Actively Recruiting
FiberLocker® System Augmentation of Rotator Cuff Repairs
Led by ZuriMED Technologies Inc. · Updated on 2025-12-01
60
Participants Needed
4
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the healing process, functional outcomes, and safety of arthroscopic rotator cuff repairs enhanced with the FiberLocker® System, which includes the SpeedPatch® PET implant and the FiberLocker® Instrument SN. This device-based study focuses on patients with full-thickness rotator cuff tears measuring 2 cm or larger who are undergoing primary rotator cuff repair. The main goal is to assess healing through MRI scans at least 6 months after surgery. All participants will receive rotator cuff repair surgery augmented with the FiberLocker® System. This system uses a mechanical approach where a device places non-woven PET fibers into the tendon tissue to support healing. The study includes follow-up periods up to 24 months after surgery to monitor repair quality and patient recovery. During the study, participants will undergo MRI scans before surgery and at minimum 6 months post-operatively to evaluate tendon healing, tendon quality, and other classifications based on imaging. Additional assessments include various shoulder function scores, pain scales, strength and range of motion tests at multiple timepoints up to 24 months after surgery. Researchers will also monitor any adverse events related to the surgery or device over this period to ensure safety and collect comprehensive outcome data.
CONDITIONS
Brief Title
FiberLocker® System Augmentation of Rotator Cuff Repairs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 70 years
- Planning arthroscopic surgery for a full-thickness rotator cuff tear
- Tear size of 2 cm or larger
- Undergoing primary rotator cuff repair
- Preoperative MRI obtained within 1 year before surgery
You will not qualify if you...
- Unable or unwilling to sign informed consent
- Objecting to use of the FiberLocker® System
- Allergy or intolerance to polyester
- Complete full-thickness subscapularis tears greater than upper third of the tendon (Lafosse grade 3+)
- Hamada grade III or higher
- Joint space less than 2 mm in glenohumeral joint on X-ray
- Recurrent shoulder instability
- Corticosteroid injection in operative shoulder within 3 months before surgery
- Inflammatory or autoimmune joint diseases
- Current acute infection near surgical site
- Revision rotator cuff repair
- Pregnant or planning pregnancy during study
- Breastfeeding during study
- Conditions interfering with study requirements
- Intraoperative exclusions: partial rotator cuff repairs, Lafosse grade 3+ subscapularis tears, limited space for implant delivery, inability to use FiberLocker® System as intended
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)
Duration - Up to discharge post-surgery
Participants undergo surgical repair of the rotator cuff tear with augmentation using the FiberLocker® System.
1 surgical visit and immediate post-operative care
Duration - 24 months post-operatively
Participants are followed to assess healing, shoulder function, pain, and adverse events after surgery.
Visits at 2 weeks, 6 months, 12 months, and 24 months post-surgery
Trial Site Locations
Total: 4 locations
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
MedStar Health Research Institute
Columbia, Maryland, United States, 21044
Actively Recruiting
3
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
4
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, United States, 97504
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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