Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS) (TALOS)
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|ClinicalTrials.gov Identifier: NCT00639028|
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lateral Ankle Sprain||Other: Ankle echography Other: Ankle echography + stress radiography Other: stress radiography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
Other: Ankle echography
echography + stress radiography
Other: Ankle echography + stress radiography
Ankle echography + stress radiography
Other: stress radiography
ankle stress radiography
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639028
|Emergency department - University Hospital of Grenoble South|
|Grenoble, France, 38100|
|Principal Investigator:||Jean-Jacques Banihachemi||University Hospital, Grenoble|