Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
| Condition(s) | Rotator Cuff Injuries |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears. |
| Who can participate | Inclusion Criteria: * The subject must provide written informed consent. * Subject is \> eighteen (18) years of age (no upper limit). * Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus. * Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear. * Subject willing and able to make all required study visits. * Subject able to follow instructions and deemed capable of completing all study questionnaires. Exclusion Criteria: * Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system. * Subjects where the prescribed Physical Therapy guid |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Smith & Nephew, Inc. |
| Locations | Rome, Georgia, United States; Rockford, Illinois, United States; Baltimore, Maryland, United States; Garfield Heights, Ohio, United States; Pittsburgh, Pennsylvania, United States; Bedford, Texas, United States (+14 more sites) |
| Start date | 2022-08-30 |
| NCT ID | NCT05444465 |
| Official listing | https://clinicaltrials.gov/study/NCT05444465 |