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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.

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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.

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

FieldValue
Enrollment Target 210 participants
Start Date 2019-11-01
Est. Completion 2027-12-31
Phase NA

Sponsor

Pediatric Spine Foundation

2 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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