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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Lateral Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Ankle echography

Group Type OTHER

Ankle echography

Intervention Type OTHER

Ankle echography

2

echography + stress radiography

Group Type OTHER

Ankle echography + stress radiography

Intervention Type OTHER

Ankle echography + stress radiography

3

stress radiography

Group Type OTHER

stress radiography

Intervention Type OTHER

ankle stress radiography

Interventions

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Ankle echography

Intervention Type OTHER

Ankle echography + stress radiography

Intervention Type OTHER

stress radiography

ankle stress radiography

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No