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

2019-08-21 20:05:49 | BioPortfolio

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.

Study Design

Conditions

Early-Onset Scoliosis Deformity of Spine

Intervention

MAGEC® Spinal Bracing And Distraction System

Location

Children's Hospital Los Angeles
Los Angeles
California
United States
90027

Status

Not yet recruiting

Source

Children's Spine Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-21T20:05:49-0400

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Medical and Biotech [MESH] Definitions

Bone lengthening by gradual mechanical distraction. An external fixation device produces the distraction across the bone plate. The technique was originally applied to long bones but in recent years the method has been adapted for use with mandibular implants in maxillofacial surgery.

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