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

NCT ID: NCT05910060

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-02-29

Brief Summary

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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

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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

Conditions

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Sports Injuries in Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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before protocol

patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, before protocol implementation.

No interventions assigned to this group

after protocol

patients between 5 and 18 years of age consulting the paediatric emergency department for ankle trauma, after the implementation of the protocol

OTTAWA ANKLE RULES

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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OTTAWA ANKLE RULES

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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GATIN Amélie

Pediatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amélie GATIN, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Ethan JEOL

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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children hospital Nancy

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Amélie GATIN

Role: CONTACT

0383154727

Anne BORSA DORION

Role: CONTACT

0383154727

Facility Contacts

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Amélie GATIN

Role: primary

0383154727

Anne BORSA DORION

Role: backup

0383154727

Other Identifiers

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2022PI174

Identifier Type: -

Identifier Source: org_study_id

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