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Clinical Trials/NCT05910060
NCT05910060
Recruiting
Not Applicable

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

Central Hospital, Nancy, France1 site in 1 country600 target enrollmentMay 31, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sports Injuries in Children
Sponsor
Central Hospital, Nancy, France
Enrollment
600
Locations
1
Primary Endpoint
COMPARISON of the rate of x-rays
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 31, 2023
End Date
February 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

GATIN Amélie

Pediatrician

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

COMPARISON of the rate of x-rays

Time Frame: 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

Study Sites (1)

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