Integrity Implant System Post Market Clinical Follow-Up Study
Trial Parameters
Brief 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).
Eligibility Criteria
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 System IFUs as applied to rotator cuff tendon tears. These include: Index shoulder rotator cuff tendon tear needs management and protection from injury Index shoulder has no substantial loss of tendon t