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

NCT04058561 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-10-24

No results posted yet for this study

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.

Conditions

  • Early-Onset Scoliosis Deformity of Spine

Interventions

DEVICE

MAGEC® Spinal Bracing And Distraction System

The magnetically controlled growth rod (MCGR) system is a remotely distractible, magnetically controlled growing rod. The remote capabilities allow for less invasive and less time-consuming outpatient distraction visits, which solves many of the problems facing current growing rod technologies. The MCGR system allows for more frequent lengthenings, and the implanted growing rods can be lengthened more often, which allows MCGR to better approximate normal spine growth compared to Traditional Growing Rods.

Sponsors & Collaborators

Principal Investigators

  • Michael Vitale, MD · Columbia University

  • Kenneth MC Cheung, MD, FRCS · The University of Hong Kong, Department of Orthopaedics and Traumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Finland
  • Hong Kong

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058561 on ClinicalTrials.gov