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NCT04058561 · ClinicalTrials.gov registry record · NA
Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
A NA study of Early-Onset Scoliosis Deformity of Spine, sponsored by Pediatric Spine Foundation.
- Active
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT04058561 is a NA study of Early-Onset Scoliosis Deformity of Spine that is active but no longer recruiting, run by Pediatric Spine Foundation. The registered enrollment target is 210 participants. The trial reports 20 study locations across 17 states.
The verdict
NCT04058561, a NA study of Early-Onset Scoliosis Deformity of Spine, is active but no longer recruiting, sponsored by Pediatric Spine Foundation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.
Conditions Studied
Interventions
- DEVICE MAGEC® Spinal Bracing And Distraction System
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Rady Children's Hospital - San Diego - San Diego
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
- Shriners Hospitals for Children - Philadelphia - Philadelphia
Other
- Turku University Hospital, Department of Pediatric Orthopaedic Surgery - Turku
- The University of Hong Kong, Department of Orthopaedics and Traumatology - Hong Kong
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Alfred I. DuPont Hospital for Children - Wilmington
District of Columbia
- Children's National Health System - Washington D.C.
Florida
- University of Florida - Gainesville
Georgia
- Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04058561
The ClinicalTrials.gov registry entry for NCT04058561 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pediatric Spine Foundation, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Early-Onset Scoliosis Deformity of Spine appearing as the primary indexed condition, and to 1 intervention - of which MAGEC® Spinal Bracing And Distraction System is the first listed.
NCT04058561 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT04058561 about?
NCT04058561 is a clinical study titled "Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals". A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod trea...
What is the current status of trial NCT04058561?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2019-11-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04058561 study?
This clinical trial studies the following conditions: Early-Onset Scoliosis Deformity of Spine.
What interventions are being tested in trial NCT04058561?
The interventions under investigation include: MAGEC® Spinal Bracing And Distraction System (DEVICE).
Who is sponsoring clinical trial NCT04058561?
This trial is sponsored by Pediatric Spine Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04058561 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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