Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.

NCT Number	NCT07005063
Lead Sponsor	ZuriMED Technologies AG
Conditions	Rotator Cuff Tear, Rotator Cuff Injury, Rotator Cuff Rupture
Enrollment	50 participants
Start Date	2025-07-03
Primary Completion	2029-06-30 (estimated)
Study Completion	2029-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-07-17