ClinicalTrials.Veeva

Menu

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

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Sports Injuries in Children

Treatments

Diagnostic Test: OTTAWA ANKLE RULES

Study type

Observational

Funder types

Other

Identifiers

NCT05910060
2022PI174

Details and patient eligibility

About

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.

Full 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

Enrollment

600 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

before protocol
Description:
patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, before protocol implementation.
after protocol
Description:
patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, after the implementation of the protocol
Treatment:
Diagnostic Test: OTTAWA ANKLE RULES

Trial contacts and locations

1

Loading...

Central trial contact

Anne BORSA DORION; Amélie GATIN

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems