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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05910060
Collaborator
(none)
600
1
8.1
74.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact
Actual Study Start Date :
May 31, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. COMPARISON of the rate of x-rays [4 month]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 children hospital Nancy Vandoeuvre Les Nancy Meurthe-et-Moselle France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GATIN Amélie, Pediatrician, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05910060
Other Study ID Numbers:
  • 2022PI174
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GATIN Amélie, Pediatrician, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2023