NCT07005063

Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: ZuriMED Technologies AG · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.

Conditions

• Rotator Cuff Tear
• Rotator Cuff Injury
• Rotator Cuff Rupture

Interventions

Type	Name	Description
DEVICE	FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)	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: 2025-07-03
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2025-06-04
• Last updated: 2025-07-17

Locations

1 site across 1 country: Switzerland