Condition: Rotator Cuff Tear · Rotator Cuff Tears · Rotator Cuff Tears of the Shoulder · Sponsor: ZuriMED Technologies Inc.
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.
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| Rush University Medical Center | Chicago, Illinois, United States | Recruiting |
| MedStar Health Research Institute | Columbia, Maryland, United States | Recruiting |
| Wake Forest University | Winston-Salem, North Carolina, United States | Recruiting |
| Southern Oregon Orthopedics Research Foundation | Medford, Oregon, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06918041