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Completed

NCT Number: NCT00639028

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

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency department - University Hospital of Grenoble South

Grenoble, 38100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ankle echography

Other

Ankle echography

Ankle echography + stress radiography

Other

Ankle echography + stress radiography

stress radiography

Other

ankle stress radiography

Primary outcomes

  1. Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)

    Time frame: at one year

Secondary outcomes

  1. Lower Extremity Functional Squale (LEFS) Score

    Time frame: at one year

  2. Lower Extremity Functional Squale (LEFS) Score

    Time frame: at two years

  3. Baecke Physical Activity Questionnaire Score

    Time frame: at the clinical examination

  4. Cumberland Ankle Instability Tool (CAIT) Score

    Time frame: at two years

  5. Number of lesions in the group echography/stress radiography versus in the group echography.

    Time frame: at the clinical examination

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: TALOS

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Mar 19, 2008
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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