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

NCT04058561 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PSSG0038
• Study Type: interventional
• Target: 210
• Locations: 4 countries
• Sites: 20

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.

Conditions

Early-Onset Scoliosis Deformity of Spine

Keywords

Spinal deformity, early onset scoliosis

Outcome Measures

Primary Outcomes (1)

• Spinal growth

  T1-S1 growth

  3 years

Secondary Outcomes (4)

• Complications

  3 years

• Curve correction

  3 years

• Health related quality of life: questionnaire

  3 years

• Burden of care

  3 years

Study Arms (2)

6 weeks

EXPERIMENTAL

6-week lengthening interval

Device: MAGEC® Spinal Bracing And Distraction System

16 weeks

ACTIVE COMPARATOR

16-week lengthening interval

Device: MAGEC® Spinal Bracing And Distraction System

Interventions

MAGEC® Spinal Bracing And Distraction System DEVICE

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; 6 weeks

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatric Spine Foundation: lead
• Columbia University: collaborator

Study Sites (20)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Rady Children's Hospital - San Diego

San Diego, California, 92123, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

C.S. Mott Children's Hospital, University of Michigan

Ann Arbor, Michigan, 48109-4241, United States

Location

Washington University School of Medicine, St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Shriners Hospitals for Children - Philadelphia

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Campbell Clinic/Le Bonheur Children's Hospital

Memphis, Tennessee, 38104, United States

Location

Texas Scottish Rite Hospital

Dallas, Texas, 75219, United States

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Turku University Hospital, Department of Pediatric Orthopaedic Surgery

Turku, 20521, Finland

Location

The University of Hong Kong, Department of Orthopaedics and Traumatology

Hong Kong, Hong Kong

Location

Related Publications (13)

• 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.

  PMID: 23677368 BACKGROUND

• 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.

  PMID: 22892621 BACKGROUND

• 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.

  PMID: 13130619 BACKGROUND

• 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.

  PMID: 1411763 BACKGROUND

• 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.

  PMID: 17945134 BACKGROUND

• 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.

  PMID: 22520264 BACKGROUND

• 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.

  PMID: 14560091 BACKGROUND

• 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.

  PMID: 17414025 BACKGROUND

• 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.

  PMID: 20889912 BACKGROUND

• 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.

  PMID: 15500489 BACKGROUND

• 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.

  PMID: 8953995 BACKGROUND

• 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.

  PMID: 18427320 BACKGROUND

• 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.

  PMID: 29735141 BACKGROUND

Study Officials

• Michael Vitale, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Kenneth MC Cheung, MD, FRCS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Radiographs will be uploaded by each site to the coordinating team and will not have access to the information on exposure arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: November 1, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1); HK (1); CA (1); US (17)