Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)

Study Overview
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Brief Summary
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The aim of our study is to determine the most efficient radiologic examination to assess the ankle sprain seriousness and so improve the therapeutic care.

Detailed Description
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The lateral ankle sprain is the most frequent purpose of consultation in emergency traumatology of the locomotive system. If the ankle sprain is neglected or badly cared, it can induce a recurrence or several complications particularly functional ones. So a gravity diagnosis is necessary in order to choose the most accurate treatment. Considering the difficulty of the clinical estimation, additional examinations aim to support the positive diagnosis, to clarify the gravity and to dismiss differential diagnosis. Thus we suggest to evaluate three strategies in order to get a gravity diagnosis, make a better choice of treatment and so decrease the long-term functional complications : instability and recurrence. The patients are randomly separated into three groups of 130 people. All the patients have a radiography and then, according to their group, they have either an ultrasonography or an ultrasonography and a stress radiography or only a stress radiography. The patients are followed up during two years by sending two questionnaires (CAIT and LEFS) at one and two years. The functional scores of these questionnaires assess and compare the functional complications for each group. Thus the radiologic examinations can be assessed in term of prognosis.

Official Title
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Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.

Conditions
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Lateral Ankle Sprain

Intervention / Treatment
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* Other: Ankle echography
* Other: Ankle echography + stress radiography
* Other: stress radiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lateral ankle sprain. Sprain occurred for less than 48 hours. Age between 18 and 55. Person affiliated at the Social Security. Exclusion Criteria: Recurrent lateral ankle sprain occurred for less than 2 years and diagnosed by a doctor. Bilateral sprain, medio-tarsal sprain, syndesmosis sprain, subtalar sprain. Tendinous luxation (fibular, posterior tibial). Homolateral ankle fracture occurred for less than 2 years. Cuboid fracture, external tubercle of astragalus fracture, calcaneum fracture, fracture of the talus extremity, base of the fifth metatarsal bone fracture. Tearing of internal malleolus, tearing of astragalus posterior tubercle. Osteochondral lesions of the astragalus dome. Probable difficulty to follow up the patient. Patient taking anticoagulant. Pregnant woman, parturient, breast-feeding mother. Person deprived of freedom after a judicial or an administrative decision, person with legal protection measure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Ankle echography | Other: Ankle echography<br>* Ankle echography<br>|
| Other: 2<br>echography + stress radiography | Other: Ankle echography + stress radiography<br>* Ankle echography + stress radiography<br>|
| Other: 3<br>stress radiography | Other: stress radiography<br>* ankle stress radiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT) |  | at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Functional Squale (LEFS) Score |  | at one year | 
| Lower Extremity Functional Squale (LEFS) Score |  | at two years | 
| Baecke Physical Activity Questionnaire Score |  | at the clinical examination | 
| Cumberland Ankle Instability Tool (CAIT) Score |  | at two years | 
| Number of lesions in the group echography/stress radiography versus in the group echography. |  | at the clinical examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ankle, diagnosis, sprain, care, injury, stress radiography, ultrasonography