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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) (TALOS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639028
First Posted: March 19, 2008
Last Update Posted: January 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
March 11, 2008
March 19, 2008
January 23, 2014
November 2007
December 2013   (Final data collection date for primary outcome measure)
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT) [ Time Frame: at one year ]
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 ]
  • Lower Extremity Functional Squale (LEFS) Score [ Time Frame: at two years ]
  • Baecke Physical Activity Questionnaire Score [ Time Frame: at the clinical examination ]
  • Cumberland Ankle Instability Tool (CAIT) Score [ Time Frame: at two years ]
  • Number of lesions in the group echography/stress radiography versus in the group echography. [ Time Frame: at the clinical examination ]
Same as current
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Lateral Ankle Sprain
  • Other: Ankle echography
    Ankle echography
  • Other: Ankle echography + stress radiography
    Ankle echography + stress radiography
  • Other: stress radiography
    ankle stress radiography
  • 1
    Ankle echography
    Intervention: Other: Ankle echography
  • 2
    echography + stress radiography
    Intervention: Other: Ankle echography + stress radiography
  • 3
    stress radiography
    Intervention: Other: stress radiography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
January 2014
December 2013   (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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00639028
DCIC 07 02
Yes
Not Provided
Not Provided
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-Jacques Banihachemi University Hospital, Grenoble
University Hospital, Grenoble
January 2014

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