Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
Study NCT ID:
NCT00639028
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2008-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-22', 'studyFirstSubmitDate': '2008-03-11', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)', 'timeFrame': 'at one year'}], 'secondaryOutcomes': [{'measure': 'Lower Extremity Functional Squale (LEFS) Score', 'timeFrame': 'at one year'}, {'measure': 'Lower Extremity Functional Squale (LEFS) Score', 'timeFrame': 'at two years'}, {'measure': 'Baecke Physical Activity Questionnaire Score', 'timeFrame': 'at the clinical examination'}, {'measure': 'Cumberland Ankle Instability Tool (CAIT) Score', 'timeFrame': 'at two years'}, {'measure': 'Number of lesions in the group echography/stress radiography versus in the group echography.', 'timeFrame': 'at the clinical examination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ankle', 'diagnosis', 'sprain', 'care', 'injury', 'stress radiography', 'ultrasonography'], 'conditions': ['Lateral Ankle Sprain']}, 'referencesModule': {'references': [{'pmid': '8578138', 'type': 'BACKGROUND', '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.'}, {'pmid': '10101985', 'type': 'BACKGROUND', '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.'}, {'pmid': '10874392', 'type': 'BACKGROUND', 'citation': 'Brasseur JL, Tardieu M. [Accurate use of imaging in ankle sprain]. JBR-BTR. 1999 Apr;82(2):63-8. French.'}, {'pmid': '1554068', 'type': 'BACKGROUND', '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.'}, {'pmid': '16308555', 'type': 'BACKGROUND', '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.'}, {'pmid': '16935061', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The lateral ankle sprain is the most frequent purpose of consultation in emergency traumatology of the locomotive system.\n\nIf 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.\n\nConsidering the difficulty of the clinical estimation, additional examinations aim to support the positive diagnosis, to clarify the gravity and to dismiss differential diagnosis.\n\nThus 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lateral ankle sprain.\n* Sprain occurred for less than 48 hours.\n* Age between 18 and 55.\n* Person affiliated at the Social Security.\n\nExclusion Criteria:\n\n* Recurrent lateral ankle sprain occurred for less than 2 years and diagnosed by a doctor.\n* Bilateral sprain, medio-tarsal sprain, syndesmosis sprain, subtalar sprain.\n* Tendinous luxation (fibular, posterior tibial).\n* Homolateral ankle fracture occurred for less than 2 years.\n* Cuboid fracture, external tubercle of astragalus fracture, calcaneum fracture, fracture of the talus extremity, base of the fifth metatarsal bone fracture.\n* Tearing of internal malleolus, tearing of astragalus posterior tubercle.\n* Osteochondral lesions of the astragalus dome.\n* Probable difficulty to follow up the patient.\n* Patient taking anticoagulant.\n* Pregnant woman, parturient, breast-feeding mother.\n* Person deprived of freedom after a judicial or an administrative decision, person with legal protection measure.'}, 'identificationModule': {'nctId': 'NCT00639028', 'acronym': 'TALOS', 'briefTitle': 'Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprain (TALOS)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.', 'orgStudyIdInfo': {'id': 'DCIC 07 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Ankle echography', 'interventionNames': ['Other: Ankle echography']}, {'type': 'OTHER', 'label': '2', 'description': 'echography + stress radiography', 'interventionNames': ['Other: Ankle echography + stress radiography']}, {'type': 'OTHER', 'label': '3', 'description': 'stress radiography', 'interventionNames': ['Other: stress radiography']}], 'interventions': [{'name': 'Ankle echography', 'type': 'OTHER', 'description': 'Ankle echography', 'armGroupLabels': ['1']}, {'name': 'Ankle echography + stress radiography', 'type': 'OTHER', 'description': 'Ankle echography + stress radiography', 'armGroupLabels': ['2']}, {'name': 'stress radiography', 'type': 'OTHER', 'description': 'ankle stress radiography', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Grenoble', 'country': 'France', 'facility': 'Emergency department - University Hospital of Grenoble South', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Jacques Banihachemi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}