months

Minimum age

45 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Pregnancy
• Tear extending beyond superior 1/3 of subscapularis tendon
• Prior surgery to affected shoulder
• Stage 3 or higher fatty atrophy of infraspinatus and positive Tangent sign according to standardised MRI protocol
• Glenohumeral osteoarthritis (Outerbridge Grade III or higher measured during arthroscopy) or loss of joint space or osteophyte on pre-operative imaging
• Frozen shoulder (>50% loss global passive range) and/or capsular release
• A traumatic tear (more than a fall from standing height) that has occurred within the last six months
• Current use of oral glucocorticoids, immunosuppressants
• Rheumatoid arthritis or other autoimmune inflammatory arthropathy
• Shoulder instability
• Osteonecrosis of the humeral head
• Resident of a residential aged care facility
• Shoulder condition covered by workers’ compensation insurance
• Limited English proficiency or cognitive impairment precluding fully informed consent

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation will use the Interactive Web Response System of the Griffith University Randomisation Service

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will use the technique of minimisation to balance groups for age, surgeon and concomitant procedures.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other

Other design features

The randomised aspect of the study will involve the following two arms: arthroscopic shoulder surgery with rotator cuff repair (intervention) and arthroscopic shoulder surgery without rotator cuff repair (placebo).

An additional observational cohort arm will be recruited; These observational cohort participants are patients who do not consent to be randomised. Participants will receive their usual care by their treating doctor (eg continued physiotherapy or arthroscopic surgery) as decided by patient preference. Outcome data collected, will be the same as per the 2 randomised arms trial with the exception that adverse event reporting and MRI imaging will not be collected.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The sample size used during initial trial registration was based on detecting a 0.5 standard deviation (SD) difference between groups. Recent research has reported the Smallest Worthwhile Effect (SWE) for the ARC study, specifically comparing the two groups used in this trial. The median SWE for improvement in pain and function within 6 months for rotator cuff repair surgery over subacromial decompression alone was 40% and the lower limit of the interquartile range was 20%.

We chose to power the study based on the lower estimate of 20% improvement in the raw WORC score, which converts to 14% change in the final (0–100) WORC based on baseline values in this population (both the SWE study and the ARC study to date). The minimum important difference in the WORC has been reported at similar levels of 13 and 14 points. The SD of the WORC post-rotator cuff tear has been estimated at 17–20. Using a 14-point between-group difference in the WORC at 90% power and a p value of 0.05 and assuming a conservative estimate of 20 for the SD, 86 participants are required (43 in each group). Therefore, we aim to recruit until we have primary outcome (6 months) data for 86 participants.

The observational cohort recruited will be a convenience sample with recruitment to continue until the recruitment period ends.

The primary analysis will consist of an analysis of covariance of the WORC score at 6 months. The model will include the treatment allocation, the baseline WORC score as well as the variables used to stratify the randomisation using minimisation, i.e. age, gender, surgeon and concomitant treatment (acromioplasty and biceps surgery). The effect of the intervention will be estimated as the adjusted mean difference and its 95% confidence interval.

A secondary analysis which includes all WORC measurements will be conducted using a repeated-measures linear mixed model including the treatment allocation, the visit (timepoint), the treatment-by-visit interaction, baseline WORC score, age, gender, surgeon and concomitant treatment. A random subject effect or a repeated effect will be included to model within-subject correlations. A detailed Statistical Analysis Plan will be developed prior to unblinding and database lock. It will include details of the analyses for all outcomes including treatment of missing data, covariate adjustments, subgroup analyses and other pre-specified sensitivity analyses.

The primary analysis will be on an intention to treat basis, with per-protocol and as-treated analyses performed secondarily.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/11/2020

Actual

2/07/2021

Date of last participant enrolment

Anticipated

31/03/2026

Actual

Date of last data collection

Anticipated

30/06/2036

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,VIC

Recruitment hospital [1]

Fairfield Hospital - Prairiewood

Recruitment hospital [2]

St John of God Hospital, Geelong - Geelong

Recruitment hospital [3]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [4]

Shellharbour Hospital - Mount Warrigal

Recruitment hospital [5]

Surgical Treatment and Rehabilitation Service (STARS) - Herston

Recruitment hospital [6]

Ballarat Health Services (Base Hospital) - Ballarat Central

Recruitment postcode(s) [1]

2176 - Prairiewood

Recruitment postcode(s) [2]

3220 - Geelong

Recruitment postcode(s) [3]

2528 - Mount Warrigal

Recruitment postcode(s) [4]

4029 - Herston

Recruitment postcode(s) [5]

3350 - Ballarat Central

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW, Australia

Country [1]

Australia

Primary sponsor type

University

Name

The University of New South Wales

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/04/2020

Approval date [1]

15/06/2020

Ethics approval number [1]

2020/ETH00754

Summary

Brief summary

Shoulder pain in the presence of rotator cuff tear is common and becomes more common with age. Rotator cuff tears are regularly interpreted as the cause for shoulder disability and is frequently treated with arthroscopic surgical repair. There is uncertainty about whether surgical repair provides clinically meaningful benefits to patients with symptoms attributed to their rotator cuff tear.  

Previous trials have shown high rates of re-tears (following repair) at one to two years; the structural integrity of the cuff after surgical repair, does not correlate with clinically important differences in pain or function; and many tears do not progress if left not repaired. Surgical management of rotator cuff tears incurs significant medical and hospital costs and associated surgical risks compared to non-operative management (for example physiotherapy). Therefore, high level evidence comparing surgery to repair the rotator cuff tear versus surgery with no rotator cuff repair (placebo surgery) is required to address practice variation, justification or avoidance of  costs, and to provide the best clinical outcome for patients with these tears.

The aim of this blinded, randomised, parallel group, surgery controlled superiority trial is to: determine the effectiveness, safety and cost-effectiveness of arthroscopic rotator cuff repair compared with placebo (no rotator cuff repair), in improving shoulder pain and function, and quality of life in individuals with symptoms attributed to non-acute, full-thickness rotator cuff tears. 

During this trial it is expected that 86 participants with completed primary outcome data will be randomly allocated to receive either arthroscopic shoulder surgery with rotator cuff tear repair OR arthroscopic shoulder surgery without the rotator cuff tear repair. The trial will also follow patients that are unwilling to be randomised (but consent to follow up) in a separate, observational arm. Inclusion of non-randomised patients provides practice and outcome insights about standard care, and improves the generalisation of the results from the randomised arms.

Trial website

Public notes

Contacts

Principal investigator

Name

Prof Ian Harris

Address

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia Level 2, 1 Campbell St, Liverpool, 2170, NSW, Australia.

Country

Australia

Phone

+61 2 8738 9257

Fax

+61 2 9602 7187

iaharris1@gmail.com

Contact person for public queries

Name

Ian Harris

Address

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia Level 2, 1 Campbell St, Liverpool, 2170, NSW, Australia.

Country

Australia

Phone

+61 2 8738 9257

Fax

+61 2 9602 7187

iaharris1@gmail.com

Contact person for scientific queries

Name

Ian Harris

Address

Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia Level 2, 1 Campbell St, Liverpool, 2170, NSW, Australia.

Country

Australia

Phone

+61 2 8738 9257

Fax

+61 2 9602 7187

iaharris1@gmail.com

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers, upon request and contingent to ethics approval.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual de-identified participant data of published results only.

What types of analyses could be done with individual participant data?

• Data will be made available to other researchers. No restrictions will be placed on the analyses performed by other researchers

When can requests for individual participant data be made (start and end dates)?

From:
Immediately following publication, with no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• By emailing the principal investigator (iaharris1@gmail.com).

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically