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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03507972
Acronym
ANKLE
Enrollment
97
Registered
2018-04-25
Start date
2016-02-25
Completion date
2020-01-31
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Trauma

Keywords

ankle, diagnostic, ankle's ultrasound, traumatic lesion

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)

Interventions

RADIATIONankle ultrasound

Ankle ultrasound performed during emergencies visit.

RADIATIONMember MRI

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance rate of anatomical lesions of the ankle of ultrasoundBaseline (inclusion)Sensitivity of ankle ultrasound compared to MRI, considered as a gold standard, in the diagnosis of traumatic ankle injuries

Secondary

MeasureTime frameDescription
Diagnostic performance rate of anatomical lesionsBaseline (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
The use of Ottawa decision rulebaseline (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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026