Official Title: “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.

Study Type: Interventional

Study Design: Diagnostic, Randomized, Open Label, Uncontrolled, Parallel Assignment

Study Primary Completion Date: September 2010

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.

Intervention(s) in this Clinical Trial

• Other: Ankle echography
  • Ankle echography
• Other: Ankle echography + stress radiography
  • Ankle echography + stress radiography
• Other: stress radiography
  • ankle stress radiography

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Ankle echography
• Other: 2
  • echography + stress radiography
• Other: 3
  • stress radiography

Primary Measures

• Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
  • Time Frame: at one year
    Safety Issue?: Yes

Secondary Measures

• Lower Extremity Functional Squale (LEFS) Score
  • Time Frame: at one year
    Safety Issue?: Yes
• Lower Extremity Functional Squale (LEFS) Score
  • Time Frame: at two years
    Safety Issue?: Yes
• Baecke Physical Activity Questionnaire Score
  • Time Frame: at the clinical examination
    Safety Issue?: No
• Cumberland Ankle Instability Tool (CAIT) Score
  • Time Frame: at two years
    Safety Issue?: Yes
• Number of lesions in the group echography/stress radiography versus in the group echography.
  • Time Frame: at the clinical examination
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Grenoble

Overall Clinical Trial Officials and Contacts

Jean-Jacques Banihachemi Principal Investigator University Hospital, Grenoble  

Overall Contact: Jean-Luc Cracowski, MD 0033476769260 JLCracowski@chu-grenoble.fr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00639028

Study ID Number: DCIC 07 02

ClinicalTrials.gov Identifier: NCT00639028

Health Authority: France: Afssaps - French Health Products Safety Agency