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

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jul 31, 2018

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical techniques for treating patients with massive rotator cuff tears that cannot be repaired in the usual way. One technique is called superior capsular reconstruction (SCR), which is newer and aims to restore shoulder function, while the other is partial repair of the rotator cuff (PRCR), which has been used for a longer time. The goal is to see which method works better for improving shoulder pain and strength in patients who have already tried non-surgical treatments like physical therapy without success.

To participate in this trial, patients should be between 65 and 74 years old, have a significant rotator cuff tear that is at least 4 cm in size, and have had shoulder pain or weakness for some time. They must also have tried non-surgical treatments for at least three months without improvement. Participants will receive either of the two surgical techniques, and their progress will be closely monitored. It's important to note that this study is the first step before a larger trial, and it aims to gather more information about the safety and effectiveness of SCR compared to PRCR.

Gender

ALL

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?