Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Reliability and agreement in Alpha/Beta angles, Femoral head coverage and Pubo-femoral distance
研究概览
简要总结
Several measurements are used to evaluate hip dysplasia in hip ultrasound of children. Despite having being used since the 1980s, reliability studies have failed to find acceptable reliaiblity values for the gold standard ultrasound methods.
This study will evaluate three ultrasound measurement methodologies in a high quality controlled setting, to investigate the best achieveable reliability and agreement of the investigated measurements used in hip dysplasia diagnostics.
详细描述
In DDH diagnostics, measurements of acetabular alpha angles and femoral head coverages (FHC), developed by Graf and Harcke/Terjesen respectively, have been gold standard since the 1980s. Despite their widespread use, the reliability of these measurements has been questioned due to the relative complexity of acquiring the necessary corIDrect frontal 2D plane or "standard plane". In the only meta-analysis of the reliability of ultrasound (US) metrics in dysplasia, the interrater reliability of the alpha angles was mediocre while the reliability of the FHC was poor. Critics of these findings however argue that the low reliability reported in studies are due to misinterpretation and misapplication of the Graf method.
The pubo-femoral distance (PFD) was proposed in 2013 as a new measurement for assessing DDH, while the reliability is reportedly higher than the gold standard US methods, it has never been directly compared to these.
This study aims to evaluate the inter- and intrarater reliability of Graf's alpha and beta angles, the FHC and PFD in children referred for hip US in a selective ultrasound screening program for DDH.
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
盲法说明
The radiologist will be blinded to each others measurements, until all examinations have been performed.
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.
- •Children receiving follow-up ultrasound for previously diagnosed DDH
排除标准
- •Children deemed too agitated to participate in hip US with double measurements by two radiologists.
研究组 & 干预措施
Double measurements
All included children will have double measurements of the investigated ultrasound methodologies performed by two separate musculoskeletal radiologists.
干预措施: Repeat hip ultrasound measurements (Diagnostic Test)
结局指标
主要结局
Reliability and agreement in Alpha/Beta angles, Femoral head coverage and Pubo-femoral distance
时间窗: Ultrasound measurements collected during the ultrasound examination by both radiologists
For all included ultrasound measurement methods the following will be reported: Inter- and intrarater reliability will be evaluated using the intraclass correlation coefficient (ICC) and interpreted with ICC values between 0-0.5, 0.5-0.75, 0.75-0.9 and above 0.9 indicating poor, moderate, good and excellent reliability respectively. Agreement will be evaluated using Bland-Altman plots (to check for systematic bias) and mean absolute measurement differences between raters.
次要结局
未报告次要终点
研究者
Hans-Christen Husum
Postdoctoral Research Fellow, Department of Radiology, Principal Investigator
Aarhus University Hospital