FiberLocker® augmentation for rotator cuff repair
FiberLocker® System Augmentation of Rotator Cuff Repairs
NA · ZuriMED Technologies Inc. · NCT06918041
This study will test whether adding the FiberLocker® System (SpeedPatch® PET plus FiberLocker® Instrument) to arthroscopic repair improves healing and shoulder function in adults 30–70 with full-thickness rotator cuff tears of at least 2 cm.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | ZuriMED Technologies Inc. (industry) |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT06918041 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter interventional study enrolls adults aged 30–70 undergoing primary arthroscopic repair for full-thickness rotator cuff tears ≥2 cm and uses the FiberLocker® System (SpeedPatch® PET and FiberLocker® Instrument SN) to augment repairs. The primary outcome is tendon healing on MRI at a minimum of six months postoperatively, with secondary measures including Sugaya classification, Goutallier stage, tendon quality on MRI, objective functional scores, and patient-reported outcome measures. Key exclusions include significant subscapularis tears (Lafosse ≥3), advanced joint degeneration (Hamada ≥III or <2 mm joint space), recent corticosteroid injection, recurrent instability, polyester allergy, or inflammatory joint disease. The trial is conducted at Rush University Medical Center, MedStar Health Research Institute, and Wake Forest University.
Who should consider this trial
Good fit: Ideal candidates are adults 30–70 planning a primary arthroscopic repair for a full-thickness rotator cuff tear ≥2 cm with a preoperative MRI within one year and no contraindication to polyester implants.
Not a fit: Patients with advanced shoulder arthritis, large subscapularis tears, active inflammatory joint disease, recent steroid injection, recurrent instability, or a polyester allergy are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, this augmentation could increase tendon healing and reduce re-tear rates, leading to better shoulder function and fewer repeat surgeries.
How similar studies have performed: Other studies of patch or scaffold augmentation, including polyester-based patches, have reported improved healing in small or nonrandomized series, but high-quality randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 3 other locations
- Rush University Medical Center — Chicago, Illinois, United States (RECRUITING)
- MedStar Health Research Institute — Columbia, Maryland, United States (RECRUITING)
- Wake Forest University — Winston-Salem, North Carolina, United States (RECRUITING)
- Southern Oregon Orthopedics Research Foundation — Medford, Oregon, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder, Rotator Cuff Repair, Augmentation, Reinforcement, Mechanical Augmentation, Rotator Cuff Degeneration