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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)
This study is currently recruiting participants.
Study NCT00639028   Information provided by University Hospital, Grenoble
First Received: March 11, 2008   Last Updated: September 2, 2009   History of Changes

March 11, 2008
September 2, 2009
October 2007
September 2010   (final data collection date for primary outcome measure)
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT) [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639028 on ClinicalTrials.gov Archive Site
  • Lower Extremity Functional Squale (LEFS) Score [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
  • Lower Extremity Functional Squale (LEFS) Score [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
  • Baecke Physical Activity Questionnaire Score [ Time Frame: at the clinical examination ] [ Designated as safety issue: No ]
  • Cumberland Ankle Instability Tool (CAIT) Score [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
  • Number of lesions in the group echography/stress radiography versus in the group echography. [ Time Frame: at the clinical examination ] [ Designated as safety issue: Yes ]
Same as current
 
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.

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.

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.

 
Interventional
Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment
Lateral Ankle Sprain
  • Other: Ankle echography
  • Other: Ankle echography + stress radiography
  • Other: stress radiography
  • Other: Ankle echography
  • Other: echography + stress radiography
  • Other: stress radiography

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
390
November 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact: Jean-Luc Cracowski, MD 0033476769260 JLCracowski@chu-grenoble.fr
France
 
NCT00639028
M. Eric Svahn, Direction de la Recherche Clinique, CHU de Grenoble, 38043 Grenoble Cedex 09
DCIC 07 02
University Hospital, Grenoble
 
Principal Investigator: Jean-Jacques Banihachemi University Hospital, Grenoble
University Hospital, Grenoble
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP