基于医院的集群试验：使用分心间隔的磁控生长杆 (MCGR)
基于医院的集群分层随机控制试验：使用分散间隔确定最佳磁控生长棒实施策略
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Nova Scotia
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Halifax、Nova Scotia、加拿大、B3K 6R8
- IWK Health Centre
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California
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Los Angeles、California、美国、90027
- Children's Hospital Los Angeles
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San Diego、California、美国、92123
- Rady Children's Hospital - San Diego
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Colorado
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Aurora、Colorado、美国、80045
- Children's Hospital Colorado
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Delaware
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Wilmington、Delaware、美国、19803
- Alfred I. DuPont Hospital for Children
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District of Columbia
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Washington D.C.、District of Columbia、美国、20010
- Children's National Health System
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Florida
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Gainesville、Florida、美国、32611
- University of Florida
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Georgia
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Atlanta、Georgia、美国、30342
- Children's Physican Group Orthopaedics/Children's Healthcare of Atlanta
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Maryland
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Baltimore、Maryland、美国、21287
- Johns Hopkins University
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Michigan
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Ann Arbor、Michigan、美国、48109-4241
- C.S. Mott Children's Hospital, University of Michigan
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Missouri
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St Louis、Missouri、美国、63110
- Washington University School of Medicine, St. Louis Children's Hospital
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New York
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New York、New York、美国、10032
- Columbia University Medical Center
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Ohio
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Cleveland、Ohio、美国、44106
- Rainbow Babies and Children's Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- The Children's Hospital of Philadelphia
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Philadelphia、Pennsylvania、美国、19140
- Shriners Hospitals for Children - Philadelphia
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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Tennessee
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Memphis、Tennessee、美国、38104
- Campbell Clinic/Le Bonheur Children's Hospital
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Texas
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Dallas、Texas、美国、75219
- Texas Scottish Rite Hospital
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Turku、芬兰、20521
- Turku University Hospital, Department of Pediatric Orthopaedic Surgery
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Hong Kong、香港
- The University of Hong Kong, Department of Orthopaedics and Traumatology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
- Patients who cannot abide by the study requirements due to geographical or other similar constraints
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：6 weeks
6-week lengthening interval |
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. |
|
有源比较器：16 weeks
16-week lengthening interval |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Spinal growth
大体时间：3 years
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T1-S1 growth |
3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Complications
大体时间：3 years
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Wound related, implant related, intraoperative complications, pseudoarthrosis, neurologic injury/impairment, pulmonary, pain, non-surgical, other |
3 years
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Curve correction
大体时间：3 years
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Change in magnitude of coronal spinal curvature from pre-op to post-op at 3 years |
3 years
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Health related quality of life: questionnaire
大体时间：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. |
3 years
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Burden of care
大体时间：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. |
3 years
|
合作者和调查者
调查人员
- 首席研究员：Michael Vitale, MD、Columbia University
- 首席研究员：Kenneth MC Cheung, MD, FRCS、The University of Hong Kong
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- PSSG0038
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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