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NCT06918041 · ClinicalTrials.gov registry record · NA

FiberLocker® System Augmentation of Rotator Cuff Repairs

A NA study of Rotator Cuff Tears and Rotator Cuff Tear, sponsored by ZuriMED Technologies.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
4
Study locations

NCT06918041 is a NA study of Rotator Cuff Tears and Rotator Cuff Tear that is actively recruiting participants, run by ZuriMED Technologies. The registered enrollment target is 60 participants, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT06918041, a NA study of Rotator Cuff Tears and Rotator Cuff Tear, is actively recruiting participants, sponsored by ZuriMED Technologies.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
4
Study locations

Study 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.

Interventions

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

Study Locations (4)

Illinois

  • Rush University Medical Center - Chicago

Maryland

  • MedStar Health Research Institute - Columbia

North Carolina

  • Wake Forest University - Winston-Salem

Oregon

  • Southern Oregon Orthopedics Research Foundation - Medford

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-08-05
Est. Completion 2028-04-01
Phase NA

Sponsor

ZuriMED Technologies

1 total trials

What the Registry Record Tells You About NCT06918041

The ClinicalTrials.gov registry entry for NCT06918041 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower). The listed sponsor is ZuriMED Technologies, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET) is the first listed.

NCT06918041 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Illinois, Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06918041 about?

NCT06918041 is a clinical study titled "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 evaluati...

What is the current status of trial NCT06918041?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-08-05. Estimated completion is 2028-04-01.

What conditions does trial NCT06918041 study?

This clinical trial studies the following conditions: Rotator Cuff Tears, Rotator Cuff Tear, Rotator Cuff Tears of the Shoulder.

What interventions are being tested in trial NCT06918041?

The interventions under investigation include: FiberLocker® System (encompassing FiberLocker® Instrument SN & SpeedPatch® PET) (DEVICE).

Who is sponsoring clinical trial NCT06918041?

This trial is sponsored by ZuriMED Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06918041 being conducted?

This trial has 4 study locations across Illinois, Maryland, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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