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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
5/08/2020
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 of surgical repair of non-acute rotator cuff tears of the shoulder in adults
Secondary ID [1] 301145 0
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 317332 0
Condition category
Condition code
Musculoskeletal 315441 315441 0 0
Other muscular and skeletal disorders
Injuries and Accidents 316222 316222 0 0
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 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.
Intervention code [1] 317494 0
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 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] 323704 0
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] 323704 0
6 months post surgery.
Secondary outcome [1] 382661 0
Western Ontario Rotator Cuff (WORC) index score. The WORC is a quality of life questionnaire specific to rotator cuff tendinopathy.
Timepoint [1] 382661 0
Baseline, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [2] 382662 0
Quality of life: The EQ5D-5L score.
Timepoint [2] 382662 0
Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [3] 382667 0
General health status. The EQ-VAS (Visual Analogue Scale) score.
Timepoint [3] 382667 0
Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [4] 382669 0
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] 382669 0
Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [5] 382670 0
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] 382670 0
Baseline, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [6] 382671 0
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] 382671 0
6 months, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [7] 382672 0
Shoulder abduction strength measured by dynamometer.
Timepoint [7] 382672 0
6 months and 12 months post surgery.
Secondary outcome [8] 382677 0
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] 382677 0
Baseline, 6 months and 12 months post surgery.
Secondary outcome [9] 382678 0
Change from pre-surgery in presence and size of complete rotator cuff tear on MRI.
Timepoint [9] 382678 0
12 months post surgery.
Secondary outcome [10] 382688 0
Success of patient blinding fidelity via direct participant questioning. Choice responses : active [repair]/ placebo [no repair]/ unsure.
Timepoint [10] 382688 0
2 weeks and 6 months post surgery.
Secondary outcome [11] 382689 0
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] 382689 0
1-2 weeks, 6-8 weeks, 3 months, 6 months, 12 months, 24 months, 5 years and 10 years post surgery.
Secondary outcome [12] 384578 0
shoulder external rotation strength measured by dynamometer
Timepoint [12] 384578 0
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
• At least 6 months duration of shoulder symptoms (regardless of non-operative treatment)
• English speaking
• Available for post-operative rehabilitation and for follow up for at least 6 months



Minimum age
45 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• 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)
• Significant acromio-clavicular (AC) joint symptoms (defined as AC joint tenderness)
• No trauma to shoulder within last 3 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 voice response system (IVRS) of the NHMRC Clinical Trials Centre.
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.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The study will require 142 participants to have 80% power to detect a minimum clinically important difference of ½ of the standard deviation (distribution-based method) in the primary outcome (WORC) at a significance level of 0.05, allowing for 10% loss to follow up. If study funding and time allow, we will recruit to 90% power (190 participants and 10% loss to follow up).

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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 16618 0
Fairfield Hospital - Prairiewood
Recruitment hospital [2] 16619 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 16620 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 16621 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [5] 16622 0
Canberra Private Hospital - Deakin
Recruitment hospital [6] 16623 0
St John of God Hospital, Geelong - Geelong
Recruitment hospital [7] 16624 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 30214 0
2176 - Prairiewood
Recruitment postcode(s) [2] 30215 0
2229 - Caringbah
Recruitment postcode(s) [3] 30216 0
2050 - Camperdown
Recruitment postcode(s) [4] 30217 0
2109 - Macquarie Park
Recruitment postcode(s) [5] 30218 0
2600 - Deakin
Recruitment postcode(s) [6] 30219 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 305587 0
Charities/Societies/Foundations
Name [1] 305587 0
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW, Australia
Address [1] 305587 0
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia, Locked Bag 7103, Liverpool BC 1871, NSW, Australia
Country [1] 305587 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW
Address
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia, Locked Bag 7103, Liverpool BC 1871, NSW, Australia
Country
Australia
Secondary sponsor category [1] 306391 0
None
Name [1] 306391 0
Address [1] 306391 0
Country [1] 306391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305887 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305887 0
Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 305887 0
Australia
Date submitted for ethics approval [1] 305887 0
29/04/2020
Approval date [1] 305887 0
15/06/2020
Ethics approval number [1] 305887 0
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 190 participants 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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101942 0
Prof Ian Harris
Address 101942 0
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia
Level 2, 1 Campbell St, Liverpool, 2170, NSW, Australia.
Country 101942 0
Australia
Phone 101942 0
+61 2 8738 9257
Fax 101942 0
+61 2 9602 7187
Email 101942 0
iaharris1@gmail.com
Contact person for public queries
Name 101943 0
Prof Ian Harris
Address 101943 0
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia
Level 2, 1 Campbell St, Liverpool, 2170, NSW, Australia.
Country 101943 0
Australia
Phone 101943 0
+61 2 8738 9257
Fax 101943 0
+61 2 9602 7187
Email 101943 0
iaharris1@gmail.com
Contact person for scientific queries
Name 101944 0
Prof Ian Harris
Address 101944 0
Whitlam Orthopaedic Research Centre, Ingham Institute for Applied Medical Research, UNSW Australia
Level 2, 1 Campbell St, Liverpool, 2170, NSW, Australia.
Country 101944 0
Australia
Phone 101944 0
+61 2 8738 9257
Fax 101944 0
+61 2 9602 7187
Email 101944 0
iaharris1@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data of published results only.
When will data be available (start and end dates)?
Immediately following publication, with no end date determined.
Available to whom?
Researchers, upon request and contingent to ethics approval.
Available for what types of analyses?
Data will be made available to other researchers. No restrictions will be placed on the analyses performed by other researchers
How or where can data be obtained?
By emailing the principal investigator (iaharris1@gmail.com).
What supporting documents are/will be available?
No other documents available
Summary results
No Results