Repeatability and Reproducibility of Low-dose Digital Radiographs in the Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Repeatability and reproducibility
研究概览
简要总结
The aim of the study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.
详细描述
The 80% of scoliosis is idiopathic and begins mostly in adolescence (10-20 years).
The young patients need to undergo several radiographic controls for a correct therapeutic balance. However, the repeated radiation exposures is associated with a greater risk of carcinogenesis even if reduced with a digital imaging technique.
The aim of this study is to evaluate the intraobserver repeatability and the interobserver reproducibility of low-dose radiographs with a HELIOS DRF (CAT) imaging system in patients with idiopathic scoliosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with suspected or known idiopathic scoliosis
- •patients able to maintain orthostasis without medical devices
- •patients from 9 to 20 years old
排除标准
- •patients with known congenital, syndromic, neurological scoliosis
- •patients not able to maintain orthostasis
- •obese patients
- •low back pain or known tumor pathology
- •patients with vertebral arthrodesis
- •patients younger than 9 years old, or older than 20 years old
结局指标
主要结局
Repeatability and reproducibility
时间窗: baseline (day 0)
Repeatability and reproducibility of the Cobb angle measurement
次要结局
- Radiation exposure(baseline (day 0))
- Repeatability and reproducibility(baseline (day 0))