Clinical Trial

FiberLocker® System Augmentation of Rotator Cuff Repairs

Recruiting
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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® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument). 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-reported outcome measures (PROMs) from validated outcome scoring systems.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-04; most recent amendment 2026-07-06.
Status change: Not Yet Recruiting → Recruiting 2025-08-14
Trial Details
NCT Number NCT06918041
Lead Sponsor ZuriMED Technologies Inc.
Conditions Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder
Enrollment 60 participants
Start Date 2025-08-05
Primary Completion 2026-10-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-08