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NCT05981833 · ClinicalTrials.gov registry record
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
A clinical trial of Full-thickness Rotator Cuff Tear, sponsored by Arthrex.
- Recruiting
- Registry status
- 120
- Enrollment target
- 4
- Study locations
NCT05981833: Recruiting study of Full-thickness Rotator Cuff Tear, sponsored by Arthrex.
NCT05981833 is a study of Full-thickness Rotator Cuff Tear that is actively recruiting participants, run by Arthrex. The registered enrollment target is 120 participants. The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05981833, a study of Full-thickness Rotator Cuff Tear, is actively recruiting participants, sponsored by Arthrex.
- RECRUITING
- Registry status
- 120 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).
Primary Outcome
MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification) MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)
Conditions Studied
Interventions
- DEVICE Repair with DAA (dermal allograft augmentation)
Study Locations (4)
Arizona
- University of Arizona, Banner Health - Scottsdale
Connecticut
- Orthopaedic & Nuerosurgery Specialists - Greenwich
Oregon
- Southern Oregon Orthopedics Research Foundation - Medford
Tennessee
- Tennessee Orthopedic Foundation for Research Education and Research - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-09-25 |
| Est. Completion | 2026-09-15 |
What NCT05981833 shows while recruiting
NCT05981833 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Full-thickness Rotator Cuff Tear appearing as the primary indexed condition, and to 1 intervention - of which Repair with DAA (dermal allograft augmentation) is the first listed.
NCT05981833 reports a single indexed study location in Arizona, Connecticut, Oregon.
Frequently Asked Questions
What is clinical trial NCT05981833 about?
NCT05981833 is a clinical study titled "Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears". The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).
What is the current status of trial NCT05981833?
This trial is currently recruiting. The enrollment target is 120 participants. The study started on 2023-09-25. Estimated completion is 2026-09-15.
What conditions does trial NCT05981833 study?
This clinical trial studies the following conditions: Full-thickness Rotator Cuff Tear.
What interventions are being tested in trial NCT05981833?
The interventions under investigation include: Repair with DAA (dermal allograft augmentation) (DEVICE).
Who is sponsoring clinical trial NCT05981833?
This trial is sponsored by Arthrex, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05981833 being conducted?
This trial has 4 study locations across Arizona, Connecticut, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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