U.S., June 5 -- ClinicalTrials.gov registry received information related to the study (NCT07005063) titled 'Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation' on May 26.
Brief Summary: 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 1...