FiberLocker® System Augmentation of Rotator Cuff Repairs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorZuriMED Technologies Inc.
About this trial
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 criteria
Qualifiers
The Subject is between the ages of 30 and 70 years.
Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
Tear size ≥ 2 cm
Primary rotator cuff repair
Disqualifiers
The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
The Subject objects to the use of the FiberLocker® System
History or known allergy or intolerance to polyester
Complete full-thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
Trial design
Treatments tested in this trial
- FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov