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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05910060
Other study ID # 2022PI174
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date February 2024

Study information

Verified date June 2023
Source Central Hospital, Nancy, France
Contact Amélie GATIN
Phone 0383154727
Email a.gatin@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date February 2024
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
OTTAWA ANKLE RULES
count the ottawa score and do an x-ray if the score is greater than or equal to 1

Locations

Country Name City State
France children hospital Nancy Vandoeuvre Les Nancy Meurthe-et-Moselle

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary COMPARISON of the rate of x-rays 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 4 month
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