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Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
NCT04058561 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04058561 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Pennsylvania, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04058561?
The interventions under investigation include: MAGEC® Spinal Bracing And Distraction System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04058561?
This trial is sponsored by Pediatric Spine Foundation, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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