FiberLocker® System Augmentation of Rotator Cuff Repairs
ZuriMED Technologies Inc. · NCT06918041
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 30–70 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 60
- US sites recruiting
- 4
- Study start
- August 5, 2025
- Record last updated
- July 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: FiberLocker® System (encompassing FiberLocker® Instrument & SpeedPatch® PET)
Conditions: Rotator Cuff Tear; Rotator Cuff Tears; Rotator Cuff Tears of the Shoulder
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Recruiting US locations
Rush University Medical Center
Chicago, IL 60612
Site contact: Ryan Lee · 312-432-2337 · nicholson.research@rushortho.com
MedStar Health Research Institute
Columbia, MD 21044
Site contact: Crisanto Macaraeg · 410-261-8218 · crisanto.l.macaraeg@medstar.net
Wake Forest University
Winston-Salem, NC 27157
Site contact: Rebecca Keith · 336-716-5868 · Becky.Keith@Advocatehealth.org
Southern Oregon Orthopedics Research Foundation
Medford, OR 97504
Site contact: Lindsey Chin · 541-608-2572 · lindseyc@sooresearch.net