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

NCT03507972 | Terminated

• 2 other identifiers: 2014_352015-A01127-42
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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)

Conditions

Ankle Trauma

Keywords

ankle; diagnostic; ankle's ultrasound; traumatic lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic performance rate of anatomical lesions

  Baseline (inclusion) and at visit 2 (within 7 days after the baseline)

• The use of Ottawa decision rule

  baseline (inclusion)

• orthopedic rehabilitation quality at 3 weeks according to the Oxford score.

  at 3 weeks (control visit)

Study Arms (1)

Ankle ultrasound & ankle MRI

OTHER

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; Radiation: Member MRI

Interventions

ankle ultrasound RADIATION

Ankle ultrasound performed during emergencies visit.

Ankle ultrasound & ankle MRI

Member MRI RADIATION

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

Ankle ultrasound & ankle MRI

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

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

Lille, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Dubos, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: April 25, 2018
• Study Start: February 25, 2016
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)