Post Market Study of the Integrity Implant System for Rotator Cuff Tear Repair and Augmentation

What this Trial Is About

Researchers are evaluating the Integrity Implant System in adults with rotator cuff tears of the shoulder. This study aims to confirm the devices performance, safety, and clinical benefit when used to augment rotator cuff tears, with or without repair. The trial focuses on reducing rotator cuff re-tear rates and improving shoulder function through a prospective, multi-center, single-arm, non-randomized post-market clinical follow-up. Participants will receive the Integrity Implant System during rotator cuff tear surgery, which may involve mini-open or arthroscopic approaches. The study will follow patients for up to 24 months after surgery, assessing repair integrity with MRI at 12 months and monitoring other functional outcomes and safety throughout the study period. During the study, participants will complete questionnaires measuring shoulder function, pain, and quality of life at screening, 6 weeks, 6 months, 12 months, and 24 months post-surgery. MRI scans will evaluate tendon repair quality and tissue regeneration. Safety will be tracked by recording adverse events. Participants need to follow rehabilitation instructions and attend all follow-up visits to support comprehensive evaluation of the implants performance.

Integrity Implant System Post Market Clinical Follow-Up Study