NCT03507972终止不适用
Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of the Child's Traumatic Ankle Injuries
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2016年2月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Diagnostic performance rate of anatomical lesions of the ankle of ultrasound
研究概览
简要总结
Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 5 years and < 18 years
- •Isolated's trauma from one or both ankles
- •First-line consultation for pediatrics emergencies at the University Hospital of Lille
- •Informed and written consent of the holders of parental authority
排除标准
- •Age < 5 years and ≥ 18 years
- •History of trauma of the same ankle dating from less than 3 month
- •History of surgery of this same ankle
- •Constitutional or acquired bone disease
- •Associated trauma affecting another anatomical region than the ankle or midfoot
- •Polytrauma (presence of several traumas including at least one endangers vital functions)
- •Associated wound requiring surgical exploration
- •initial management of this trauma in another center
- •Non affiliation to a social security scheme
结局指标
主要结局
Diagnostic performance rate of anatomical lesions of the ankle of ultrasound
时间窗: Baseline (inclusion)
Sensitivity of ankle ultrasound compared to MRI, considered as a gold standard, in the diagnosis of traumatic ankle injuries
次要结局
- The use of Ottawa decision rule(baseline (inclusion))
- orthopedic rehabilitation quality at 3 weeks according to the Oxford score.(at 3 weeks (control visit))
- Diagnostic performance rate of anatomical lesions(Baseline (inclusion) and at visit 2 (within 7 days after the baseline))
研究者
研究点 (2)
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