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

Purpose

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.

Condition

Early-Onset Scoliosis Deformity of Spine

Eligibility

Eligible Ages: Between 5 Years and 9 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 - Patients who cannot abide by the study requirements due to geographical or other similar constraints

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)
Masking Description: Radiographs will be uploaded by each site to the coordinating team and will not have access to the information on exposure arms.

Arm Groups

Arm	Description	Assigned Intervention
Experimental 6 weeks	6-week lengthening interval	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.
Active Comparator 16 weeks	16-week lengthening interval	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.

Recruiting Locations

More Details

NCT ID: NCT04058561
Status: Active, not recruiting
Sponsor: Pediatric Spine Foundation

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.