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

April 1, 2024 updated by: Pediatric Spine Foundation

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
  • Finland
      • Turku, Finland, 20521
        • Recruiting
        • Turku University Hospital, Department of Pediatric Orthopaedic Surgery
        • Contact:
        • Principal Investigator:
          • Ilkka Helenius, MD, Phd
        • Sub-Investigator:
          • Johanna Syvänen, MD
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The University of Hong Kong, Department of Orthopaedics and Traumatology
        • Contact:
        • Principal Investigator:
          • Kenneth Cheung, MD, FRCS
        • Sub-Investigator:
          • Jason Cheung, MBBS
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • Lindsay M Andras, MD
        • Contact:
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
        • Principal Investigator:
          • Peter Newton, MD
        • Sub-Investigator:
          • Gregory M Mundis Jr., MD
        • Sub-Investigator:
          • Vidyadhar Upasani, MD
    • Colorado
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I. DuPont Hospital for Children
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suken Shah, MD
        • Sub-Investigator:
          • Peter Gabos, MD
        • Sub-Investigator:
          • Gina Hennessy, APN
        • Sub-Investigator:
          • Alicia McCarthy, APN
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Health System
        • Contact:
        • Principal Investigator:
          • Matthew Oetgen, MD
        • Sub-Investigator:
          • Laurel Blakemore, MD
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Stephanie Ihnow, MD
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joshua Murphy, MD
        • Sub-Investigator:
          • Michael Schmitz, MD
        • Sub-Investigator:
          • Nicholas Nicholas, MD
        • Sub-Investigator:
          • Dennis Devito, MD
        • Sub-Investigator:
          • Robert Bruce, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Paul Sponseller, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-4241
        • Recruiting
        • C.S. MOTT Children's Hospital, University of Michigan
        • Contact:
        • Principal Investigator:
          • Gertrude Ying Li, MD
        • Sub-Investigator:
          • Michelle S. Caird, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine, St. Louis Children's Hospital
        • Contact:
        • Principal Investigator:
          • Scott Luhmann, MD
        • Sub-Investigator:
          • Brian Kelly, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Principal Investigator:
          • Michael G. Vitale, MD, MPH
        • Sub-Investigator:
          • Benjamin D. Roye, MD, MPH
        • Sub-Investigator:
          • David P. Roye, MD
        • Contact:
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Rainbow Babies and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Christina Hardesty, MD
        • Sub-Investigator:
          • Jochen Son-Hing, MD
        • Sub-Investigator:
          • Michael Glotzbecker, MD
        • Sub-Investigator:
          • Connie Poe-Kochert, CNP
        • Sub-Investigator:
          • Michelle Janas, RN
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • The Children's Hospital of Philadelphia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jack Flynn, MD
        • Sub-Investigator:
          • Patrick Cahill, MD
        • Sub-Investigator:
          • Jason Anari, MD
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Shriners Hospitals for Children - Philadelphia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amer Samdani, MD
        • Sub-Investigator:
          • Steven Hwang, MD
        • Sub-Investigator:
          • Joshua Pahys, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert F Murphy, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Recruiting
        • Campbell Clinic/Le Bonheur Children's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey Sawyer, MD
        • Sub-Investigator:
          • Derek Kelly, MD
        • Sub-Investigator:
          • William Warner, MD
    • Texas
      • Dallas, Texas, United States, 75219
        • Recruiting
        • Texas Scottish Rite Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Johnston, MD
        • Sub-Investigator:
          • Brandon Ramo, MD
        • Sub-Investigator:
          • Amy McIntosh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal growth
Time Frame: 3 years
T1-S1 growth
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 years
Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other
3 years
Curve correction
Time Frame: 3 years
Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years
3 years
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatric Spine Foundation

Collaborators

Columbia University

Investigators

  • Principal Investigator: Michael Vitale, MD, Columbia University
  • Principal Investigator: Kenneth MC Cheung, MD, FRCS, The University of Hong Kong, Department of Orthopaedics and Traumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSSG0038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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