Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

NCT ID: NCT07005063

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2029-06-30

Brief Summary

The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.

Conditions

Rotator Cuff Tear; Rotator Cuff Injury; Rotator Cuff Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Augmentation of Rotator Cuff Repair using the FiberLocker System

All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker System.

Group Type: EXPERIMENTAL

FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)

Intervention Type: DEVICE

The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue

Interventions

FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)

The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZuriMED Technologies AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Balgrist University Hospital

Zurich, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

Karl Wieser, Prof. Dr. med.

Role: primary

schulter@balgrist.ch

+41 44 386 30 12

Other Identifiers

SNCTP000006378

Identifier Type: OTHER

Identifier Source: secondary_id

ZM072024

Identifier Type: -

Identifier Source: org_study_id