FiberLocker® System Augmentation of Rotator Cuff Repairs

Launched by ZURIMED TECHNOLOGIES INC. · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special system called the FiberLocker® System to help heal rotator cuff tears in the shoulder. The goal is to find out how well this system works when added to standard surgical repairs of full-thickness rotator cuff tears. Researchers will use MRI scans at least six months after surgery to see if the tear has healed properly. They will also look at other factors, such as how well the shoulder is functioning and how patients feel about their recovery.

To participate in this study, individuals need to be between 30 and 70 years old and planning to have surgery for a full-thickness rotator cuff tear that is at least 2 centimeters in size. There are some conditions that would exclude someone from the trial, such as allergies to certain materials, specific types of shoulder injuries, or current infections. Participants will have the chance to contribute to important research that may improve shoulder surgery outcomes for future patients.

Gender

ALL

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
• 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