Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS) (TALOS)

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 Overview

• Status: Completed
• Conditions: Lateral Ankle Sprain
• Intervention / Treatment: Other: Ankle echography; Other: Ankle echography + stress radiography; Other: stress radiography

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.

• Study Type: Interventional
• Enrollment (Anticipated): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38100
    • Emergency department - University Hospital of Grenoble South

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Ankle echography	Other: Ankle echography; Ankle echography
Other: 2; echography + stress radiography	Other: Ankle echography + stress radiography; Ankle echography + stress radiography
Other: 3; stress radiography	Other: stress radiography; ankle stress radiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)	at one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Jacques Banihachemi, University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Estimate): January 23, 2014
• Last Update Submitted That Met QC Criteria: January 22, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: injury; ankle; diagnosis; ultrasonography; sprain; care; stress radiography
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: DCIC 07 02