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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00639028
Acronym
TALOS
Enrollment
390
Registered
2008-03-19
Start date
2007-11-30
Completion date
2014-01-31
Last updated
2014-01-23

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

Conditions

Lateral Ankle Sprain

Keywords

ankle, diagnosis, sprain, care, injury, stress radiography, ultrasonography

Brief summary

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

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.

Interventions

OTHERAnkle echography

Ankle echography

OTHERAnkle echography + stress radiography

Ankle echography + stress radiography

ankle stress radiography

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)at one year

Secondary

MeasureTime frame
Lower Extremity Functional Squale (LEFS) Scoreat one year
Baecke Physical Activity Questionnaire Scoreat the clinical examination
Cumberland Ankle Instability Tool (CAIT) Scoreat two years
Number of lesions in the group echography/stress radiography versus in the group echography.at the clinical examination

Countries

France

Outcome results

None listed

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