FiberLocker® System Augmentation of Rotator Cuff Repairs

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear; Rotator Cuff Tears; Rotator Cuff Tears of the Shoulder
• Intervention / Treatment: Device: FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Principal Investigator: Nikhil N Verma, MD
      • Contact: Ryan Lee; Phone Number: 312-432-2337; Email: nicholson.research@rushortho.com
      • Sub-Investigator: Grant E Garrigues, MD
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Recruiting
      • Medstar Health Research Institute
      • Contact: Crisanto Macaraeg; Phone Number: 410-261-8218; Email: crisanto.l.macaraeg@medstar.net
      • Principal Investigator: Anand Murthi, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University
      • Principal Investigator: Brian R Waterman, MD
      • Contact: Rebecca Keith; Phone Number: 336-716-5868; Email: Becky.Keith@Advocatehealth.org
  • Oregon
    • Medford, Oregon, United States, 97504
      • Recruiting
      • Southern Oregon Orthopedics Research Foundation
      • Principal Investigator: Patrick Denard, MD
      • Contact: Lindsey Chin; Phone Number: 541-608-2572; Email: lindseyc@sooresearch.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sugaya Classification	The Sugaya Classification based on MRI images is used to evaluate the integrity of a repaired rotator cuff and to assess healing outcomes after a repair. The classification uses a categorial scoring system with grades from Type I to Type V. - Type I: Normal thickness and low signal intensity in all sections; Type II: Normal thickness and high signal intensity; Type III: Insufficient thickness without discontinuity, representing a partial-thickness tear; Type IV: Minor discontinuity (1-2 slices) on both oblique coronal and oblique sagittal images; Type V: Major discontinuity (>2 slices) on both oblique coronal and sagittal images	Minimum 6 months post-operatively
Goutallier Stage	The Goutallier Classification is evaluated using MRI images to assess fatty infiltration and muscle degeneration in the rotator cuff. It has a categorial grading system from stage 0 to 4. Based on MRI images, the investigator classifies the rotator cuff of each subject. Thereby, a higher classification means more fatty infiltration.	Pre-operatively & minimum 6 months post-operatively
Tendon Quality	The tendon quality of each subject is graded based on MRI images using a categorial scoring system. The following classification can be used: Normal, Intact with edema/regularity, Partial tearing and/or abnormal tissue, Complete Tear/Abnormal.	Pre-operatively & minimum 6 months post-operatively
American Shoulder and Elbow Surgeons (ASES) Score	The ASES score is a patient-reported outcome measure survey which is completed by all subjects. It is used to assess shoulder function and pain. Based on the answers, a final score between 0 and 100 can be achieved. Thereby, higher scores indicate better shoulder function and less pain.	Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Single Assessment Numeric Evaluation (SANE) Score	The SANE score is a patient-reported outcome measure used to assess a patient's perception of their shoulder function. It consists of a single question and each subject has to rate their shoulder function on a scale from 0% to 100%. Thereby, higher percentages indicates better shoulder function.	Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Visual Analog Scale for pain (VAS Score)	The VAS Score is a patient-reported outcome measure used to assess pain intensity. All patients rate their pain on a horizontal line ranging from 0 to 10. Thereby, a higher score indicates greater pain intensity.	Pre-operatively, Post-operatively: 2 weeks, 6 months, 12 months, 24 months
Veterans RAND 12-Item Health Survey (VR-12)	The VR-12 is a patient-reported outcome measure assessing physical and mental health of the subjects. Based on their answers, the subjects can reach a score between 0 and 100, with a higher score indicating better health.	Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Range of Motion (ROM) Assessment	The subject's active ROM (based on the objective ASES score) is assessed using a goniometer. During an outpatient visit at the investigators facility, forward flexion, external rotation, abducted external rotation, abducted internal rotation and internal rotation will be evaluated. The unit of measure is degrees. If subjects are unable to return for an in person visit, an optional self-assessment of these range of motion form will be provided for electronic completion.	Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Strength Assessment	The strength of each subject will be evaluated (based on objective ASES) using a manual muscle testing device or other dynamometers. Thereby, external rotation strength, subscapularis strength-belly press and the constant score strength will be evaulated. The unit of measure will be kilograms or pounds.	Pre-operatively, Post-operatively: 6 months, 12 months, 24 months
Constant-Murley Score	The Constant-Murley Score will be assessed optionally. The score requires an outpatient visit at the investigator's facility and covers questions and functional assessments to assess pain, activity levels, range of motion and strength. The range of motion is assessed using a goniometer in degrees and the strength using a manual muscle testing device (or other dynamometers) in kilogram. The subjects can reach points between 0 and 100, whereby a higher score indicates better function.	Pre-operatively, Post-operatively: 6 months, 12 months, 24 months (all optional)
(Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies	(Serious) Adverse Events, (Serious) Adverse Device Effects and Device Deficiencies will be reported by the research staff as soon as they occur.	From the surgical intervention to 24 months postoperatively

Collaborators and Investigators

• Sponsor: ZuriMED Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Rotator Cuff Tears; Augmentation; Rotator Cuff Repair; Reinforcement; Mechanical Augmentation; Rotator Cuff Degeneration
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: ZM102024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No