RecruitingNot ApplicableNCT06918041

FiberLocker® System Augmentation of Rotator Cuff Repairs

Sponsor

ZuriMED Technologies Inc.

Enrollment

60 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Rotator Cuff Tears Rotator Cuff tear Rotator Cuff Tears of the Shoulder

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

Min Age: 30 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria18

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
Partial rotator cuff repairs
Lafosse grade 3 or higher subscapularis tears
Limited space for implant delivery
FiberLocker® System cannot be used as indicated

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Interventions

DEVICEFiberLocker® 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.