Clinical trial NCT05910060: Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
Official title: Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sports Injuries in Children
Keywords: ankle children Ottawa
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5 to 18 years old consulting in pediatric emergency in Nancy children hospital for ankle injury

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

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

Primary outcomes:
measure: COMPARISON of the rate of x-rays
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: children hospital Nancy
state: Meurthe-et-Moselle
Study officials:
affiliation: Central Hospital, Nancy, France
name: Amélie GATIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Hospital, Nancy, France
name: Ethan JEOL
role: PRINCIPAL_INVESTIGATOR
References: