Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
研究概览
简要总结
The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography.
The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.
详细描述
For usual follow-up visit, patients will have a x-ray examination of the spine and the surface topography. The measurement of the angle of scoliosis is achieved by two independent operators for both methods.
Patients then have a follow-up visit at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with idiopathic scoliosis,
- •Body mass index BMI below or equal to 25,
- •Cobb angle measured on radiographs between 10 and 25 degrees,
- •Parental authorization.
排除标准
- •Patient with secondary scoliosis (neurological, Prader Willi syndrome...)
研究组 & 干预措施
Intervention
The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.
'Use of Biomod device' for all the patient in addition to the conventional X-ray examination.
干预措施: Use of Biomod device (Device)
结局指标
主要结局
Correlation between the measurement of Cobb angle by conventional .radiography and surface topography.
时间窗: up to 1 year
Number of participants with the same cobb angle measured by surface topography and measured by x-ray.
次要结局
- Reproducibility within the operator of measurement of the angle by surface topography(At each visit two successive measurements are made by the operator for the same patient. up to 1 year)
- Reproducibility between the operator of measurement of the angle by surface topography(up to 1 year)
- The sensitivity of the topography on the detection of the deterioration of the Cobb angle(up to 1 year)