Actively Recruiting
Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation: A Prospective, Single-Arm, Non-Randomized, Pilot Study
Led by ZuriMED Technologies AG · Updated on 2025-07-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of repairing full-thickness rotator cuff tears using the FiberLocker System, a device designed to augment the repair. This prospective, single-arm pilot study focuses on adult participants aged 40 to 65 years with traumatic rotator cuff tears requiring surgical treatment. The study aims to track postoperative adverse events and the rate of tendon retear over a 12-month period. All participants will undergo surgical repair of their rotator cuff tear, which will be enhanced with the FiberLocker System. This system includes a patch implant made from non-woven PET fibers and an instrument that attaches the patch to the tendon. The treatment will be followed by regular assessments at 6 weeks, 4.5 months, and 12 months after surgery to monitor healing and function. Participants will attend follow-up visits to complete various evaluations including MRI scans to check for retear, as well as several functional performance scores such as the Constant-Murley Score and Visual Analog Scale for pain. Safety will be closely monitored through tracking of adverse events related to both the device and the procedure itself from surgery through one year. This study is sponsored by ZuriMED Technologies AG and is expected to last until mid-2029.
CONDITIONS
Brief 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
- Full-thickness tear involving the supraspinatus or combined supraspinatus and infraspinatus
- Rotator cuff tear is due to trauma
- Age between 40 and 65 years inclusive
- Primary rotator cuff repair
- Signed informed consent
- Pre-operative MRI performed
You will not qualify if you...
- Vulnerable subjects as defined by ISO 14155
- Unable to understand or judge participation aspects
- Participation in another investigational drug or device study within 30 days
- Previous enrollment in this study
- Enrollment of investigator or related persons
- Inability or non-compliance with study procedures
- Active smoker
- Claustrophobia preventing MRI of the shoulder
- Presence of metal implants or devices contraindicating MRI
- Pregnant or planning pregnancy during the study
- Breastfeeding women
- Conditions interfering with study requirements
- Contraindications per device instructions for use
- Partial rotator cuff tears
- Allergy or intolerance to polyester
- Complete subscapularis tears greater than one-third of tendon
- Massive or irreparable rotator cuff tears
- Limited space for implant delivery
- Bone or soft tissue conditions impairing healing
- Unexpected intraoperative tear characteristics meeting exclusion
- Fatty infiltration of rotator cuff muscles greater than Goutallier score 2
- Corticosteroid injection in operative shoulder within 6 weeks
- Frozen shoulder or adhesive capsulitis at surgery
- Moderate to severe osteoarthritis
- Autoimmune or inflammatory joint diseases
- Diabetes type I or II
- Acute infection near surgical site
- Active or systemic infections affecting joint
- Any condition making patient a poor surgical candidate as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for pre-operative MRI and assessment
Duration - Day of surgery plus immediate recovery period
Participants undergo repair of the rotator cuff tear with augmentation using the FiberLocker System device.
1 surgery visit (in-person)
Duration - 12 months
Participants have follow-up visits to monitor recovery, assess tendon healing, pain, and shoulder function over 12 months.
Visits at 2 weeks, 6 weeks, 4.5 months, and 12 months (in-person)
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
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