NCT03617562 Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears
| NCT ID | NCT03617562 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | Rotator Cuff Tear |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2018-07-18 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2018-07-18 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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?
Contact & Investigator
Patrick Henry, MD, FRCSC
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences
Frequently Asked Questions
Who can join the NCT03617562 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rotator Cuff Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03617562 currently recruiting?
Yes, NCT03617562 is actively recruiting participants. Contact the research team at patrick.henry@sunnybrook.ca for enrollment information.
Where is the NCT03617562 trial being conducted?
This trial is being conducted at Toronto, Canada, Toronto, Canada.
Who is sponsoring the NCT03617562 clinical trial?
NCT03617562 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Patrick Henry, MD, FRCSC at Sunnybrook Health Sciences. The trial plans to enroll 70 participants.