Integrity Implant System Post Market Clinical Follow-Up Study
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).
| Condition(s) | Rotator Cuff Tears of the Shoulder |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair). |
| Who can participate | 1. At least 18 years of age 2. Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures. 3. Able to complete all Patient Reported Outcome Measure (PROM) questionnaires. 4. Fully understands study requirements and able to return for all required follow-up visits and assessments. 5. Able to comply with all post-operative physician prescribed rehabilitation instructions. 6. Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention 7. Meets all intended use and indications for use defined within the Integrity Implant Sy |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Anika Therapeutics, Inc. |
| Locations | Tampa, Florida, United States; Fishers, Indiana, United States; Towson, Maryland, United States; Marlton, New Jersey, United States; Greenville, South Carolina, United States; Germantown, Tennessee, United States |
| Start date | 2025-02-01 |
| NCT ID | NCT06741527 |
| Official listing | https://clinicaltrials.gov/study/NCT06741527 |