Evaluation of the Benefits of Ultrasound in Improving the Diagnosis and Management of Injuries the Child's Ankle

NCT ID: NCT03507972

Last Updated: 2025-12-08

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

TERMINATED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-25

Study Completion Date

2020-01-31

Brief Summary

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Evaluate ankle's ultrasound contribution in the accuracy of ankle's diagnosis of traumatic injuries (objectivated by reference's examination : ankle's MRI)

Detailed Description

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Conditions

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Ankle Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ankle ultrasound & ankle MRI

Ankle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma

Group Type OTHER

ankle ultrasound

Intervention Type RADIATION

Ankle ultrasound performed during emergencies visit.

Member MRI

Intervention Type RADIATION

Member MRI (without injection of contrast product) performed within 7 days following the trauma

Interventions

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ankle ultrasound

Ankle ultrasound performed during emergencies visit.

Intervention Type RADIATION

Member MRI

Member MRI (without injection of contrast product) performed within 7 days following the trauma

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 5 years and \< 18 years
* Isolated's trauma from one or both ankles
* First-line consultation for pediatrics emergencies at the University Hospital of Lille
* Informed and written consent of the holders of parental authority

Exclusion Criteria

* Age \< 5 years and ≥ 18 years
* History of trauma of the same ankle dating from less than 3 month
* History of surgery of this same ankle
* Constitutional or acquired bone disease
* Associated trauma affecting another anatomical region than the ankle or midfoot
* Polytrauma (presence of several traumas including at least one endangers vital functions)
* Associated wound requiring surgical exploration
* initial management of this trauma in another center
* Non affiliation to a social security scheme
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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François Dubos, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Unité de pédiatrie Générale, Urgences et Maladies Infectieuses, Pôle de l'Urgence, Hôpital Roger Salengro

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2015-A01127-42

Identifier Type: OTHER

Identifier Source: secondary_id

2014_35

Identifier Type: -

Identifier Source: org_study_id

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