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Spinal Bracing And Distraction System

MAGEC® Spinal Bracing And Distraction System for Scoliosis(MCGR Trial)

The University of Hong Kong, Department of Orthopaedics and Traumatology, Hong Kong, Hong Kong
MAGEC® Spinal Bracing And Distraction SystemN/ARecruitingLed by Kenneth MC Cheung, MD, FRCSResearch Sponsored by Pediatric Spine Foundation

MCGR Trial 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

MCGR Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have had a surgery that involved placing metal rods or plates in your spine or ribs.
Your spine is severely curved, measuring more than 50 degrees, at the time of the initial surgery.
You were diagnosed with scoliosis before the age of 10.
Only the Dual-rod Magnetically Controlled Growing Rod implantation method will be used.

MCGR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Spinal growth
Secondary outcome measures
Burden of care
Curve correction
+1 more

Awards & Highlights

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

MCGR 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
1,402 Previous Clinical Trials
2,289,911 Total Patients Enrolled
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare facilities are presently participating in this research study within Canada?

"This medical trial is operational across 18 distinct sites, which include Children's National Health System in Washington and Rady Children's Hospital - San Diego. Additionally, there are 15 other clinical institutions that are participating in this study."

Answered by AI

Am I eligible to partake in this scientific experiment?

"This trial is granting entry to 210 children aged between 5 and 9 diagnosed with scoliosis. To be considered for inclusion, applicants must fulfill the following requirements: possess a diagnosis of Early Onset Scoliosis (scoliosis before age 10), have major curvature higher than 50 degrees at time of initial surgery, receive dual-rod Magnetically Controlled Growing Rod implantation only, bear spine or rib-based constructs, and pre/intraoperative halo gravity traction allowed."

Answered by AI

What is the cap on participants for this clinical research experiment?

"Confirmed. According to clinicaltrials.gov, this research project is currently enrolling participants; the trial was first uploaded on November 1st 2019 and has been updated as recently as February 16th 2022. The study needs 210 individuals from 18 different medical centres."

Answered by AI

Is this research endeavor open for enrollment?

"Affirmative. Clinicaltrials.gov records show that this trial is currently enrolling participants; it was initially made available on November 1st 2019 and last revised February 16th 2022. 210 volunteers are required from 18 distinct sites."

Answered by AI

Are senior citizens being considered as participants for this clinical research?

"This study is recruiting participants aged 5 to 9. Additionally, there are 113 trials currently open for people younger than 18 and 89 studies aimed at individuals over the age of 65."

Answered by AI
Recent research and studies
~4 spots leftby Dec 2023