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

Not Applicable

• Conditions: Ankle Trauma
• Interventions: Radiation: ankle ultrasound; Radiation: Member MRI

• Registration Number: NCT03507972
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-02-25
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankle ultrasound & ankle MRI	ankle ultrasound	Ankle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma
Ankle ultrasound & ankle MRI	Member MRI	Ankle ultrasound performed on the day of emergency consultation member MRI (without injection of contrast products) performed within 7 days following the trauma

Primary Outcome Measures

Name	Time	Method
Diagnostic performance rate of anatomical lesions of the ankle of ultrasound	Baseline (inclusion)	Sensitivity of ankle ultrasound compared to MRI, considered as a gold standard, in the diagnosis of traumatic ankle injuries

Secondary Outcome Measures

Name	Time	Method
The use of Ottawa decision rule	baseline (inclusion)	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.
orthopedic rehabilitation quality at 3 weeks according to the Oxford score.	at 3 weeks (control visit)	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)
Diagnostic performance rate of anatomical lesions	Baseline (inclusion) and at visit 2 (within 7 days after the baseline)	Specificity, predictive values (positive and negative) and likelihood ratios (positive and negative) of ultrasound versus MRI

Trial Locations

Locations (1)

Unité de pédiatrie Générale, Urgences et Maladies Infectieuses, Pôle de l'Urgence, Hôpital Roger Salengro; 🇫🇷 Lille, France