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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Grenoble、フランス、38100
- Emergency department - University Hospital of Grenoble South
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：1
Ankle echography
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Ankle echography
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|
他の：2
echography + stress radiography
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Ankle echography + stress radiography
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他の：3
stress radiography
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ankle stress radiography
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
時間枠：at one year
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at one year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Lower Extremity Functional Squale (LEFS) Score
時間枠：at one year
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at one year
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Lower Extremity Functional Squale (LEFS) Score
時間枠：at two years
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at two years
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Baecke Physical Activity Questionnaire Score
時間枠：at the clinical examination
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at the clinical examination
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Cumberland Ankle Instability Tool (CAIT) Score
時間枠：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.
時間枠：at the clinical examination
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at the clinical examination
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協力者と研究者
捜査官
- 主任研究者：Jean-Jacques Banihachemi、University Hospital, Grenoble
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Ankle echographyの臨床試験
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National Taiwan University HospitalNational Science Council, Taiwanわからない
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Imperial College Healthcare NHS Trust完了
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Bahçeşehir UniversityNevsehir Haci Bektas Veli Universityまだ募集していません