NCT06918041

FiberLocker® System Augmentation of Rotator Cuff Repairs

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: ZuriMED Technologies Inc. · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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 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-reported outcome measures (PROMs) from validated outcome scoring systems.

Conditions

• Rotator Cuff Tear
• Rotator Cuff Tears
• Rotator Cuff Tears of the Shoulder

Interventions

Type	Name	Description
DEVICE	FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)	The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.

Timeline

• Start date: 2025-08-05
• Primary completion: 2026-10-01
• Completion: 2028-04-01
• First posted: 2025-04-09
• Last updated: 2025-12-01

Locations

4 sites across 1 country: United States