NCT06918041 FiberLocker® System Augmentation of Rotator Cuff Repairs

Trial Parameters

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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 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.

Eligibility Criteria

Inclusion Criteria: 1. The Subject is between the ages of 30 and 70 years. 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: 1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board. 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.,

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