U.S., April 10 -- ClinicalTrials.gov registry received information related to the study (NCT06918041) titled 'FiberLocker(R) System Augmentation of Rotator Cuff Repairs' on March 06.
Brief Summary: The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker(R) System (encompassing the SpeedPatch(R) PET and the FiberLocker(R) Instrument SN).
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.
The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-repor...