Study of FiberLocker System to Support Arthroscopic Repair of Rotator Cuff Tears in Adults Aged 30 to 70

What this Trial Is About

Researchers are evaluating the healing process, functional outcomes, and safety of arthroscopic rotator cuff repairs enhanced with the FiberLocker System, which includes the SpeedPatch PET implant and the FiberLocker Instrument. This study focuses on patients with full-thickness rotator cuff tears measuring 2 cm or more and aims to assess healing primarily through MRI scans at least six months after surgery. Participants will undergo rotator cuff repair surgery augmented with the FiberLocker System device. The implant consists of non-woven PET fibers delivered into the tendon tissue using a specialized instrument. The study includes follow-up assessments at multiple intervals up to 24 months post-operation to evaluate tendon healing, MRI-based classifications, tendon quality, shoulder function, pain levels, range of motion, strength, and any adverse effects related to the device or surgery. During the study, participants will have MRI scans before surgery and at least six months afterward, along with various clinical and patient-reported outcome evaluations before surgery and at 2 weeks, 6 months, 12 months, and 24 months post-surgery. Researchers will monitor healing through imaging and functional scores, while tracking any adverse events or device issues. Participation may last up to approximately 2 years, allowing for comprehensive safety and effectiveness monitoring.

FiberLocker® System Augmentation of Rotator Cuff Repairs