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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 currently recruiting participants.
Verified by University Hospital, Grenoble, March 2008

Sponsored by: University Hospital, Grenoble
Information provided by: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00639028
  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

MedlinePlus related topics:   Stress    Ultrasound    X-Rays   

ChemIDplus related topics:   X-Rays   

U.S. FDA Resources

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

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:   October 2007
Estimated Study Completion Date:   November 2010
Estimated Primary Completion Date:   September 2010 (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.
  • Accident at work.
  • 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

Contacts
Contact: Jean-Luc Cracowski, MD     0033476769260     JLCracowski@chu-grenoble.fr    

Locations
France
Emergency department - University Hospital of Grenoble South     Recruiting
      Grenoble, France, 38100
      Contact: Jean-Jacques Banihachemi     0033476765423     JJBanihachemi@chu-grenoble.fr    
      Sub-Investigator: Christophe Chaussard            
      Sub-Investigator: Jean-Noël Ravey            

Sponsors and Collaborators
University Hospital, Grenoble

Investigators
Principal Investigator:     Jean-Jacques Banihachemi     University Hospital, Grenoble    
  More Information


Publications:

Responsible Party:   Direction de la Recherche Clinique, CHU de Grenoble, 38043 Grenoble Cedex 09 ( M. Eric Svahn )
Study ID Numbers:   DCIC 07 02
First Received:   March 11, 2008
Last Updated:   March 18, 2008
ClinicalTrials.gov Identifier:   NCT00639028
Health Authority:   France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Wounds and Injuries
Disorders of Environmental Origin
Stress
Sprains and Strains

ClinicalTrials.gov processed this record on October 10, 2008




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