FiberLocker® System Augmentation of Rotator Cuff Repairs

ZuriMED Technologies Inc.

Status: Enrolling

Conditions: Rotator Cuff Tear; Rotator Cuff Tears of the Shoulder; Rotator Cuff Tears

Treatments: Device: FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06918041

ZM102024

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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., 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

Intraoperative Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Augmentation of Rotator Cuff Repair using the FiberLocker® System

Experimental group

Description:

All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System.

Treatment:

Device: FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)