Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Tear, Rotator Cuff Injury, Rotator Cuff Rupture

In brief

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.

Key facts

Study ID: NCT07005063
Run by: ZuriMED Technologies AG
People needed: 50
Starts: 2025-07-03
Expected to finish: 2029-06-30
Last updated by the study team: 2025-07-17

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject requires surgical treatment of a full-thickness rotator cuff tear, according to Balgrist standard procedure
Full-thickness tear of the supraspinatus or combined infraspinatus and supraspinatus
The rotator cuff tear is of traumatic origin.
Subject is ≥ 40 years of age \& ≤ 65 years of age.
Primary rotator cuff repair
Informed Consent signed by the subject
Pre-operative MRI performed

You may not qualify if…

Vulnerable subjects (as defined in ISO 14155)
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
Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
Previous enrolment into the current investigation,
Enrolment of the PI, his/her family members, employees and other dependent persons,
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
Active smoker
History of claustrophobia that would prevent an MRI of the index shoulder
Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
Pregnant or planning to become pregnant during the study period
Breast feeding women
Subject has conditions or circumstances that would interfere with study requirements.
Contraindications and limitations of the MD as described in the IFUs.
Partial rotator cuff tears
History or known allergy or intolerance to polyester
Complete full-thickness subscapularis tears greater than the superior 1/3 of the tendon, with Lafosse grade 3 or greater
Massive rotator cuff tears, tear size equal to or greater than 4 cm in the anterior-posterior dimension or irreparable rotator cuff tear
Limited space or exposure for implant delivery
Structural or pathological condition of the bone or soft tissue that could impair healing.
Intraoperative rotator cuff tear characteristics differ from preoperatively expected characteristics and fulfil one of the abovementioned criteria
Fatty infiltration of the index shoulder rotator cuff muscle > Goutallier Score 2
Corticosteroid injection in the operative shoulder within 6 weeks of operation
Subject shows frozen shoulder/adhesive capsulitis at day of surgery
Cases of moderate to severe osteoarthritis
Patients with inflammatory disease or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, arthropathy)

Where it is running

Balgrist University Hospital — Zurich, Canton of Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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