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Purpose

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

Eligibility

Eligible Ages
Between 30 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Augmentation of Rotator Cuff Repair using the FiberLocker® System 		All enrolled participants will undergo repair of the rotator cuff tear, with augmentation utilizing the FiberLocker® System.
  • Device: FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)
    The FiberLocker® System is a mechanical augmentation system that includes an implant (SpeedPatch® PET) and an instrument (FiberLocker® Instrument SN) for its attachment. The implant is composed of non-woven PET fibers, and the instrument features a reciprocating needle at its tip, which pushes the individual patch fibers into the underlying tendon tissue.

Recruiting Locations

MedStar Health Research Institute
Columbia 4352053, Maryland 4361885 21044
Contact:
Crisanto Macaraeg
410-261-8218
crisanto.l.macaraeg@medstar.net

More Details

Status
Recruiting
Sponsor
ZuriMED Technologies Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.