FiberLocker® augmentation for rotator cuff repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective multicenter interventional study enrolls adults aged 30–70 undergoing primary arthroscopic repair for full-thickness rotator cuff tears ≥2 cm and uses the FiberLocker® System (SpeedPatch® PET and FiberLocker® Instrument SN) to augment repairs. The primary outcome is tendon healing on MRI at a minimum of six months postoperatively, with secondary measures including Sugaya classification, Goutallier stage, tendon quality on MRI, objective functional scores, and patient-reported outcome measures. Key exclusions include significant subscapularis tears (Lafosse ≥3), advanced joint degeneration (Hamada ≥III or <2 mm joint space), recent corticosteroid injection, recurrent instability, polyester allergy, or inflammatory joint disease. The trial is conducted at Rush University Medical Center, MedStar Health Research Institute, and Wake Forest University.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The Subject is between the ages of 30 and 70 years.
2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
3. Tear size ≥ 2 cm
4. Primary rotator cuff repair
5. Subject preoperative MRI obtained within 1 year prior to surgery

Exclusion Criteria:

1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
2. The Subject objects to the use of the FiberLocker® System
3. History or known allergy or intolerance to polyester
4. Complete full-thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
5. Hamada grade III and above
6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
7. Recurrent shoulder instability
8. Corticosteroid injection in the operative shoulder within three months before surgery
9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
10. Subjects with current acute infection in the area surrounding the surgical site
11. Revision rotator cuff repair
12. Pregnant or planning to become pregnant during the study period
13. Subject is breastfeeding during the study period
14. Subject has conditions or circumstances that would interfere with study requirements
15. The subject's condition represents a worker's compensation case

Intraoperative Exclusion Criteria:

1. Partial rotator cuff repairs
2. Lafosse grade 3 or higher subscapularis tears
3. Limited space for implant delivery
4. FiberLocker® System cannot be used as indicated

Where it's running

• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• MedStar Health Research Institute
  Columbia, Maryland, United States Recruiting
• Wake Forest University
  Winston-Salem, North Carolina, United States Recruiting
• Southern Oregon Orthopedics Research Foundation
  Medford, Oregon, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.