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| Sponsored by: |
University Hospital, Grenoble |
| Information provided by: | University Hospital, Grenoble |
| ClinicalTrials.gov Identifier: | NCT00639028 |
Purpose
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.
| Condition | Intervention |
|
Lateral Ankle Sprain |
Other: Ankle echography Other: Ankle echography + stress radiography Other: stress radiography |
| MedlinePlus related topics: | Stress Ultrasound X-Rays |
| ChemIDplus related topics: | X-Rays |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment |
| Official Title: | Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains. |
| Estimated Enrollment: | 390 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1
Ankle echography
|
Other: Ankle echography
Ankle echography
|
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2
echography + stress radiography
|
Other: Ankle echography + stress radiography
Ankle echography + stress radiography
|
|
3
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jean-Luc Cracowski, MD | 0033476769260 | JLCracowski@chu-grenoble.fr |
| France | |||||
| Emergency department - University Hospital of Grenoble South | Recruiting | ||||
| Grenoble, France, 38100 | |||||
| Contact: Jean-Jacques Banihachemi 0033476765423 JJBanihachemi@chu-grenoble.fr | |||||
| Sub-Investigator: Christophe Chaussard | |||||
| Sub-Investigator: Jean-Noël Ravey | |||||
| University Hospital, Grenoble |
| Principal Investigator: | Jean-Jacques Banihachemi | University Hospital, Grenoble |
More Information
| Responsible Party: | Direction de la Recherche Clinique, CHU de Grenoble, 38043 Grenoble Cedex 09 ( M. Eric Svahn ) |
| Study ID Numbers: | DCIC 07 02 |
| First Received: | March 11, 2008 |
| Last Updated: | March 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639028 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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