ANKLE TRAUMA Diagnostic Value of Ultrasound Compared to Standard Radiography in the Detection of Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Negative predictive value
研究概览
简要总结
To investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive Ottawa ankle rules
详细描述
Selection of patients is according to the criteria detailed below. If the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. Besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter.
Care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. Sonographic results will not be used for this purpose. All ankle x-ray series will be reviewed by a senior resident radiologist.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult patient with acute ankle trauma
- •+ one or more criteria of the Ottawa ankle rules :
- •Inability to walk 4 steps immediately after the trauma or in the emergency room,
- •pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone.
排除标准
- •Any patient under the age of 18 years
- •Any patient unable to sign the informed consent
- •Skin lesions contraindicating sonography (e.g. open fracture wound, ... )
- •An unstable patient whose inclusion in the study would delay vital treatment
结局指标
主要结局
Negative predictive value
时间窗: at inclusion
Negative predictive value of ultrasound compared to standard radiography in the detection of long bone fractures
次要结局
- Specificity(at inclusion)
- Sensitivity(at inclusion)