Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

Launched by ZURIMED TECHNOLOGIES AG · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to repair full-thickness tears in the rotator cuff, which is a group of muscles and tendons in the shoulder that help with arm movement. The study will evaluate the safety and effectiveness of using a special patch called the FiberLocker System during surgery. Researchers will monitor participants for any complications after the surgery and assess how well the repair works over time, using MRI scans and various tests to measure shoulder function at different points up to a year later.

To be eligible for the trial, participants must be between 40 and 65 years old and have a full-thickness tear in either the supraspinatus tendon or a combination of the infraspinatus and supraspinatus tendons, caused by an injury. Additionally, they need to have a pre-operative MRI and sign an informed consent form. It's important to note that certain conditions or previous treatments may exclude someone from participating, and the trial is not currently recruiting participants. If you or a loved one might be interested, this trial could offer a new option for treating rotator cuff injuries.

Gender

ALL

Eligibility 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.