RECRUITING

FiberLocker® System Augmentation of Rotator Cuff Repairs

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.

Conditions

Rotator Cuff TearRotator Cuff TearsRotator Cuff Tears of the Shoulder
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Related Conditions:

Rotator Cuff TearRotator Cuff TearsRotator Cuff Tears of the Shoulder

Study Overview

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Study Details

Study overview

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.

FiberLocker® System Augmentation of Rotator Cuff Repairs

FiberLocker® System Augmentation of Rotator Cuff Repairs

Condition
Rotator Cuff Tear
Intervention / Treatment

-

Contacts and Locations

Columbia

MedStar Health Research Institute, Columbia, Maryland, United States, 21044

Medford

Southern Oregon Orthopedics Research Foundation, Medford, Oregon, United States, 97504

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

30 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ZuriMED Technologies Inc.,

Study Record Dates

2028-04-01