NCT04058561

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Pediatric Spine Foundation · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Early-Onset Scoliosis Deformity of Spine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2019-08-15
• Last updated: 2024-10-24

Locations

20 sites across 4 countries: United States, Canada, Finland, Hong Kong

Regulatory

• FDA-regulated device study