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

Primary Purpose

Lateral Ankle Sprain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ankle echography
Ankle echography + stress radiography
stress radiography
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lateral Ankle Sprain focused on measuring ankle, diagnosis, sprain, care, injury, stress radiography, ultrasonography

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emergency department - University Hospital of Grenoble South

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

1

2

3

Arm Description

Ankle echography

echography + stress radiography

stress radiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2008
Last Updated
January 22, 2014
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00639028
Brief Title
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)
Acronym
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Ankle Sprain
Keywords
ankle, diagnosis, sprain, care, injury, stress radiography, ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Ankle echography
Arm Title
2
Arm Type
Other
Arm Description
echography + stress radiography
Arm Title
3
Arm Type
Other
Arm Description
stress radiography
Intervention Type
Other
Intervention Name(s)
Ankle echography
Intervention Description
Ankle echography
Intervention Type
Other
Intervention Name(s)
Ankle echography + stress radiography
Intervention Description
Ankle echography + stress radiography
Intervention Type
Other
Intervention Name(s)
stress radiography
Intervention Description
ankle stress radiography
Primary Outcome Measure Information:
Title
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
Time Frame
at one year
Secondary Outcome Measure Information:
Title
Lower Extremity Functional Squale (LEFS) Score
Time Frame
at one year
Title
Lower Extremity Functional Squale (LEFS) Score
Time Frame
at two years
Title
Baecke Physical Activity Questionnaire Score
Time Frame
at the clinical examination
Title
Cumberland Ankle Instability Tool (CAIT) Score
Time Frame
at two years
Title
Number of lesions in the group echography/stress radiography versus in the group echography.
Time Frame
at the clinical examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Banihachemi
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency department - University Hospital of Grenoble South
City
Grenoble
ZIP/Postal Code
38100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
8578138
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.
Results Reference
background
PubMed Identifier
10101985
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.
Results Reference
background
PubMed Identifier
10874392
Citation
Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.
Results Reference
background
PubMed Identifier
1554068
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.
Results Reference
background
PubMed Identifier
16308555
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.
Results Reference
background
PubMed Identifier
16935061
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.
Results Reference
background

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

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