Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-06 @ 2:32 AM
Study NCT ID:
NCT04058561
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-24
First Post:
2019-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Radiographs will be uploaded by each site to the coordinating team and will not have access to the information on exposure arms.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sites will be randomized into two arms of lengthening intervals: 6 weeks (+/- 2 weeks) or 16 weeks (+/- 2 weeks).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal growth', 'timeFrame': '3 years', 'description': 'T1-S1 growth'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '3 years', 'description': 'Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other'}, {'measure': 'Curve correction', 'timeFrame': '3 years', 'description': 'Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years'}, {'measure': 'Health related quality of life: questionnaire', 'timeFrame': '3 years', '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.'}, {'measure': 'Burden of care', 'timeFrame': '3 years', '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Spinal deformity, early onset scoliosis'], 'conditions': ['Early-Onset Scoliosis Deformity of Spine']}, 'referencesModule': {'references': [{'pmid': '23677368', 'type': 'BACKGROUND', 'citation': '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': '22892621', 'type': 'BACKGROUND', 'citation': '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': '13130619', 'type': 'BACKGROUND', 'citation': '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': '1411763', 'type': 'BACKGROUND', 'citation': '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': '17945134', 'type': 'BACKGROUND', 'citation': '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': '22520264', 'type': 'BACKGROUND', 'citation': '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': '14560091', 'type': 'BACKGROUND', 'citation': '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': '17414025', 'type': 'BACKGROUND', 'citation': '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': '20889912', 'type': 'BACKGROUND', 'citation': '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': '15500489', 'type': 'BACKGROUND', 'citation': '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': '8953995', 'type': 'BACKGROUND', 'citation': "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': '18427320', 'type': 'BACKGROUND', 'citation': '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': '29735141', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)\n* Between 5 and 9 years of age (5.0 to 9.9 years)\n* Major curve greater than 50 degrees at time of index surgery\n* Dual-rod Magnetically Controlled Growing Rod implantation only\n* Spine or rib-based constructs\n* Pre-operative and intra-operative halo gravity traction is allowed\n\nExclusion Criteria:\n\n* Patients with previous spine surgery, including other growth friendly techniques\n* Patients who cannot abide by the study requirements due to geographical or other similar constraints'}, 'identificationModule': {'nctId': 'NCT04058561', 'acronym': 'MCGR', 'briefTitle': 'Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals', 'organization': {'class': 'OTHER', 'fullName': 'Pediatric Spine Foundation'}, 'officialTitle': 'Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals', 'orgStudyIdInfo': {'id': 'PSSG0038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6 weeks', 'description': '6-week lengthening interval', 'interventionNames': ['Device: MAGEC® Spinal Bracing And Distraction System']}, {'type': 'ACTIVE_COMPARATOR', 'label': '16 weeks', 'description': '16-week lengthening interval', 'interventionNames': ['Device: MAGEC® Spinal Bracing And Distraction System']}], 'interventions': [{'name': 'MAGEC® Spinal Bracing And Distraction System', 'type': 'DEVICE', '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.', 'armGroupLabels': ['16 weeks', '6 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I. DuPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Health System", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109-4241', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hospital, University of Michigan", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Washington University School of Medicine, St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shriners Hospitals for Children - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Campbell Clinic/Le Bonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75219', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Scottish Rite Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital, Department of Pediatric Orthopaedic Surgery', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong, Department of Orthopaedics and Traumatology', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Michael Vitale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Kenneth MC Cheung, MD, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pediatric Spine Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}