FiberLocker® System Augmentation of Rotator Cuff Repairs

Part of paid clinical trials in Chicago, Illinois.

Sponsor
ZuriMED Technologies Inc.
Study ID
NCT06918041
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Nov 2025
Primary completion
Oct 1, 2026
Completion
Apr 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Healing Evaluation [ Time Frame: Pre-operatively & minimum 6 months post-operatively ]

Locations (4)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Ryan Lee
[email protected]
312-432-2337
Nikhil N Verma, MD (PRINCIPAL_INVESTIGATOR)
Grant E Garrigues, MD (SUB_INVESTIGATOR)
MedStar Health Research InstituteColumbiaMaryland21044
Crisanto Macaraeg
[email protected]
410-261-8218
Anand Murthi, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest UniversityWinston-SalemNorth Carolina27157
Rebecca Keith
[email protected]
336-716-5868
Brian R Waterman, MD (PRINCIPAL_INVESTIGATOR)
Southern Oregon Orthopedics Research FoundationMedfordOregon97504
Lindsey Chin
[email protected]
541-608-2572
Patrick Denard, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Rush University Medical Center· Chicago, ILMedStar Health Research Institute· Columbia, MDWake Forest University· Winston-Salem, NCSouthern Oregon Orthopedics Research Foundation· Medford, OR

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