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Spinal Bracing And Distraction System

Magnetic Growth Rods for Early-Onset Scoliosis (MCGR Trial)

N/A
Waitlist Available
Led By Michael Vitale, MD
Research Sponsored by Pediatric Spine Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)
Dual-rod Magnetically Controlled Growing Rod implantation only
Must not have
Patients with previous spine surgery, including other growth friendly techniques and all previous neurosurgical procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether 6-week or 16-week intervals are better for spinal growth in Early Onset Scoliosis patients 5-9 years old.

Who is the study for?
This trial is for children aged 5 to 9 with Early Onset Scoliosis and a major spinal curve over 50 degrees. They must be first-time patients for spine surgery, able to follow the study plan, and have dual-rod Magnetically Controlled Growing Rods implanted.
What is being tested?
The study compares two different lengthening intervals (6 weeks vs. 16 weeks) of the MAGEC® Spinal Bracing And Distraction System in managing scoliosis in young patients, observing spinal growth outcomes over three years.
What are the potential side effects?
Potential side effects may include discomfort at the rod site, possible infection risk due to repeated adjustments, or issues related to improper bone growth or alignment from the bracing system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with scoliosis before I turned 10.
Select...
I have a dual-rod magnetically controlled growing rod implant.
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I am between 5 and 9 years old.
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My spine's major curve was over 50 degrees when I had my first surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had spine surgery or any neurosurgical procedures before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Spinal growth
Secondary study objectives
Burden of care
Complications
Curve correction
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 6 weeksExperimental Treatment1 Intervention
6-week lengthening interval
Group II: 16 weeksActive Control1 Intervention
16-week lengthening interval

Find a Location

Who is running the clinical trial?

Pediatric Spine FoundationLead Sponsor
1 Previous Clinical Trials
106 Total Patients Enrolled
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,768,771 Total Patients Enrolled
Michael Vitale, MDPrincipal InvestigatorColumbia University
Kenneth MC Cheung, MD, FRCSPrincipal InvestigatorThe University of Hong Kong, Department of Orthopaedics and Traumatology

Media Library

MAGEC® Spinal Bracing And Distraction System (Spinal Bracing And Distraction System) Clinical Trial Eligibility Overview. Trial Name: NCT04058561 — N/A
Early-Onset Scoliosis Research Study Groups: 16 weeks, 6 weeks
Early-Onset Scoliosis Clinical Trial 2023: MAGEC® Spinal Bracing And Distraction System Highlights & Side Effects. Trial Name: NCT04058561 — N/A
MAGEC® Spinal Bracing And Distraction System (Spinal Bracing And Distraction System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04058561 — N/A
~78 spots leftby Dec 2027
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