FiberLocker® System Augmentation of Rotator Cuff Repairs
Recruiting now · Not applicable
Conditions studied: Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder
In brief
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument). The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.
Key facts
- Study ID
- NCT06918041
- Run by
- ZuriMED Technologies Inc.
- People needed
- 60
- Starts
- 2025-08-05
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-07-08
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The Subject is between the ages of 30 and 70 years.
- Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
- Tear size ≥ 2 cm
- Primary rotator cuff repair
- Subject preoperative MRI obtained within 1 year prior to surgery
You may not qualify if…
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to the use of the FiberLocker® System
- History or known allergy or intolerance to polyester
- Complete full-thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- Hamada grade III and above
- Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- Recurrent shoulder instability
- Corticosteroid injection in the operative shoulder within three months before surgery
- Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Subjects with current acute infection in the area surrounding the surgical site
- Revision rotator cuff repair
- Pregnant or planning to become pregnant during the study period
- Subject is breastfeeding during the study period
- Subject has conditions or circumstances that would interfere with study requirements
- The subject's condition represents a worker's compensation case
- Intraoperative Exclusion Criteria:
- Partial rotator cuff repairs
- Lafosse grade 3 or higher subscapularis tears
- Limited space for implant delivery
- FiberLocker® System cannot be used as indicated
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- MedStar Health Research Institute — Columbia, Maryland, United States (enrolling)
- Wake Forest University — Winston-Salem, North Carolina, United States (enrolling)
- Southern Oregon Orthopedics Research Foundation — Medford, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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