NCT01441817已完成不适用
Non--operative Treatment of the Medial Malleolus in bi- and Trimalleolar Ankle Fractures. A Randomized Controlled Trial
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
研究概览
简要总结
The purpose of this study was to determine if internal fixation of the medial malleolus is necessary following open reduction and internal fixation of the lateral and, if required, the posterior malleolus treating displaced bi-or trimalleolar ankle fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Orthopaedic Trauma Association (OTA) type 44 fractures (B2-3 and C2-3).
排除标准
- •Patients with OTA type 43 distal tibia fractures.
- •Patients with soft tissue injuries involving the medial malleolus.
结局指标
主要结局
American Orthopaedic Foot and Ankle Society ankle hind foot score (AOFAS)
时间窗: Average of 42 months
The Olerud Molander Ankle score (OMAS)
时间窗: Average of 42 months
次要结局
- Posttraumatic osteoarthritis (OA) according to the criteria of Magnusson (stage I-IV)(Average of 42 months)
- VAS score(Average of 42 months)
研究者
研究点 (2)
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