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ACTIVE NOT RECRUITING
NCT04058561
NA

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

Sponsor: Pediatric Spine Foundation

View on ClinicalTrials.gov

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.

Official title: Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals

Key Details

Gender

All

Age Range

5 Years - 9 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2019-11-01

Completion Date

2027-12-31

Last Updated

2024-10-24

Healthy Volunteers

No

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.

Locations (20)

Children's Hospital Los Angeles

Los Angeles, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, United States

Children's National Health System

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

C.S. Mott Children's Hospital, University of Michigan

Ann Arbor, Michigan, United States

Washington University School of Medicine, St. Louis Children's Hospital

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Shriners Hospitals for Children - Philadelphia

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Campbell Clinic/Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Texas Scottish Rite Hospital

Dallas, Texas, United States

IWK Health Centre

Halifax, Nova Scotia, Canada

Turku University Hospital, Department of Pediatric Orthopaedic Surgery

Turku, Finland

The University of Hong Kong, Department of Orthopaedics and Traumatology

Hong Kong, Hong Kong