None listed
Conditions
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.
Interventions
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
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.
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
No
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
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
Outcome results
None listed