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CompletedNCT00639028TALOSUpdated Jan 23, 2014

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

An interventional study of Ankle echography and Ankle echography + stress radiography in Lateral Ankle Sprain, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-01-23.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
390
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lateral Ankle Sprain

Keywords

  • ankle
  • diagnosis
  • sprain
  • care
  • injury
  • stress radiography
  • ultrasonography
03

In context

Disease

1,382 studies on the registry are indexed under Disease; 612 are open to participants now.

This study's planned enrollment of 390 is above the median of 80 across 762 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.

Browse University Hospital, Grenoble studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
390 participants (estimated)

Study arms

  • Other
    1

    Ankle echography

    Other: Ankle echography

  • Other
    2

    echography + stress radiography

    Other: Ankle echography + stress radiography

  • Other
    3

    stress radiography

    Other: stress radiography

Interventions

  • OtherAnkle echography

    Ankle echography

  • OtherAnkle echography + stress radiography

    Ankle echography + stress radiography

  • Otherstress radiography

    ankle stress radiography

06

What researchers measure

Primary outcomes

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

    Time frame: at one year

Secondary outcomes

  1. Lower Extremity Functional Squale (LEFS) Score

    Time frame: at one year

  2. Lower Extremity Functional Squale (LEFS) Score

    Time frame: at two years

  3. Baecke Physical Activity Questionnaire Score

    Time frame: at the clinical examination

  4. Cumberland Ankle Instability Tool (CAIT) Score

    Time frame: at two years

  5. Number of lesions in the group echography/stress radiography versus in the group echography.

    Time frame: at the clinical examination

07

Study locations

1 site
  • Emergency department - University Hospital of Grenoble South
    Grenoble, 38100, France
08

References and documents

Publications

  • 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. PubMed 8578138 ↗
  • 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. PubMed 10101985 ↗
  • Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French. PubMed 10874392 ↗
  • 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. PubMed 1554068 ↗
  • 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. PubMed 16308555 ↗
  • 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. PubMed 16935061 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Dec 2013 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2008
First posted
Mar 19, 2008
Start
Nov 2007
Primary completionActual
Dec 2013
CompletionActual
Jan 2014
Last update
Jan 23, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00639028
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Mar 19, 2008
Start date
Nov 2007
Primary completion
Dec 2013
Completion
Jan 2014
Last update
Jan 23, 2014

Study contacts

Jean-Jacques Banihachemi
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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