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NCT05997381 · ClinicalTrials.gov registry record · NA
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
A NA study of Rotator Cuff Tears, sponsored by CONMED Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 268
- Enrollment target
- 1
- Study location
NCT05997381: Recruiting NA study of Rotator Cuff Tears, sponsored by CONMED Corporation.
NCT05997381 is a NA study of Rotator Cuff Tears that is actively recruiting participants, run by CONMED Corporation. The registered enrollment target is 268 participants, below the 1,268-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05997381, a NA study of Rotator Cuff Tears, is actively recruiting participants, sponsored by CONMED Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 268 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.
Primary Outcome
The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.
Conditions Studied
Interventions
- DEVICE Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.
- PROCEDURE Arthroscopic rotator cuff repair
Study Locations (1)
Connecticut
- ConMed - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT05997381 shows while recruiting
NCT05997381 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, below the 1,268-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Rotator Cuff Tears appearing as the primary indexed condition, and to 2 interventions - of which Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. is the first listed.
NCT05997381 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05997381 about?
NCT05997381 is a clinical study titled "BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears". This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.
What is the current status of trial NCT05997381?
This trial is currently recruiting. It is a NA study. The enrollment target is 268 participants. The study started on 2024-01-05. Estimated completion is 2027-06.
What conditions does trial NCT05997381 study?
This clinical trial studies the following conditions: Rotator Cuff Tears.
What interventions are being tested in trial NCT05997381?
The interventions under investigation include: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. (DEVICE), Arthroscopic rotator cuff repair (PROCEDURE).
Who is sponsoring clinical trial NCT05997381?
This trial is sponsored by CONMED Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05997381 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Rotator Cuff Tears
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05997381's enrollment target sits among peer trials
268 4th of 20 higher than 17 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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