Clinical trial NCT00639028: Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)
Official title: Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Ankle Sprain
Keywords: ankle
diagnosis
sprain
care
injury
stress radiography
ultrasonography
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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 criteria: 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.

Primary outcomes:
measure: Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
timeFrame: at one year
Secondary outcomes:
measure: Lower Extremity Functional Squale (LEFS) Score
timeFrame: at one year
measure: Lower Extremity Functional Squale (LEFS) Score
timeFrame: at two years
measure: Baecke Physical Activity Questionnaire Score
timeFrame: at the clinical examination
measure: Cumberland Ankle Instability Tool (CAIT) Score
timeFrame: at two years
measure: Number of lesions in the group echography/stress radiography versus in the group echography.
timeFrame: at the clinical examination
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Emergency department - University Hospital of Grenoble South
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Jacques Banihachemi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Picard F, Tourne Y, Montbarbon E, Saragaglia D. [Ankle trauma. Diagnostic orientation]. Rev Prat. 1995 Nov 15;45(18):2335-42. No abstract available. French.
citation: Braun BL. Effects of ankle sprain in a general clinic population 6 to 18 months after medical evaluation. Arch Fam Med. 1999 Mar-Apr;8(2):143-8. doi: 10.1001/archfami.8.2.143.
citation: Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.
citation: Raatikainen T, Putkonen M, Puranen J. Arthrography, clinical examination, and stress radiograph in the diagnosis of acute injury to the lateral ligaments of the ankle. Am J Sports Med. 1992 Jan-Feb;20(1):2-6. doi: 10.1177/036354659202000102.
citation: Brasseur JL, Morvan G, Godoc B. [Dynamic ultrasonography]. J Radiol. 2005 Dec;86(12 Pt 2):1904-10. doi: 10.1016/s0221-0363(05)81544-6. French.
citation: Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41. doi: 10.1016/j.apmr.2006.05.022.