RECRUITING

FiberLocker® System Augmentation of Rotator Cuff Repairs

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 SN). 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.

Official Title

FiberLocker® System Augmentation of Rotator Cuff Repairs

Quick Facts

Study Start:2025-08-05
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06918041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The Subject is between the ages of 30 and 70 years.
  2. 2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
  3. 3. Tear size ≥ 2 cm
  4. 4. Primary rotator cuff repair
  5. 5. Subject preoperative MRI obtained within 1 year prior to surgery
  1. 1. The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
  2. 2. The Subject objects to the use of the FiberLocker® System
  3. 3. History or known allergy or intolerance to polyester
  4. 4. Complete full-thickness subscapularis tears of \> than the superior 1/3 of the tendon (Lafosse grade 3 and above)
  5. 5. Hamada grade III and above
  6. 6. Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
  7. 7. Recurrent shoulder instability
  8. 8. Corticosteroid injection in the operative shoulder within three months before surgery
  9. 9. Subjects with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
  10. 10. Subjects with current acute infection in the area surrounding the surgical site
  11. 11. Revision rotator cuff repair
  12. 12. Pregnant or planning to become pregnant during the study period
  13. 13. Subject is breastfeeding during the study period
  14. 14. Subject has conditions or circumstances that would interfere with study requirements

Contacts and Locations

Study Locations (Sites)

MedStar Health Research Institute
Columbia, Maryland, 21044
United States
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, 97504
United States

Collaborators and Investigators

Sponsor: ZuriMED Technologies Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-05
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2025-08-05
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

  • Rotator Cuff Tears
  • Rotator Cuff Repair
  • Augmentation
  • Reinforcement
  • Mechanical Augmentation
  • Rotator Cuff Degeneration

Additional Relevant MeSH Terms

  • Rotator Cuff Tear
  • Rotator Cuff Tears
  • Rotator Cuff Tears of the Shoulder