Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 1
- 主要终点
- ultrasound-based Referral Status
研究概览
简要总结
In the scoliosis screening program of the Student Health Service (SHS), Department of Health (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have Cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. Our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with Cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the accuracy of ultrasound assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Schoolchildren in Hong Kong attending School Screening Program provided by Student Health Service ii. Recommended for radiographic assessment in the scoliosis screening program
排除标准
- •i. Patients with standing height <1 m, or >2 m ii. Patients with body mass index (BMI) ≥25 kg/m2 iii. Subjects with skin diseases iv. Subjects with fracture or wound that affect ultrasound scanning v. Subjects with ferromagnetic implants vi. Subjects with surgery done for the spine vii. Subjects with winged scapula or other irregularity of back contour that affect ultrasound scanning viii. Subjects who cannot stand steadily during scanning ix. Subjects with allergy to ultrasound gel
结局指标
主要结局
ultrasound-based Referral Status
时间窗: Baseline
"for specialist referral" or "not for specialist referral", through predicting whether the Cobb angle is beyond the referral threshold of ≥20° or not in scoliosis screening
次要结局
- ATR(Baseline)
研究者
Tsz-ping Lam
Assistant Professor
Chinese University of Hong Kong