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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years - 9 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04058561
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pediatric Spine Foundation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Vitale, MDKenneth MC Cheung, MD, FRCS
Principal Investigator Affiliation	Columbia UniversityThe University of Hong Kong, Department of Orthopaedics and Traumatology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada, Finland, Hong Kong, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Early-Onset Scoliosis Deformity of Spine

Additional Details

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.

Arms & Interventions

Arms

Experimental: 6 weeks

6-week lengthening interval

Active Comparator: 16 weeks

16-week lengthening interval

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Site Contact

Joshua Yang, BS

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