Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals (MCGR)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    210
  • sponsor
    Pediatric Spine Foundation
Updated on 26 March 2022

Summary

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.

Description

The Magnetically Controlled Growing Rod (MCGR) system consists of growing rods similarly implanted as with traditional approaches, but with subsequent noninvasive distractions. The implanted growing rods are magnetically controlled and adjusted outside the body using an external remote controller (ERC) following initial surgical insertion. No incision or anesthesia are used for rod lengthening procedures and they are performed by the surgeon in an outpatient or office setting. The purpose of this study is to determine the effect of a 6-week lengthening interval compared to a 16-week lengthening interval on spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age with a major coronal curve over 50 degrees undergoing MCGR treatment within 3 years.

Details
Condition Early-Onset Scoliosis Deformity of Spine
Treatment MAGEC® Spinal Bracing And Distraction System
Clinical Study IdentifierNCT04058561
SponsorPediatric Spine Foundation
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)
Between 5 and 9 years of age (5.0 to 9.9 years)
Major curve greater than 50 degrees at time of index surgery
Dual-rod Magnetically Controlled Growing Rod implantation only
Spine or rib-based constructs
Pre-operative and intra-operative halo gravity traction is allowed

Exclusion Criteria

Patients with previous spine surgery, including other growth friendly techniques and all previous neurosurgical procedures
Patients who cannot abide by the study requirements due to geographical or other similar constraints
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