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

Primary Purpose

Early-Onset Scoliosis Deformity of Spine

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MAGEC® Spinal Bracing And Distraction System
Sponsored by
Pediatric Spine Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Onset Scoliosis Deformity of Spine focused on measuring Spinal deformity, early onset scoliosis

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los AngelesRecruiting
  • Rady Children's Hospital - San DiegoRecruiting
  • Children's Hospital ColoradoRecruiting
  • Alfred I. DuPont Hospital for ChildrenRecruiting
  • Children's National Health SystemRecruiting
  • University of FloridaRecruiting
  • Children's Physican Group Orthopaedics/Children's Healthcare of AtlantaRecruiting
  • Johns Hopkins UniversityRecruiting
  • C.S. Mott Children's Hospital, University of MichiganRecruiting
  • Washington University School of Medicine, St. Louis Children's HospitalRecruiting
  • Columbia University Medical CenterRecruiting
  • Rainbow Babies and Children's HospitalRecruiting
  • The Children's Hospital of PhiladelphiaRecruiting
  • Shriners Hospitals for Children - PhiladelphiaRecruiting
  • Medical University of South CarolinaRecruiting
  • Campbell Clinic/Le Bonheur Children's HospitalRecruiting
  • Texas Scottish Rite HospitalRecruiting
  • IWK Health CentreRecruiting
  • Turku University Hospital, Department of Pediatric Orthopaedic SurgeryRecruiting
  • The University of Hong Kong, Department of Orthopaedics and TraumatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

6 weeks

16 weeks

Arm Description

6-week lengthening interval

16-week lengthening interval

Outcomes

Primary Outcome Measures

Spinal growth
T1-S1 growth

Secondary Outcome Measures

Complications
Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other
Curve correction
Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years
Health related quality of life: questionnaire
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.
Burden of care
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.

Full Information

First Posted
August 14, 2019
Last Updated
March 27, 2023
Sponsor
Pediatric Spine Foundation
Collaborators
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT04058561
Brief Title
Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
Acronym
MCGR
Official Title
Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pediatric Spine Foundation
Collaborators
Columbia University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Onset Scoliosis Deformity of Spine
Keywords
Spinal deformity, early onset scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).
Masking
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.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6 weeks
Arm Type
Experimental
Arm Description
6-week lengthening interval
Arm Title
16 weeks
Arm Type
Active Comparator
Arm Description
16-week lengthening interval
Intervention Type
Device
Intervention Name(s)
MAGEC® Spinal Bracing And Distraction System
Intervention Description
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 Outcome Measure Information:
Title
Spinal growth
Description
T1-S1 growth
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Complications
Description
Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other
Time Frame
3 years
Title
Curve correction
Description
Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years
Time Frame
3 years
Title
Health related quality of life: questionnaire
Description
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.
Time Frame
3 years
Title
Burden of care
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Woon
Phone
6266395919
Email
rwoon@childrensspinefoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Tricia St. Hilaire
Phone
4844106413
Email
tsthilaire@childrensspinefoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Vitale, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth MC Cheung, MD, FRCS
Organizational Affiliation
The University of Hong Kong, Department of Orthopaedics and Traumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Yang, BS
Phone
323-361-5139
Email
josyang@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Hannah Omar-Payne, BS
Phone
323-361-2843
Email
hopayne@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Lindsay M Andras, MD
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aileen C Laurente, BA
Phone
858-576-1700
Ext
223376
Email
alaurente@rchsd.org
First Name & Middle Initial & Last Name & Degree
Peter Newton, MD
First Name & Middle Initial & Last Name & Degree
Gregory M Mundis Jr., MD
First Name & Middle Initial & Last Name & Degree
Vidyadhar Upasani, MD
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Vu, BS
Phone
720-777-5809
Email
ThienThanhAngela.Vu@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Florian Miller, BA
Phone
720-777-8026
Email
Florian.Miller@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Sumeet Garg, MD
Facility Name
Alfred I. DuPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petya Yorgova, MS
Phone
302-651-5920
Email
Petya.yorgova@nemours.org
First Name & Middle Initial & Last Name & Degree
Irene Li
Email
Irene.Li@nemours.org
First Name & Middle Initial & Last Name & Degree
Suken Shah, MD
First Name & Middle Initial & Last Name & Degree
Peter Gabos, MD
First Name & Middle Initial & Last Name & Degree
Gina Hennessy, APN
First Name & Middle Initial & Last Name & Degree
Alicia McCarthy, APN
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonise Handy-Richards, CCRP
Phone
202-476-4652
Email
jhandy@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Matthew Oetgen, MD
First Name & Middle Initial & Last Name & Degree
Laurel Blakemore, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johanna Carmona, LPN
Phone
352-273-7343
Email
carmoji@ortho.ufl.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Ihnow, MD
Facility Name
Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Numera Sachwani, MS
Phone
678-686-6864
Email
numera.sachwani@choa.org
First Name & Middle Initial & Last Name & Degree
Simran Gidwani, BS
Phone
678-686-6864
Email
simran.gidwani@choa.org
First Name & Middle Initial & Last Name & Degree
Joshua Murphy, MD
First Name & Middle Initial & Last Name & Degree
Michael Schmitz, MD
First Name & Middle Initial & Last Name & Degree
Nicholas Nicholas, MD
First Name & Middle Initial & Last Name & Degree
Dennis Devito, MD
First Name & Middle Initial & Last Name & Degree
Robert Bruce, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Tran, BS
Phone
410-955-3136
Email
vtran17@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Paul Sponseller, MD
Facility Name
C.S. Mott Children's Hospital, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-4241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahil Jha, BS
Phone
734-232-8652
Email
sahiljha@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Gertrude Ying Li, MD
First Name & Middle Initial & Last Name & Degree
Michelle S. Caird, MD
Facility Name
Washington University School of Medicine, St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Brouillet, BA
Phone
314-454-5233
Email
kbrouillet@wustl.edu
First Name & Middle Initial & Last Name & Degree
Scott Luhmann, MD
First Name & Middle Initial & Last Name & Degree
Brian Kelly, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afrain Boby, MS
Phone
212-305-9367
Email
ab4789@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Hiroko Matsumoto, MA, PhDc
Phone
212-305-5028
Email
hm2174@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Michael G. Vitale, MD, MPH
First Name & Middle Initial & Last Name & Degree
Benjamin D. Roye, MD, MPH
First Name & Middle Initial & Last Name & Degree
David P. Roye, MD
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Pellman, PhD
Phone
216-844-8469
Email
Jason.Pellman@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Christina Hardesty, MD
First Name & Middle Initial & Last Name & Degree
Jochen Son-Hing, MD
First Name & Middle Initial & Last Name & Degree
Michael Glotzbecker, MD
First Name & Middle Initial & Last Name & Degree
Connie Poe-Kochert, CNP
First Name & Middle Initial & Last Name & Degree
Michelle Janas, RN
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arielle Krakow, BA
Phone
267-426-7607
Email
krakowa@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Divya Talwar, PhD, MPH
Phone
215-590-7841
Email
talward@email.chop.edu
First Name & Middle Initial & Last Name & Degree
Jack Flynn, MD
First Name & Middle Initial & Last Name & Degree
Patrick Cahill, MD
First Name & Middle Initial & Last Name & Degree
Jason Anari, MD
Facility Name
Shriners Hospitals for Children - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Yarnell, BA
Phone
215-430-4223
Email
Evan.Yarnall@shrinenet.org
First Name & Middle Initial & Last Name & Degree
Jason Woloff, BS
Phone
215-430-4223
Email
Jason.Woloff@shrinenet.org
First Name & Middle Initial & Last Name & Degree
Amer Samdani, MD
First Name & Middle Initial & Last Name & Degree
Steven Hwang, MD
First Name & Middle Initial & Last Name & Degree
Joshua Pahys, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert F Murphy, MD
Phone
843-792-9542
Email
murphyr@musc.edu
First Name & Middle Initial & Last Name & Degree
William R. Barfield, PhD
Phone
843-792-9542
Email
barfielb@musc.edu
First Name & Middle Initial & Last Name & Degree
Robert F Murphy, MD
Facility Name
Campbell Clinic/Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rowland, BS
Phone
901-287-5413
Email
jrowland@uthsc.edu
First Name & Middle Initial & Last Name & Degree
Karen Romer, RN, BSN
Phone
901-435-5704
Email
kromer@campbell-foundation.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Sawyer, MD
First Name & Middle Initial & Last Name & Degree
Derek Kelly, MD
First Name & Middle Initial & Last Name & Degree
William Warner, MD
Facility Name
Texas Scottish Rite Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna McClung, BS
Phone
214-559-8553
Email
Anna.Mcclung@tsrh.org
First Name & Middle Initial & Last Name & Degree
David Thornberg, BS
Phone
214-559-8569
Email
David.Thornberg@tsrh.org
First Name & Middle Initial & Last Name & Degree
Charles Johnston, MD
First Name & Middle Initial & Last Name & Degree
Brandon Ramo, MD
First Name & Middle Initial & Last Name & Degree
Amy McIntosh, MD
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Bouchard, MSc, CCRP
Phone
902-470-6857
Email
mandy.bouchard@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Jennifer Hurry, MASc, PEng
Phone
902-470-6765
Email
Jennifer.hurry@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Ron El-Hawary, MD, FRCS(C)
Facility Name
Turku University Hospital, Department of Pediatric Orthopaedic Surgery
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Oksanen, RN, MSc
Phone
+358407599395
Email
hanna.oksanen@tyks.fi
First Name & Middle Initial & Last Name & Degree
Ilkka Helenius, MD, Phd
First Name & Middle Initial & Last Name & Degree
Johanna Syvänen, MD
Facility Name
The University of Hong Kong, Department of Orthopaedics and Traumatology
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Wei
Phone
852-2255-4813
Email
jackwei@connect.hku.hk
First Name & Middle Initial & Last Name & Degree
Kenneth Cheung, MD, FRCS
First Name & Middle Initial & Last Name & Degree
Jason Cheung, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
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Results Reference
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Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

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