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Clinical Trials/NCT00639028
NCT00639028
Completed
Not Applicable

Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.

University Hospital, Grenoble1 site in 1 country390 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lateral Ankle Sprain
Sponsor
University Hospital, Grenoble
Enrollment
390
Locations
1
Primary Endpoint
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
January 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Lateral ankle sprain.
  • Sprain occurred for less than 48 hours.
  • Age between 18 and
  • 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.

Outcomes

Primary Outcomes

Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)

Time Frame: at one year

Secondary Outcomes

  • Baecke Physical Activity Questionnaire Score(at the clinical examination)
  • Cumberland Ankle Instability Tool (CAIT) Score(at two years)
  • Lower Extremity Functional Squale (LEFS) Score(at two years)
  • Number of lesions in the group echography/stress radiography versus in the group echography.(at the clinical examination)

Study Sites (1)

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