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Spinal Bracing And Distraction System

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

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

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.

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.Check my eligibility

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.See study design

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.

MCGR Trial 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.

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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.

MCGR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Complications

Curve correction

+1 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pediatric Spine FoundationLead Sponsor

1 Previous Clinical Trials

106 Total Patients Enrolled

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,447,049 Total Patients Enrolled

Michael Vitale, MDPrincipal InvestigatorColumbia University

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

Orthopedic Clinics of North AmericaJournal

The Use of Growth-sparing Instrumentation in Pediatric Spinal Deformity

Smith, John T.. 2007. “The Use of Growth-sparing Instrumentation in Pediatric Spinal Deformity”. Orthopedic Clinics of North America. Elsevier BV. doi:10.1016/j.ocl.2007.03.009.

SpineJournal

Long-term Follow-up of Patients with Untreated Scoliosis A Study of Mortality, Causes of Death, and Symptoms

Pehrsson, Kerstin, Sven Larsson, Anders Oden, and Alf Nachemson. 1992. “Long-term Follow-up of Patients with Untreated Scoliosis A Study of Mortality, Causes of Death, and Symptoms”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007632-199209000-00014.

The LancetJournal

Magnetically Controlled Growing Rods for Severe Spinal Curvature in Young Children: A Prospective Case Series

Cheung, Kenneth Man-Chee, Jason Pui-Yin Cheung, Dino Samartzis, Kin-Cheung Mak, Yat-Wa Wong, Wai-Yuen Cheung, Behrooz A Akbarnia, and Keith Dip-Kei Luk. 2012. “Magnetically Controlled Growing Rods for Severe Spinal Curvature in Young Children: A Prospective Case Series”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(12)60112-3.

Pediatric AnesthesiaJournal