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NCT05439850 · ClinicalTrials.gov registry record · Phase 4
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
A Phase 4 study of Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT05439850: Recruiting Phase 4 study of Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, sponsored by Henry Ford Health System.
NCT05439850 is a Phase 4 study of Rotator Cuff Tears and Rotator Cuff Tear Arthropathy that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 78 participants, below the 1,277-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05439850, a Phase 4 study of Rotator Cuff Tears and Rotator Cuff Tear Arthropathy, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.
Primary Outcome
absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Ultrasound Imaging
- PROCEDURE arthroscopic rotator cuff repair
- BIOLOGICAL Bioinductive implant
Study Locations (1)
Michigan
- Henry Ford Health - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2029-07-01 |
| Phase | Phase 4 |
What NCT05439850 shows while recruiting
NCT05439850 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,277-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Rotator Cuff Tears appearing as the primary indexed condition, and to 3 interventions - of which Ultrasound Imaging is the first listed.
NCT05439850 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05439850 about?
NCT05439850 is a clinical study titled "Bioinductive Patch for Full-Thickness Rotator Cuff Tears". The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of ...
What is the current status of trial NCT05439850?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 78 participants. The study started on 2022-08-16. Estimated completion is 2029-07-01.
What conditions does trial NCT05439850 study?
This clinical trial studies the following conditions: Rotator Cuff Tears, Rotator Cuff Tear Arthropathy.
What interventions are being tested in trial NCT05439850?
The interventions under investigation include: Ultrasound Imaging (DIAGNOSTIC_TEST), arthroscopic rotator cuff repair (PROCEDURE), Bioinductive implant (BIOLOGICAL).
Who is sponsoring clinical trial NCT05439850?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05439850 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05439850's enrollment target sits among peer trials
78 11th of 20 higher than 10 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.
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