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MAGEC® Spinal Bracing And Distraction System for Scoliosis(MCGR Trial)
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.
- Early-Onset Scoliosis
MCGR Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
MCGR Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
MCGR Trial Design
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Who is running the clinical trial?
- Your spine is severely curved, measuring more than 50 degrees, at the time of the initial surgery.You have had a surgery that involved placing metal rods or plates in your spine or ribs.You were diagnosed with scoliosis before the age of 10.Only the Dual-rod Magnetically Controlled Growing Rod implantation method will be used.
- Group 1: 16 weeks
- Group 2: 6 weeks
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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