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

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 and all previous neurosurgical procedures
  • 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

ArmDescriptionAssigned 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

Children's National and nearby locations

Children's National Health System
Washington, District of Columbia 20010
Contact:
Jonise Handy-Richards, CCRP
202-476-4652
jhandy@childrensnational.org

More Details

NCT ID
NCT04058561
Status
Recruiting
Sponsor
Children's Spine Foundation

Study Contact

Regina Woon
6266395919
rwoon@childrensspinefoundation.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.