MAGEC® Spinal Bracing And Distraction System for Early-Onset Scoliosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Early-Onset ScoliosisMAGEC® Spinal Bracing And Distraction System - Device
Eligibility
5 - 9
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Early-Onset Scoliosis

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3 years

3 years
Burden of care
Complications
Curve correction
Health related quality of life: questionnaire
Spinal growth

Trial Safety

Trial Design

2 Treatment Groups

16 weeks
1 of 2
6 weeks
1 of 2

Active Control

Experimental Treatment

210 Total Participants · 2 Treatment Groups

Primary Treatment: MAGEC® Spinal Bracing And Distraction System · No Placebo Group · N/A

6 weeks
Device
Experimental Group · 1 Intervention: MAGEC® Spinal Bracing And Distraction System · Intervention Types: Device
16 weeks
Device
ActiveComparator Group · 1 Intervention: MAGEC® Spinal Bracing And Distraction System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Columbia UniversityOTHER
1,297 Previous Clinical Trials
1,613,027 Total Patients Enrolled
Pediatric Spine FoundationLead Sponsor
1 Previous Clinical Trials
106 Total Patients Enrolled
Michael Vitale, MDPrincipal InvestigatorColumbia University
Kenneth MC Cheung, MD, FRCSPrincipal InvestigatorThe University of Hong Kong, Department of Orthopaedics and Traumatology

Eligibility Criteria

Age 5 - 9 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a height of at least 5.0 to 9.9 years.
Spine or rib-based constructs.
References