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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: Recruiting NA study of Rotator Cuff Tears and Rotator Cuff Tear, sponsored by ZuriMED Technologies.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2028-04-01 |
| Phase | NA |
What NCT06918041 shows while recruiting
NCT06918041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06918041's enrollment target sits among peer trials
60 13th of 20 higher than 6 of 20 other Rotator Cuff Tears trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tears trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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