BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Trial Parameters
Brief Summary
This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.
Eligibility Criteria
Inclusion Criteria: 1. Male or female 40 to 70 years old 2. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT): 1. Tear of the supraspinatus and/or infraspinatus tendons 2. Tear size ≥ 2 cm and \< 5 cm 3. Chronic shoulder pain ≥ 3 months 4. Failed non-operative treatment of the index shoulder to include one or all of the following: 1. Oral analgesics 2. Nonsteroidal anti-inflammatory medications (NSAIDs) 3. Corticosteroid injections 4. Activity modifications 5. Physical therapy or home-guided exercises 5. Able to read and understand the study REB/IRB approved Informed Consent Form (ICF) 6. Willing to be available to attend each protocol-required follow-up examination Intraoperative Inclusion Criteria: 1. Full thickness tear of the supraspinatus and/or infraspinatus tendons 2. Tear size ≥ 2 cm and \< 5 cm 3. Able to reapproximate the tendons to cover \> 50% of the footprint on the greater tuberosity