Magnetic Growth Rods for Early-Onset Scoliosis

(MCGR Trial)

Not currently recruiting at 21 trial locations

Overseen By Regina Woon

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Pediatric Spine Foundation

Disqualifiers: Previous spine surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 years

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

I was diagnosed with scoliosis before I turned 10.

I have a dual-rod magnetically controlled growing rod implant.

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

Exclusion Criteria

I have had spine surgery or any neurosurgical procedures before.

Patients who cannot abide by the study requirements due to geographical or other similar constraints

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Surgery

Initial surgical insertion of Magnetically Controlled Growing Rods

1 week

1 visit (in-person)

Treatment

Participants undergo lengthening procedures at either 6-week or 16-week intervals

3 years

Regular visits (outpatient or office setting)

Follow-up

Participants are monitored for spinal growth, curve correction, and quality of life outcomes

3 years

What Are the Treatments Tested in This Trial?

Interventions

• MAGEC® Spinal Bracing And Distraction System

Trial Overview

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.

How Is the Trial Designed?

Group I: 6 weeks Experimental Treatment 1 Intervention

6-week lengthening interval

Group II: 16 weeks Active Control 1 Intervention

16-week lengthening interval

Who Is Running the Clinical Trial?

Pediatric Spine Foundation

Lead Sponsor

Trials

2

Recruited

320+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4232741/

The MAGEC System for Spinal Lengthening in Children ...

The MAGEC system is indicated for use in children aged 2 years and over with scoliosis who need surgery to correct their spinal curvature—for example, when ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7085947/

Magnetic Controlled Growth Rods in the Treatment of Scoliosis

MAGEC is an evolving magnetically controlled growing rod system for the treatment of EOS. After initial implantation, lengthening is achieved non-invasively.

3.

shrinerschildrens.org

shrinerschildrens.org/en/pediatric-care/magec-system

MAGEC System - MAGnetic Expansion Control Spinal ...

Shriners Children's pioneered the use of the MAGEC System for treating early onset scoliosis. · What to Expect Before and After MAGEC Rod Insertion Surgery · MRI ...

4.

josr-online.biomedcentral.com

josr-online.biomedcentral.com/articles/10.1186/s13018-022-03200-7

Magnetically controlled growing rods in the management of ...

The current evidence indicates that MCGR may be effective to distract the spine and model the curve in EOS. Introduction. Early onset scoliosis ...

5.

journalmsr.com

journalmsr.com/magnetically-controlled-growing-rods-use-for-early-onset-scoliosis-management-a-single-center-experience/

Magnetically controlled growing rods' use for early-onset ...

Magnetically controlled growing rods' use for early-onset scoliosis management: A single-center experience.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8521516/

Identifying complications and failure modes of innovative ...

Spring distraction system for early onset scoliosis provides continuous distraction without a potential increase in rod fractures, compared to traditional ...

7.

spinalsurgerynews.com

spinalsurgerynews.com/2019/05/the-safety-and-performance-of-magnetically-controlled-growth-rods-for-treatment-of-early-onset-scoliosis/39310

The safety and performance of Magnetically Controlled ...

The safety and performance of Magnetically Controlled Growth Rods for treatment of Early Onset Scoliosis ... system for spinal lengthening ...

8.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K233593.pdf

NuVasive Specialized Orthopedics, Incorporated Miriam ...

The MAGEC Spinal Bracing and. Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities. (e.g. ...

9.

thespinemarketgroup.com

thespinemarketgroup.com/managing-early-onset-scoliosis-which-growth-preserving-treatments-are-clinically-approved-exploring-innovations-and-the-future-of-eos-management/

Managing Early-Onset Scoliosis: Which Growth-Preserving ...

Evidence comes from animal studies showing significant correction within weeks, as well as early European reports suggesting promising outcomes, ...