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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: Active NA study of Early-Onset Scoliosis Deformity of Spine, sponsored by Pediatric Spine Foundation.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
T1-S1 growth
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 |
What the registry record for NCT04058561 still lists
NCT04058561 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
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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 NCT04058561's enrollment target sits among peer trials
210 490th of 2000 higher than 1,505 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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