Study of Rotator Cuff Tendon Repair Using the FiberLocker System Patch to Treat Full-Thickness Tears in Adults Aged 40 to 65

What this Trial Is About

Researchers are evaluating the safety and effectiveness of repairing full-thickness rotator cuff tears using the FiberLocker System, a device designed to augment the repair. This prospective, single-arm pilot study focuses on adult participants aged 40 to 65 years with traumatic rotator cuff tears requiring surgical treatment. The study aims to track postoperative adverse events and the rate of tendon retear over a 12-month period. All participants will undergo surgical repair of their rotator cuff tear, which will be enhanced with the FiberLocker System. This system includes a patch implant made from non-woven PET fibers and an instrument that attaches the patch to the tendon. The treatment will be followed by regular assessments at 6 weeks, 4.5 months, and 12 months after surgery to monitor healing and function. Participants will attend follow-up visits to complete various evaluations including MRI scans to check for retear, as well as several functional performance scores such as the Constant-Murley Score and Visual Analog Scale for pain. Safety will be closely monitored through tracking of adverse events related to both the device and the procedure itself from surgery through one year. This study is sponsored by ZuriMED Technologies AG and is expected to last until mid-2029.

Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation