FiberLocker® System Augmentation of Rotator Cuff Repairs
ZuriMED Technologies Inc.
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.
Eligibility
- Age range
- 30–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The Subject is between the ages of 30 and 70 years. 2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT) 3. Tear size ≥ 2 cm 4. Primary rotator cuff repair 5. Subject preoperative MRI obtained within 1 year prior to surgery Exclusion Criteria: 1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board. 2. The Subject objects to the use of the FiberLocker® System 3. History or known allergy or intolerance to polyester 4. Complete full-thickness subscapularis tears o…
Interventions
- DeviceFiberLocker® 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.
Locations (4)
- Rush University Medical CenterChicago, Illinois
- MedStar Health Research InstituteColumbia, Maryland
- Wake Forest UniversityWinston-Salem, North Carolina
- Southern Oregon Orthopedics Research FoundationMedford, Oregon