Status:
RECRUITING
FiberLocker® System Augmentation of Rotator Cuff Repairs
Lead Sponsor:
ZuriMED Technologies Inc.
Conditions:
Rotator Cuff Tear
Rotator Cuff Tears
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief 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 S...
Eligibility Criteria
Inclusion
- 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
- Subject preoperative MRI obtained within 1 year prior to surgery
Exclusion
- 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)
- Hamada grade III and above
- Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- Recurrent shoulder instability
- Corticosteroid injection in the operative shoulder within three months before surgery
- Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Subjects with current acute infection in the area surrounding the surgical site
- Revision rotator cuff repair
- Pregnant or planning to become pregnant during the study period
- Subject is breastfeeding during the study period
- Subject has conditions or circumstances that would interfere with study requirements
- Intraoperative
Key Trial Info
Start Date :
August 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06918041
Start Date
August 5 2025
End Date
April 1 2028
Last Update
December 1 2025
Active Locations (4)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
MedStar Health Research Institute
Columbia, Maryland, United States, 21044
3
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
4
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, United States, 97504