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

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.

Study Overview

• Status: Recruiting
• Conditions: Sports Injuries in Children
• Intervention / Treatment: Diagnostic test: OTTAWA ANKLE RULES

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

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Amélie GATIN; Phone Number: 0383154727; Email: a.gatin@chru-nancy.fr
• Study Contact Backup: Name: Anne BORSA DORION; Phone Number: 0383154727; Email: a.borsa-dorion@chru-nancy.fr

Study Locations

• France
  • Meurthe-et-Moselle
    • Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54500
      • Recruiting
      • children hospital Nancy
      • Contact: Amélie GATIN; Phone Number: 0383154727; Email: a.gatin@chru-nancy.fr
      • Contact: Anne BORSA DORION; Phone Number: 0383154727; Email: a.borsa-dorion@chru-nancy.fr
      • Sub-Investigator: Ethan JEOL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
before protocol; patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, before protocol implementation.
after protocol; patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, after the implementation of the protocol	Diagnostic test: OTTAWA ANKLE RULES; count the ottawa score and do an x-ray if the score is greater than or equal to 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Amélie GATIN, MD, Central Hospital, Nancy, France; Principal Investigator: Ethan JEOL, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: ankle children Ottawa
• Additional Relevant MeSH Terms: Wounds and Injuries; Athletic Injuries
• Other Study ID Numbers: 2022PI174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No