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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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spine or rib-based constructs

Major curve greater than 50 degrees at time of index surgery

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up3 years

Awards & highlights

No Placebo-Only Group

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

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You have had a surgery that involved placing metal rods or plates in your spine or ribs.

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Your spine is severely curved, measuring more than 50 degrees, at the time of the initial surgery.

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You were diagnosed with scoliosis before the age of 10.

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Only the Dual-rod Magnetically Controlled Growing Rod implantation method will be used.

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

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

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

1,402 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

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