BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
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.
| Condition(s) | Rotator Cuff Tears |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | CONMED Corporation |
| Locations | New Haven, Connecticut, United States |
| Start date | 2024-01-05 |
| NCT ID | NCT05997381 |
| Official listing | https://clinicaltrials.gov/study/NCT05997381 |