- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00639028
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS) (TALOS)
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Grenoble, Frankrike, 38100
- Emergency department - University Hospital of Grenoble South
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: 1
Ankle echography
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Ankle echography
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Annen: 2
echography + stress radiography
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Ankle echography + stress radiography
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Annen: 3
stress radiography
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ankle stress radiography
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
Tidsramme: at one year
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at one year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Lower Extremity Functional Squale (LEFS) Score
Tidsramme: at one year
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at one year
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Lower Extremity Functional Squale (LEFS) Score
Tidsramme: at two years
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at two years
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Baecke Physical Activity Questionnaire Score
Tidsramme: at the clinical examination
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at the clinical examination
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Cumberland Ankle Instability Tool (CAIT) Score
Tidsramme: at two years
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at two years
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Number of lesions in the group echography/stress radiography versus in the group echography.
Tidsramme: at the clinical examination
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at the clinical examination
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jean-Jacques Banihachemi, University Hospital, Grenoble
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DCIC 07 02
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