RecruitingNot Applicable

Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears

Canada70 participantsStarted 2018-07-18

Plain-language summary

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established. The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical trial.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptomatic shoulder pain and/ or weakness (regardless of baseline range of motion/ psuedoparalysis) * Massive rotator cuff tear, identified by MRI as being greater than 4 cm in greatest diameter, and involvement of the entire supraspinatus and infraspinatus. * Failure of at least a 3 month trial of non-surgical treatment including physiotherapy and activity modifications * Irreparable tear determined intra-operatively using standard arthroscopic techniques * Informed consent obtained Exclusion Criteria: * Absence of subscapularis muscle insertion, or irreparable subscapularis tear * Advanced rotator cuff tear arthropathy (Hamada Grade 3+) or glenohumeral osteoarthritis (Samilson-Prieto grade 2+) * Acute tears (within 6 months) * Neurologic injury causing paralysis of affected shoulder / arm * Any previous surgery to the affected shoulder * Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery (ASA Grade IV or higher) * Anticipated problems with ability to maintain follow-up in the judgement of the investigators (ie. patients with no fixed address, etc.) * Are there any non-orthopedic comorbidities that put the patient at significant risk?

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The American Shoulder and Elbow Surgeons Shoulder Score (ASES)

Timeframe: 1 year post operative

Trial details

NCT IDNCT03617562

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Patrick Henry, MD, FRCSC

416-967-8701 patrick.henry@sunnybrook.ca

View on ClinicalTrials.gov More Rotator Cuff Tear trials