Actively Recruiting
FiberLocker® System Augmentation of Rotator Cuff Repairs
Led by ZuriMED Technologies Inc. · Updated on 2025-12-01
60
Participants Needed
4
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FiberLocker® System Augmentation of Rotator Cuff Repairs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 70 years
- Planning to undergo arthroscopic surgery for full-thickness rotator cuff tear
- Tear size of 2 cm or greater
- Primary rotator cuff repair
- Preoperative MRI obtained within 1 year before surgery
You will not qualify if you...
- Unable or unwilling to sign informed consent
- Object to use of the FiberLocker4 System
- Allergy or intolerance to polyester
- Complete full-thickness subscapularis tears greater than the superior one-third (Lafosse grade 3 or above)
- Hamada grade III or above
- Less than 2 mm joint space in the glenohumeral joint on X-ray
- Recurrent shoulder instability
- Corticosteroid injection in the operative shoulder within 3 months before surgery
- Inflammatory or autoimmune joint diseases (e.g., rheumatoid arthritis, lupus)
- Current acute infection near the surgical site
- Revision rotator cuff repair
- Pregnant or planning pregnancy during the study
- Breastfeeding during the study
- Conditions interfering with study requirements
- Partial rotator cuff repairs during surgery
- Lafosse grade 3 or higher subscapularis tears found intraoperatively
- Limited space for implant delivery
- FiberLocker4 System cannot be used as indicated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
MedStar Health Research Institute
Columbia, Maryland, United States, 21044
Actively Recruiting
3
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
4
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, United States, 97504
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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