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

Study Overview
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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)

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

Conditions
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Ankle Trauma

Intervention / Treatment
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* Radiation: ankle ultrasound
* Radiation: Member MRI


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ankle ultrasound & ankle MRI<br>Ankle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma | Radiation: ankle ultrasound<br>* Ankle ultrasound performed during emergencies visit.<br>Radiation: Member MRI<br>* Member MRI (without injection of contrast product) performed within 7 days following the trauma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance rate of anatomical lesions of the ankle of ultrasound | Sensitivity of ankle ultrasound compared to MRI, considered as a gold standard, in the diagnosis of traumatic ankle injuries | Baseline (inclusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance rate of anatomical lesions | Specificity, predictive values (positive and negative) and likelihood ratios (positive and negative) of ultrasound versus MRI | Baseline (inclusion) and at visit 2 (within 7 days after the baseline) | 
| The use of Ottawa decision rule | the place of Ottawa criteria and ultrasound in the decision algorithm to limit standard radiographs (and thus irradiation). The Ottawa Ankle Rule was derived to aid in the efficient use of radiography in acute ankle and midfoot injuries. | baseline (inclusion) | 
| orthopedic rehabilitation quality at 3 weeks according to the Oxford score. | The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is used to measure subjective well-being for child patients (aged 5-16) affected by foot and ankle conditions using issues that are considered important to children. The OxAFQ-C has 15 items, 14 of which are used to calculate domain scores: Physical (6 items); School and Play (4 items) Emotional (4 items) | at 3 weeks (control visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle, diagnostic, ankle's ultrasound, traumatic lesion