Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation (NCT07005063) | Clinical Trial Compass
RecruitingNot Applicable
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
Switzerland50 participantsStarted 2025-07-03
Plain-language 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.
Who can participate
Age range40 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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