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

Lateral Ankle Sprain Clinical Trial

— TALOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639028
• Other study ID #: DCIC 07 02
• Status: Completed
• Phase: N/A
• First received: March 11, 2008
• Last updated: January 22, 2014
• Start date: November 2007
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ankle Injuries
• Lateral Ankle Sprain

Intervention

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

Locations

Country	Name	City	State
France	Emergency department - University Hospital of Grenoble South	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (6)

Brasseur JL, Morvan G, Godoc B. [Dynamic ultrasonography]. J Radiol. 2005 Dec;86(12 Pt 2):1904-10. Review. French. — View Citation

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

Picard F, Tourné Y, Montbarbon E, Saragaglia D. [Ankle trauma. Diagnostic orientation]. Rev Prat. 1995 Nov 15;45(18):2335-42. French. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)		at one year	Yes
Secondary	Lower Extremity Functional Squale (LEFS) Score		at one year	Yes
Secondary	Lower Extremity Functional Squale (LEFS) Score		at two years	Yes
Secondary	Baecke Physical Activity Questionnaire Score		at the clinical examination	No
Secondary	Cumberland Ankle Instability Tool (CAIT) Score		at two years	Yes
Secondary	Number of lesions in the group echography/stress radiography versus in the group echography.		at the clinical examination	Yes