NCT06918041 FiberLocker® System Augmentation of Rotator Cuff Repairs
| NCT ID | NCT06918041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ZuriMED Technologies Inc. |
| Condition | Rotator Cuff Tear |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-08-05 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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). 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., 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 15. The subject's condition represents a worker's compensation case 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
Frequently Asked Questions
Who can join the NCT06918041 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 70 Years, studying Rotator Cuff Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06918041 currently recruiting?
Yes, NCT06918041 is actively recruiting participants. Visit ClinicalTrials.gov or contact ZuriMED Technologies Inc. to inquire about joining.
Where is the NCT06918041 trial being conducted?
This trial is being conducted at Chicago, United States, Columbia, United States, Winston-Salem, United States, Medford, United States.
Who is sponsoring the NCT06918041 clinical trial?
NCT06918041 is sponsored by ZuriMED Technologies Inc.. The trial plans to enroll 60 participants.