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

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ClinicalTrials.gov Identifier: NCT04058561
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Pediatric Spine Foundation

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.

Condition or disease Intervention/treatment Phase
Early-Onset Scoliosis Deformity of Spine Device: MAGEC® Spinal Bracing And Distraction System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
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).
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.
Primary Purpose: Treatment
Official Title: Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Spinal growth [ Time Frame: 3 years ]
    T1-S1 growth


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 and all previous neurosurgical procedures
  • Patients who cannot abide by the study requirements due to geographical or other similar constraints

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058561


Contacts
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Contact: Regina Woon 6266395919 rwoon@childrensspinefoundation.org
Contact: Tricia St. Hilaire 4844106413 tsthilaire@childrensspinefoundation.org

Locations
Show Show 21 study locations
Sponsors and Collaborators
Pediatric Spine Foundation
Columbia University
Investigators
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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:

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Responsible Party: Pediatric Spine Foundation
ClinicalTrials.gov Identifier: NCT04058561    
Other Study ID Numbers: PSSG0038
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Pediatric Spine Foundation:
Spinal deformity, early onset scoliosis
Additional relevant MeSH terms:
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Scoliosis
Congenital Abnormalities
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases