Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
NCT ID: NCT04058561
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
210 participants
INTERVENTIONAL
2019-11-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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6 weeks
6-week lengthening interval
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.
16 weeks
16-week lengthening interval
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 who cannot abide by the study requirements due to geographical or other similar constraints
5 Years
9 Years
ALL
No
Sponsors
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Columbia University
OTHER
Pediatric Spine Foundation
OTHER
Responsible Party
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Principal Investigators
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Michael Vitale, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Kenneth MC Cheung, MD, FRCS
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong, Department of Orthopaedics and Traumatology
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Rady Children's Hospital - San Diego
San Diego, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
Children's National Health System
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
C.S. Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine, St. Louis Children's Hospital
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Shriners Hospitals for Children - Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Campbell Clinic/Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Texas Scottish Rite Hospital
Dallas, Texas, United States
IWK Health Centre
Halifax, Nova Scotia, Canada
Turku University Hospital, Department of Pediatric Orthopaedic Surgery
Turku, , Finland
The University of Hong Kong, Department of Orthopaedics and Traumatology
Hong Kong, , Hong Kong
Countries
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References
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Corona J, Miller DJ, Downs J, Akbarnia BA, Betz RR, Blakemore LC, Campbell RM Jr, Flynn JM, Johnston CE, McCarthy RE, Roye DP Jr, Skaggs DL, Smith JT, Snyder BD, Sponseller PD, Sturm PF, Thompson GH, Yazici M, Vitale MG. Evaluating the extent of clinical uncertainty among treatment options for patients with early-onset scoliosis. J Bone Joint Surg Am. 2013 May 15;95(10):e67. doi: 10.2106/JBJS.K.00805.
Flynn JM, Matsumoto H, Torres F, Ramirez N, Vitale MG. Psychological dysfunction in children who require repetitive surgery for early onset scoliosis. J Pediatr Orthop. 2012 Sep;32(6):594-9. doi: 10.1097/BPO.0b013e31826028ea.
JAMES JI. Idiopathic scoliosis; the prognosis, diagnosis, and operative indications related to curve patterns and the age at onset. J Bone Joint Surg Br. 1954 Feb;36-B(1):36-49. doi: 10.1302/0301-620X.36B1.36. No abstract available.
Pehrsson K, Larsson S, Oden A, Nachemson A. Long-term follow-up of patients with untreated scoliosis. A study of mortality, causes of death, and symptoms. Spine (Phila Pa 1976). 1992 Sep;17(9):1091-6. doi: 10.1097/00007632-199209000-00014.
Smith JT. The use of growth-sparing instrumentation in pediatric spinal deformity. Orthop Clin North Am. 2007 Oct;38(4):547-52, vii. doi: 10.1016/j.ocl.2007.03.009.
Cheung KM, Cheung JP, Samartzis D, Mak KC, Wong YW, Cheung WY, Akbarnia BA, Luk KD. Magnetically controlled growing rods for severe spinal curvature in young children: a prospective case series. Lancet. 2012 May 26;379(9830):1967-74. doi: 10.1016/S0140-6736(12)60112-3. Epub 2012 Apr 19.
Goldberg CJ, Gillic I, Connaughton O, Moore DP, Fogarty EE, Canny GJ, Dowling FE. Respiratory function and cosmesis at maturity in infantile-onset scoliosis. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2397-406. doi: 10.1097/01.BRS.0000085367.24266.CA.
Thompson GH, Akbarnia BA, Campbell RM Jr. Growing rod techniques in early-onset scoliosis. J Pediatr Orthop. 2007 Apr-May;27(3):354-61. doi: 10.1097/BPO.0b013e3180333eea.
Bess S, Akbarnia BA, Thompson GH, Sponseller PD, Shah SA, El Sebaie H, Boachie-Adjei O, Karlin LI, Canale S, Poe-Kochert C, Skaggs DL. Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients. J Bone Joint Surg Am. 2010 Nov 3;92(15):2533-43. doi: 10.2106/JBJS.I.01471. Epub 2010 Oct 1.
Caldas JC, Pais-Ribeiro JL, Carneiro SR. General anesthesia, surgery and hospitalization in children and their effects upon cognitive, academic, emotional and sociobehavioral development - a review. Paediatr Anaesth. 2004 Nov;14(11):910-5. doi: 10.1111/j.1460-9592.2004.01350.x.
Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
Akbarnia BA, Breakwell LM, Marks DS, McCarthy RE, Thompson AG, Canale SK, Kostial PN, Tambe A, Asher MA; Growing Spine Study Group. Dual growing rod technique followed for three to eleven years until final fusion: the effect of frequency of lengthening. Spine (Phila Pa 1976). 2008 Apr 20;33(9):984-90. doi: 10.1097/BRS.0b013e31816c8b4e.
Feinberg N, Matsumoto H, Hung CW, St Hilaire T, Pawelek J, Sawyer JR, Akbarnia BA, Skaggs DL, Roye BD, Roye DP Jr, Vitale MG. Expert Consensus and Equipoise: Planning a Randomized Controlled Trial of Magnetically Controlled Growing Rods. Spine Deform. 2018 May-Jun;6(3):303-307. doi: 10.1016/j.jspd.2017.11.002.
Other Identifiers
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PSSG0038
Identifier Type: -
Identifier Source: org_study_id
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