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RecruitingNCT05910060OTTAWAKIDSUpdated Jun 18, 2023

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

An observational study in Sports Injuries in Children, sponsored by Central Hospital, Nancy, France. Recruiting at 1 site in France. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-06-18.

Sponsored by Central Hospital, Nancy, France · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
600
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Sports Injuries in Children

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Keywords

  • ankle children Ottawa
03

In context

Athletic Injuries

258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.

This study's planned enrollment of 600 is above the median of 100 across 91 observational studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testOTTAWA ANKLE RULES

    count the ottawa score and do an x-ray if the score is greater than or equal to 1

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 4 month

07

Study locations

1 of 1 sites recruiting
  • children hospital Nancy
    Vandoeuvre Les Nancy, Meurthe-et-Moselle 54500, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05910060
Responsible party
GATIN Amélie (Pediatrician, Central Hospital, Nancy, France) — Principal investigator
First posted
Jun 18, 2023
Start date
May 31, 2023
Primary completion
Oct 31, 2023 (estimated)
Completion
Feb 2024 (estimated)
Last update
Jun 18, 2023

Study contacts

Amélie GATIN
Contact
a.gatin@chru-nancy.fr
0383154727
Anne BORSA DORION
Contact
a.borsa-dorion@chru-nancy.fr
0383154727
Amélie GATIN, MD
principal investigator · Central Hospital, Nancy, France
Ethan JEOL
principal investigator · Central Hospital, Nancy, France

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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