NCT07046793已完成不适用
Fracture Ultrasound in Kids Wirst Trial (FRUSKI-Wrist)
David Troxler1 个研究点 分布在 1 个国家目标入组 815 人开始时间: 2022年5月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 815
- 试验地点
- 1
- 主要终点
- Possible unstable fracture as final diagnosis
研究概览
简要总结
This is a multicenter combined diagnostic accuracy study and observational prospective cohort.
Part one aims to confirm non-inferiority of POCUS for the detection of distal forearm fractures compared to X-ray.
Part two aims to confirm non-inforiority of POCUS compared to x-ray for the detection of potentially unstable forearm fractures needing follow up imaging.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the emergency room of a study hospital with an acute trauma to the wrist and suspected fracture of the wrist consulted by a trained study examiner.
- •Age 0-18 years Depending on the result
排除标准
- •Patient needing immediate medical attention (triage score 1 or 2) as well as severely displaced or open fractures or neurovascular compromise distally to the suspected fracture.
- •Patient with imaging studies obtained prior to the emergency room visit
- •Patient with prior fracture of the affected wrist within the last 24 months
- •Patient refusing participation / missing informed consent.
结局指标
主要结局
Possible unstable fracture as final diagnosis
时间窗: 4 weeks from inclusion
Fracture yes/no as final diagnosis
时间窗: at 4 weeks from inclusion
次要结局
未报告次要终点
研究者
David Troxler
Sponsor Investigator
University Children's Hospital Basel
研究点 (1)
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