Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS) (TALOS)
|Lateral Ankle Sprain||Other: Ankle echography Other: Ankle echography + stress radiography Other: stress radiography|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.|
- Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT) [ Time Frame: at one year ]
- 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 ]
|Study Start Date:||November 2007|
|Study Completion Date:||January 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Other: Ankle echography
echography + stress radiography
Other: Ankle echography + stress radiography
Ankle echography + stress radiography
Other: stress radiography
ankle stress radiography
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639028
|Emergency department - University Hospital of Grenoble South|
|Grenoble, France, 38100|
|Principal Investigator:||Jean-Jacques Banihachemi||University Hospital, Grenoble|