FiberLocker® System Augmentation of Rotator Cuff Repairs

NCT06918041 | Recruiting

• 1 other identifier: ZM102024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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 Tear; Rotator Cuff Tears; Rotator Cuff Tears of the Shoulder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Healing Evaluation

  The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. A standard shoulder MRI protocol utilizing a minimum of a 1.5 Tesla magnet will be utilized. The cuff integrity will be classified using the 5 categories described by Sugaya et al. Thereby, type IV and V are considered as retear and type I, II, and III as healed. The healing rate will be estimated and reported descriptively, and a 95% confidence interval will be reported assuming a binomial distribution (unless otherwise noted).

  Pre-operatively & minimum 6 months post-operatively

Secondary Outcomes (11)

• Sugaya Classification

  Minimum 6 months post-operatively

• Goutallier Stage

  Pre-operatively & minimum 6 months post-operatively

• Tendon Quality

  Pre-operatively & minimum 6 months post-operatively

• American Shoulder and Elbow Surgeons (ASES) Score

  Pre-operatively, Post-operatively: 6 months, 12 months, 24 months

• Single Assessment Numeric Evaluation (SANE) Score

  Pre-operatively, Post-operatively: 6 months, 12 months, 24 months

Study Arms (1)

Augmentation of Rotator Cuff Repair using the FiberLocker® System

EXPERIMENTAL

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)

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.

Augmentation of Rotator Cuff Repair using the FiberLocker® System

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ZuriMED Technologies Inc.: lead

Study Sites (4)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MedStar Health Research Institute

Columbia, Maryland, 21044, United States

RECRUITING

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Southern Oregon Orthopedics Research Foundation

Medford, Oregon, 97504, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 9, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

US (4)