Actively Recruiting
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
Led by ZuriMED Technologies AG · Updated on 2025-07-17
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject requires surgical treatment of a full-thickness rotator cuff tear following Balgrist standard procedure
- Full-thickness tear involves the supraspinatus or combined infraspinatus and supraspinatus
- Tear is caused by trauma
- Age between 40 and 65 years
- First-time rotator cuff repair
- Signed informed consent
- Pre-operative MRI performed
You will not qualify if you...
- Vulnerable subjects as defined in ISO 14155
- Unable to fully understand or decide about participation
- Participating in another investigational drug or device study within 30 days
- Previously enrolled in this study
- Investigator, family, employees, or dependents enrolled
- Unable to follow study procedures or known non-compliance
- Active smoker
- Claustrophobia preventing MRI of the shoulder
- Implanted metal device or implant contraindicating MRI
- Pregnant or planning pregnancy during study
- Breastfeeding women
- Conditions interfering with study requirements
- Contraindications and limitations per device instructions
- Partial rotator cuff tears
- Allergy or intolerance to polyester
- Complete full-thickness subscapularis tears greater than upper third (Lafosse grade 3+)
- Massive rotator cuff tears (≥4 cm) or irreparable tears
- Limited space for implant delivery
- Bone or soft tissue conditions impairing healing
- Intraoperative tear characteristics not matching preoperative expectations
- Fatty infiltration of rotator cuff muscle above Goutallier Score 2
- Corticosteroid injection in operative shoulder within 6 weeks prior
- Frozen shoulder/adhesive capsulitis at surgery day
- Moderate to severe osteoarthritis
- Inflammatory or autoimmune joint diseases
- Diabetes type I or II
- Acute infection near surgical site
- Active infection, osteomyelitis, sepsis, or spreading infection
- Comorbidities making surgery unsafe as determined by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Balgrist University Hospital
Zurich, Canton of Zurich, Switzerland, 8008
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here