Magnetic Growth Rods for Early-Onset Scoliosis
(MCGR Trial)
Trial Summary
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 data supports the effectiveness of the treatment MAGEC® Spinal Bracing And Distraction System for early-onset scoliosis?
Research shows that magnetically controlled growing rods, like the MAGEC system, are effective in treating early-onset scoliosis by allowing noninvasive adjustments and maintaining good spinal growth. Studies involving children with this condition have reported positive early results, indicating that the treatment helps improve spinal alignment and manage the condition effectively.12345
What safety information is available for the MAGEC system used in early-onset scoliosis?
The MAGEC system, used for early-onset scoliosis, has shown good results but has also been associated with implant failures and metallosis (metal debris buildup) around the implants. The CE certification was suspended due to performance evidence gaps, and experts recommend careful patient selection and close monitoring to ensure safety.12567
How is the MAGEC treatment different from other treatments for early-onset scoliosis?
What is the purpose of this trial?
A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.
Research Team
Kenneth MC Cheung, MD, FRCS
Principal Investigator
The University of Hong Kong, Department of Orthopaedics and Traumatology
Michael Vitale, MD
Principal Investigator
Columbia University
Eligibility Criteria
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
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
Treatment Details
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