Magnetic Growth Rods for Early-Onset Scoliosis
(MCGR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the best timing for lengthening magnetic growth rods in children with early-onset scoliosis, a condition where the spine curves before age 10. It compares the effects of lengthening the rods every 6 weeks versus every 16 weeks to assess which schedule promotes better spinal growth over three years. Children aged 5 to 9 with a major spinal curve over 50 degrees who use these specific magnetic rods (MAGEC® Spinal Bracing And Distraction System) may be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of optimal treatment timing for young patients with scoliosis.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the MAGEC® Spinal Bracing And Distraction System is safe for children with early-onset scoliosis?
Research has shown that the MAGEC Spinal Bracing and Distraction System is generally well-tolerated by patients. Studies have found that these magnetic rods, used for children with early-onset scoliosis, can be adjusted as the child grows. This adjustment helps prevent the spine's curve from worsening without frequent surgeries.
Regarding safety, previous findings suggest that the MAGEC rods can lengthen the spine over time without increasing the risk of breaking, a common concern with traditional rods. While not completely risk-free, these rods are designed to reduce complications. Some reports have mentioned issues like rods moving out of place, but these occurrences are relatively rare.
Overall, the available evidence supports the safety of the MAGEC system in managing early-onset scoliosis. However, like any medical treatment, potential risks should be considered.12345Why are researchers excited about this trial?
Researchers are excited about the MAGEC® Spinal Bracing and Distraction System for early-onset scoliosis because it offers a unique, non-invasive approach to spinal correction. Unlike traditional growth rods that require repeated surgeries to adjust, the MAGEC® system uses magnetic technology to lengthen the rods externally, reducing the need for multiple surgeries. This approach can significantly decrease the physical and emotional burden on young patients and their families. Additionally, the trial is comparing different lengthening intervals, which could optimize treatment schedules and further enhance patient outcomes.
What evidence suggests that the MAGEC® Spinal Bracing And Distraction System is effective for early-onset scoliosis?
Research has shown that the MAGEC® system, a special type of growing rod controlled by magnets, effectively treats early-onset scoliosis. Studies have found that it can help straighten a child's spine by slowly lengthening the rods without repeated surgeries. This trial will compare two different lengthening intervals: 6 weeks and 16 weeks. The system is particularly beneficial because it allows for adjustments without surgery, easing the process for children and their families. Evidence suggests that MAGEC effectively manages spinal curvature, offering a promising option for young patients with severe scoliosis. Many centers have used the system successfully, demonstrating positive results in managing spinal growth.26789
Who Is on the Research Team?
Michael Vitale, MD
Principal Investigator
Columbia University
Kenneth MC Cheung, MD, FRCS
Principal Investigator
The University of Hong Kong
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Surgery
Initial surgical insertion of Magnetically Controlled Growing Rods
Treatment
Participants undergo lengthening procedures at either 6-week or 16-week intervals
Follow-up
Participants are monitored for spinal growth, curve correction, and quality of life outcomes
What Are the Treatments Tested in This Trial?
Interventions
- MAGEC® Spinal Bracing And Distraction System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pediatric Spine Foundation
Lead Sponsor
Columbia University
Collaborator