Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorZuriMED Technologies AG
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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,
Trial design
Treatments tested in this trial
- FiberLocker® System (encompassing SpeedPatch® PET and FiberLocker Instrument® SN)
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
1Balgrist University Hospital8008, ZurichCanton of Zurich, Switzerland
Sponsors and collaborators
ZuriMED Technologies AG
Lead sponsor
Source ClinicalTrials.gov