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

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

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

Study Overview

• Status: Terminated
• Conditions: Ankle Trauma
• Intervention / Treatment: Radiation: ankle ultrasound; Radiation: Member MRI

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Radiation: ankle ultrasound; Ankle ultrasound performed during emergencies visit.; Radiation: Member MRI; Member MRI (without injection of contrast product) performed within 7 days following the trauma

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: François Dubos, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2016
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ankle; diagnostic; ankle's ultrasound; traumatic lesion
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease
• Other Study ID Numbers: 2014_35; 2015-A01127-42 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No