Magnetic Growth Rods for Early-Onset Scoliosis

(MCGR Trial)

Recruiting at 19 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

210 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

How is the MAGEC treatment different from other treatments for early-onset scoliosis?

The MAGEC treatment is unique because it uses magnetically controlled rods that can be lengthened non-invasively with an external remote control, avoiding the need for repeated surgeries that traditional growing rods require. ^{1 2 3 6 8}

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Early experience of MAGEC magnetic growing rods in the treatment of early onset scoliosis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The use of magnetically-controlled growing rods to treat children with early-onset scoliosis: early radiological results in 19 children. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

Magnetically controlled growing rod in 13 patients with early-onset scoliosis and spinal improvement. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment of early-onset scoliosis with a hybrid of a concave magnetic driver (magnetic controlled growth rod) and a contralateral passive sliding rod construct with apical control: preliminary report on 17 cases. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Systematic review of the complications associated with magnetically controlled growing rods for the treatment of early onset scoliosis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The impact and surgeon perceptions of the suspension of the CE certification of MAGEC devices on clinical practice. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Magnetically controlled growing rods in the treatment of early-onset scoliosis: a note of caution. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Magnetic Controlled Growth Rods in the Treatment of Scoliosis: Safety, Efficacy and Patient Selection. [2020]