Comparative Study of Two Radiological Modalities, Ultrasonography Versus Stress Radiography, in the Urgent Care and Prognosis of Lateral Ankle Sprains.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lateral ankle sprain.
- •Sprain occurred for less than 48 hours.
- •Age between 18 and
- •Person affiliated at the Social Security.
排除标准
- •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.
结局指标
主要结局
Residual ankle instability evaluated using the Cumberland Ankle Instability Tool (CAIT)
时间窗: at one year
次要结局
- Baecke Physical Activity Questionnaire Score(at the clinical examination)
- Cumberland Ankle Instability Tool (CAIT) Score(at two years)
- Lower Extremity Functional Squale (LEFS) Score(at two years)
- Number of lesions in the group echography/stress radiography versus in the group echography.(at the clinical examination)