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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00639028
First received: March 11, 2008
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Lateral Ankle Sprain
 Other: Ankle echography
Other: Ankle echography + stress radiography
Other: stress radiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT) [ Time Frame: at one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Lower Extremity Functional Squale (LEFS) Score [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
  • Lower Extremity Functional Squale (LEFS) Score [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
  • Baecke Physical Activity Questionnaire Score [ Time Frame: at the clinical examination ] [ Designated as safety issue: No ]
  • Cumberland Ankle Instability Tool (CAIT) Score [ Time Frame: at two years ] [ Designated as safety issue: Yes ]
  • Number of lesions in the group echography/stress radiography versus in the group echography. [ Time Frame: at the clinical examination ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 390
Study Start Date: November 2007
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Ankle echography
 Other: Ankle echography
Ankle echography
2
echography + stress radiography
 Other: Ankle echography + stress radiography
Ankle echography + stress radiography
3
stress radiography
 Other: stress radiography
ankle 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639028

Locations
France
Emergency department - University Hospital of Grenoble South
Grenoble, France, 38100
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Jacques Banihachemi University Hospital, Grenoble
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00639028     History of Changes
Other Study ID Numbers: DCIC 07 02
Study First Received: March 11, 2008
Last Updated: January 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
ankle
diagnosis
sprain
care
 injury
stress radiography
ultrasonography

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 23, 2013