FiberLocker® System Augmentation of Rotator Cuff Repairs
NCT ID: NCT06918041
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-05
2028-04-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Augmentation of Rotator Cuff Repair using the FiberLocker® System
All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System.
FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)
The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.
Interventions
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FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)
The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.
Eligibility Criteria
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Inclusion Criteria
2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
3. Tear size ≥ 2 cm
4. Primary rotator cuff repair
5. Subject preoperative MRI obtained within 1 year prior to surgery
Exclusion Criteria
2. The Subject objects to the use of the FiberLocker® System
3. History or known allergy or intolerance to polyester
4. Complete full-thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
5. Hamada grade III and above
6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
7. Recurrent shoulder instability
8. Corticosteroid injection in the operative shoulder within three months before surgery
9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
10. Subjects with current acute infection in the area surrounding the surgical site
11. Revision rotator cuff repair
12. Pregnant or planning to become pregnant during the study period
13. Subject is breastfeeding during the study period
14. Subject has conditions or circumstances that would interfere with study requirements
1. Partial rotator cuff repairs
2. Lafosse grade 3 or higher subscapularis tears
3. Limited space for implant delivery
4. FiberLocker® System cannot be used as indicated
30 Years
70 Years
ALL
No
Sponsors
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ZuriMED Technologies Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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ZM102024
Identifier Type: -
Identifier Source: org_study_id
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