Study Summary
This trial will study whether 6-week or 16-week intervals are better for spinal growth in Early Onset Scoliosis patients 5-9 years old.
Eligible Conditions
- Early-Onset Scoliosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 3 years
3 years
Burden of care
Complications
Curve correction
Health related quality of life: questionnaire
Spinal growth
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
16 weeks
1 of 2
6 weeks
1 of 2
Active Control
Experimental Treatment
210 Total Participants · 2 Treatment Groups
Primary Treatment: MAGEC® Spinal Bracing And Distraction System · No Placebo Group · N/A
6 weeks
Device
Experimental Group · 1 Intervention: MAGEC® Spinal Bracing And Distraction System · Intervention Types: Device16 weeks
Device
ActiveComparator Group · 1 Intervention: MAGEC® Spinal Bracing And Distraction System · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Who is running the clinical trial?
Columbia UniversityOTHER
1,297 Previous Clinical Trials
1,613,027 Total Patients Enrolled
Pediatric Spine FoundationLead Sponsor
1 Previous Clinical Trials
106 Total Patients Enrolled
Michael Vitale, MDPrincipal InvestigatorColumbia University
Kenneth MC Cheung, MD, FRCSPrincipal InvestigatorThe University of Hong Kong, Department of Orthopaedics and Traumatology
Eligibility Criteria
Age 5 - 9 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a height of at least 5.0 to 9.9 years.
Spine or rib-based constructs.
References
- Smith, John T.. 2007. “The Use of Growth-sparing Instrumentation in Pediatric Spinal Deformity”. Orthopedic Clinics of North America. Elsevier BV. doi:10.1016/j.ocl.2007.03.009.
- Pehrsson, Kerstin, Sven Larsson, Anders Oden, and Alf Nachemson. 1992. “Long-term Follow-up of Patients with Untreated Scoliosis A Study of Mortality, Causes of Death, and Symptoms”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00007632-199209000-00014.
- Cheung, Kenneth Man-Chee, Jason Pui-Yin Cheung, Dino Samartzis, Kin-Cheung Mak, Yat-Wa Wong, Wai-Yuen Cheung, Behrooz A Akbarnia, and Keith Dip-Kei Luk. 2012. “Magnetically Controlled Growing Rods for Severe Spinal Curvature in Young Children: A Prospective Case Series”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(12)60112-3.
- Caldas, Jose Carlos S., Jose Luis Pais-Ribeiro, and Silvestre R. Carneiro. 2004. “General Anesthesia, Surgery and Hospitalization in Children and Their Effects Upon Cognitive, Academic, Emotional and Sociobehavioral Development - a Review”. Pediatric Anesthesia. Wiley. doi:10.1111/j.1460-9592.2004.01350.x.
- Kain, Zeev N.. 1996. “Preoperative Anxiety in Children”. Archives of Pediatrics & Adolescent Medicine. American Medical Association (AMA). doi:10.1001/archpedi.1996.02170370016002.
- Flynn, John M., Hiroko Matsumoto, Frances Torres, Norman Ramirez, and Michael G. Vitale. 2012. “Psychological Dysfunction in Children Who Require Repetitive Surgery for Early Onset Scoliosis”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0b013e31826028ea.
- James, J. I. P.. 1954. “Idiopathic Scoliosis”. The Journal of Bone and Joint Surgery. British Volume. British Editorial Society of Bone & Joint Surgery. doi:10.1302/0301-620x.36b1.36.
- Akbarnia, Behrooz A., Lee M. Breakwell, David S. Marks, Richard E. McCarthy, Alistair G. Thompson, Sarah K. Canale, Patricia N. Kostial, Anant Tambe, and Marc A. Asher. 2008. “Dual Growing Rod Technique Followed for Three to Eleven Years Until Final Fusion”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0b013e31816c8b4e.
- Corona, Jacqueline, Daniel J Miller, Jenny Downs, Behrooz A Akbarnia, Randal R Betz, Laurel C Blakemore, Robert M Campbell Jr., et al.. 2013. “Evaluating the Extent of Clinical Uncertainty Among Treatment Options for Patients with Early-onset Scoliosis”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.k.00805.
- Goldberg, C. J., I. Gillic, O. Connaughton, DP Moore, E. E. Fogarty, G. J. Canny, and F. E. Dowling. 2003. “Respiratory Function and Cosmesis at Maturity in Infantile-onset Scoliosis”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.brs.0000085367.24266.ca.
- Thompson, George H., Behrooz A. Akbarnia, and Robert M. Campbell. 2007. “Growing Rod Techniques in Early-onset Scoliosis”. Journal of Pediatric Orthopaedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/bpo.0b013e3180333eea.
- Bess, Shay, Behrooz A Akbarnia, George H Thompson, Paul D Sponseller, Suken A Shah, Hazem El Sebaie, Oheneba Boachie-Adjei, et al.. 2010. “Complications of Growing-rod Treatment for Early-onset Scoliosis”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.i.01471.
- Feinberg, Nicholas, Hiroko Matsumoto, Chun Wai Hung, Tricia St. Hilaire, Jeff Pawelek, Jeffrey R. Sawyer, Behrooz A. Akbarnia, et al.. 2018. “Expert Consensus and Equipoise: Planning a Randomized Controlled Trial of Magnetically Controlled Growing Rods”. Spine Deformity. Springer Science and Business Media LLC. doi:10.1016/j.jspd.2017.11.002.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2019. "Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04058561.
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