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

Ankle Trauma Clinical Trial

— ANKLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507972
• Other study ID #: 2014_35
• Secondary ID: 2015-A01127-42
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2016
• Est. completion date: August 2021

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: François Dubos, MD
• Email: francois.dubos[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Trauma

Intervention

Radiation:
• ankle ultrasound
Ankle ultrasound performed during emergencies visit.
• Member MRI
Member MRI (without injection of contrast product) performed within 7 days following the trauma

Locations

Country	Name	City	State
France	Unité de pédiatrie Générale, Urgences et Maladies Infectieuses, Pôle de l'Urgence, Hôpital Roger Salengro	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)