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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Grenoble, 프랑스, 38100
- Emergency department - University Hospital of Grenoble South
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 1
Ankle echography
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Ankle echography
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다른: 2
echography + stress radiography
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Ankle echography + stress radiography
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다른: 3
stress radiography
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ankle stress radiography
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
기간: at one year
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at one year
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Lower Extremity Functional Squale (LEFS) Score
기간: at one year
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at one year
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Lower Extremity Functional Squale (LEFS) Score
기간: at two years
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at two years
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Baecke Physical Activity Questionnaire Score
기간: at the clinical examination
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at the clinical examination
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Cumberland Ankle Instability Tool (CAIT) Score
기간: 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.
기간: at the clinical examination
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at the clinical examination
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-Jacques Banihachemi, University Hospital, Grenoble
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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