A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 15
- 主要终点
- Change in Cobb Angle
研究概览
简要总结
The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early onset spinal deformity with any etiology
- •Cobb angle measurement of 30 degrees or greater at the time of primary surgery
- •Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
- •Age less than 11 years old at the time of MAGEC implant
- •Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
- •Patient has been implanted for a minimum of 6 months
- •Patient signs informed consent for the use of their personal private data
排除标准
- •Patient declines to sign informed consent for the use of their personal private data.
结局指标
主要结局
Change in Cobb Angle
时间窗: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in Degrees
Change in Thoracic Spine Height
时间窗: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in millimeters (mm)
Change in Space Available for Lung
时间窗: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured as a percentage (%)
Ocurrence of Procedure-Related Complications
时间窗: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Adverse Events
时间窗: Baseline and 6, 12, 18 and 24 Months Postoperatively
次要结局
- Change in Coronal Balance(Baseline and 6, 12, 18 and 24 Months Postoperatively)
- Change in Sagittal Balance(Baseline and 6, 12, 18 and 24 Months Postoperatively)
- Occurrence of Subsequent surgical interventions following initial implantation(Baseline and 6, 12, 18 and 24 Months Postoperatively)
- Change in Weight(Baseline and 6, 12, 18 and 24 Months Postoperatively)