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NCT Number: NCT04058561

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

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.

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Key information

Conditions

Early-Onset Scoliosis Deformity of Spine

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre, Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAGEC® Spinal Bracing And Distraction System

Device

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.

Primary outcomes

  1. Spinal growth

    Time frame: 3 years

    T1-S1 growth

Secondary outcomes

  1. Complications

    Time frame: 3 years

    Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other

  2. Curve correction

    Time frame: 3 years

    Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years

  3. Health related quality of life: questionnaire

    Time frame: 3 years

    Early onset scoliosis 24 item questionnaire; This is a patient reported outcome measure for quality of life, parental/financial burden, and satisfaction (4 main domains). There are 11 sub-domains: General health, pain/discomfort, pulmonary function, transfer, physical function, daily living, fatigue/energy level, emotion, parental impact, financial impact, and satisfaction. Within satisfaction, there is child and parent satisfaction. The raw score for each item is from 1-5. This can be turned into scale scores of 0-100. The higher values represent a better outcome. Average sub-domain scores as well as domain scores can be calculated.

  4. Burden of care

    Time frame: 3 years

    Early onset scoliosis 24 item questionnaire;This is a patient reported outcome measure for quality of life, parental/financial burden, and satisfaction (4 main domains). There are 11 sub-domains: General health, pain/discomfort, pulmonary function, transfer, physical function, daily living, fatigue/energy level, emotion, parental impact, financial impact, and satisfaction. Within satisfaction, there is child and parent satisfaction. The raw score for each item is from 1-5. This can be turned into scale scores of 0-100. The higher values represent a better outcome. Average sub-domain scores as well as domain scores can be calculated.

Sponsors and collaborators

Lead sponsor

Pediatric Spine Foundation

Other

Collaborators

  • Columbia University

Registry information

Official study title

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

Acronym: MCGR

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2019
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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