Hospital-Based Cluster Stratified Randomization Control Trial: Determination of Best Magnetically Controlled Growing Rods Implementation Strategy Using Distraction Intervals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
- 试验地点
- 39
- 主要终点
- Spinal growth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Radiographs will be uploaded by each site to the coordinating team and will not have access to the information on exposure arms.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Spinal growth
时间窗: 3 years
T1-S1 growth
次要结局
- Health related quality of life: questionnaire(3 years)
- Curve correction(3 years)
- Complications(3 years)
- Burden of care(3 years)