NCT05910060

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 9, 2023

Last Update Submit

June 16, 2023

Conditions

Keywords

ankle children Ottawa

Outcome Measures

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

    4 month

Study Arms (2)

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

OTTAWA ANKLE RULESDIAGNOSTIC_TEST

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

after protocol

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

children hospital Nancy

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

RECRUITING

Study Officials

  • Amélie GATIN, MD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR
  • Ethan JEOL

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatrician

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 18, 2023

Study Start

May 31, 2023

Primary Completion

October 31, 2023

Study Completion

February 1, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations