NCT05910060

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sports Injuries in Children

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OTTAWA ANKLE RULES	count the ottawa score and do an x-ray if the score is greater than or equal to 1

Timeline

• Start date: 2023-05-31
• Primary completion: 2023-10-31
• Completion: 2024-02-01
• First posted: 2023-06-18
• Last updated: 2023-06-18

Locations

1 site across 1 country: France