Rotator cuff repair using a FiberLocker patch to reinforce the tendon
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study
This will try a FiberLocker patch to strengthen arthroscopic rotator cuff repairs in adults aged 40–65 with traumatic full‑thickness supraspinatus (± infraspinatus) tears.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | ZuriMED Technologies AG Industry-sponsored |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT07005063 on ClinicalTrials.gov |
What this trial studies
Adults aged 40–65 who require primary arthroscopic repair of traumatic full‑thickness supraspinatus or combined supraspinatus‑infraspinatus tears will receive augmentation with the FiberLocker System (SpeedPatch PET and FiberLocker instrument). The primary focus is safety, recording postoperative adverse events through a 12‑month follow‑up. Efficacy and clinical performance will be measured at 6 weeks, 4.5 months, and 12 months, including MRI assessment of retear rate and standard shoulder function scores. All procedures and follow‑up visits are conducted at Balgrist University Hospital in Zurich.
Who should consider this trial
Good fit: Ideal candidates are adults 40–65 with traumatic full‑thickness supraspinatus or combined supraspinatus‑infraspinatus tears who need a primary arthroscopic repair and have a preoperative MRI.
Not a fit: Patients with non‑traumatic (degenerative) tears, prior rotator cuff repairs, or inability to attend the Zurich surgical center are unlikely to benefit or qualify.
Why it matters
Potential benefit: If successful, the patch could reduce retear rates and improve shoulder function after rotator cuff repair.
How similar studies have performed: Prior studies of patch augmentation for rotator cuff repair have shown mixed but sometimes promising reductions in retear rates, while device-specific evidence for the FiberLocker System is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure 2. Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus 3. The rotator cuff tear is of traumatic origin. 4. Subject is ≥ 40 years of age \& ≤ 65 years of age. 5. Primary rotator cuff repair 6. Informed Consent signed by the subject 7. Pre-operative MRI performed Exclusion Criteria: 1. Vulnerable subjects (as defined in ISO 14155) 2. Subjects who do not have the power of judgement or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate 3. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation, 4. Previous enrolment into the current investigation, 5. Enrolment of the PI, his/her family members, employees and other dependent persons, 6. Inability to follow the procedures of the investigation, or known or suspected non-compliance, e.g. due to language problems, psychological disorders, dementia, drug or alcohol abuse, etc. of the subject 7. Active smoker 8. History of claustrophobia that would prevent an MRI of the index shoulder 9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder 10. Pregnant or planning to become pregnant during the study period 11. Breast feeding women 12. Subject has conditions or circumstances that would interfere with study requirements. 13. Contraindications and limitations of the MD as described in the IFUs. 14. Partial rotator cuff tears 15. History or known allergy or intolerance to polyester 16. Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater 17. Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear 18. Limited space or exposure for implant delivery 19. Structural or pathological condition of the bone or soft tissue that could impair healing. 20. Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria 21. Fatty infiltration of the index shoulder rotator cuff muscle \> Goutallier Score 2 22. Corticosteroid injection in the operative shoulder within 6 weeks of operation 23. Subject shows frozen shoulder/adhesive capsulitis at day of surgery 24. Cases of moderate to severe osteoarthritis 25. Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy) 26. Subjects with diabetes type I or II 27. The subject currently has an acute infection in the area surrounding the surgical site 28. Evidence of active infection, osteomyelitis, sepsis or distant infection which could spread to the index joint. 29. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
Where this trial is running
Zurich, Canton of Zurich
- Balgrist University Hospital — Zurich, Canton of Zurich, Switzerland (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.