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临床试验/NCT05910060
NCT05910060招募中不适用

Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
COMPARISON of the rate of x-rays

研究概览

简要总结

Ankle sprain in children is a very common pathology. Currently in France, a standard X-ray is done in almost all cases. However, the literature has for several years validated the consideration of the Ottawa ankle rules in children to avoid the realization of these X-rays.

Our study is an evaluation of clinical practice. The aim is to assess the impact of the implementation of a new protocol using the Ottawa ankle rules from the age of 5. In particular, radiographic sparing and absence of diagnostic error.

详细描述

Main objective: To compare the rate of X-rays performed before and after implementation of the protocol in pediatric emergencies.

Secondary objectives (if applicable):

  • Compare the time spent in the emergency room of patients before and after implementation of the protocol
  • Evaluate the gain in terms of cost for the healthcare system
  • Evaluate the adherence of caregivers to compliance with the protocol
  • Evaluate the decrease in the rate of X-rays performed in different age groups.
  • Evaluation of the consultation rate in the month for the same reason

Primary endpoint = X-ray rate as a % of X-rays performed on the number of children presenting to pediatric emergencies over the period studied (before implementation of the protocol in a similar period = May to October 2022 / after implementation of the protocol = May to October 2023) Secondary endpoints =

  • Time spent in the emergency room in min
  • Estimation of the cost for the healthcare system by taking the cost of an x-ray and evaluating the gain on the reduction in the rate of x-rays performed (number of x-rays - cost of an x-ray)
  • Evaluation of caregiver compliance by measuring the number of X-rays performed outside the protocol (X-ray performed despite the absence of Ottawa criteria)
  • X-ray rate by age group
  • Spontaneous reconsultation rate within 1 month

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

入选标准

  • 5 to 18 years old
  • consulting in pediatric emergency in Nancy children hospital
  • for ankle injury

排除标准

  • Constitutional bone disease Polytrauma Inability to assess the patient (inebriated, altered consciousness, neurosensitive disease, intoxication) Non-acquired walking Injury more than 10 days old Patient re-consults for the same injury previously assessed in the same centre Patient with previous radiographs prior to consultation Open fracture Sensory or vascular deficit Haemophilia Metabolic disease with proven osteopenia

结局指标

主要结局

COMPARISON of the rate of x-rays

时间窗: 4 month

COMPARISON of the rate of x-rays as a % of x-rays performed among the number of children presenting to paediatric emergency departments over the period studied before and after implementation of the protoc

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

GATIN Amélie

Pediatrician

Central Hospital, Nancy, France

研究点 (1)

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