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NCT04914507 · ClinicalTrials.gov registry record · NA
A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
A NA study of Scoliosis Idiopathic, sponsored by Pediatric Spine Foundation.
- Recruiting
- Registry status
- NA
- Development phase
- 106
- Enrollment target
- 12
- Study locations
NCT04914507 is a NA study of Scoliosis Idiopathic that is actively recruiting participants, run by Pediatric Spine Foundation. The registered enrollment target is 106 participants, below the 283-participant average among 5 other Scoliosis Idiopathic trials with a reported enrollment target (63% lower). The trial reports 12 study locations across 12 states.
The verdict
NCT04914507, a NA study of Scoliosis Idiopathic, is actively recruiting participants, sponsored by Pediatric Spine Foundation.
- RECRUITING
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
- 12
- Study locations
Study Summary
Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes. The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically: 1. The effect on three-dimensional spine growth as compared to normal controls 2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity 3. Complications associated with both the procedure and the device
Conditions Studied
Interventions
- DEVICE Anterior Vertebral Body Tethering
Study Locations (12)
District of Columbia
- Children's National Hospital - Washington D.C.
Illinois
- Shriners Children's Chicago - Chicago
Minnesota
- Gillette Children's Specialty Healthcare - Saint Paul
Missouri
- Washington University - St Louis
New York
- Morgan Stanley Childrens Hospital of New York-Presbyterian - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Oregon
- Shriners Children's Portland - Portland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2021-09-09 |
| Est. Completion | 2029-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04914507
The ClinicalTrials.gov registry entry for NCT04914507 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 283-participant average among 5 other Scoliosis Idiopathic trials with a reported enrollment target (63% lower). The listed sponsor is Pediatric Spine Foundation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Scoliosis Idiopathic appearing as the primary indexed condition, and to 1 intervention - of which Anterior Vertebral Body Tethering is the first listed.
NCT04914507 reports 12 study locations spanning 12 distinct geographic areas - top geographies include District of Columbia, Illinois, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04914507 about?
NCT04914507 is a clinical study titled "A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering". Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. ...
What is the current status of trial NCT04914507?
This trial is currently recruiting. It is a NA study. The enrollment target is 106 participants. The study started on 2021-09-09. Estimated completion is 2029-09.
What conditions does trial NCT04914507 study?
This clinical trial studies the following conditions: Scoliosis Idiopathic.
What interventions are being tested in trial NCT04914507?
The interventions under investigation include: Anterior Vertebral Body Tethering (DEVICE).
Who is sponsoring clinical trial NCT04914507?
This trial is sponsored by Pediatric Spine Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04914507 being conducted?
This trial has 12 study locations across District of Columbia, Illinois, Minnesota, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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