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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.
Age
30 - 70 years
Sex
ALL
Healthy Volunteers
No
Rush University Medical Center
Chicago, Illinois, United States
MedStar Health Research Institute
Columbia, Maryland, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, United States
Start Date
August 5, 2025
Primary Completion Date
October 1, 2026
Completion Date
April 1, 2028
Last Updated
December 1, 2025
60
ESTIMATED participants
FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)
DEVICE
Lead Sponsor
ZuriMED Technologies Inc.
NCT04944836
NCT06735170
NCT07057037
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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