NCT01757951暂停不适用
Unimalleolar Versus Bimalleolar Fixation in Bi- or Trimalleolar Ankle Fracture - A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Olerud-Molander Ankle Score
研究概览
简要总结
A one third of all ankle fractures are bi- or trimalleolar. Traditionally these fractures are treated by both medial and lateral osteosynthesis, sometimes accompanied by osteosynthesis of the posterior malleolus. There is significant evidence that fractures of the lateral malleolus can be treated conservatively if the medial side is stable. However, there isn't a single study comparing standard bi- or trimalleolar fixation with only medial side osteosynthesis and postoperative immobilization with a cast.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weber B bi- or trimalleolar ankle fracture (fracture of the lateral and medial malleolus +/- posterior malleolus sized under 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs)
- •Age: 16 years or older
- •Voluntary
- •Operated within 7 days of the trauma
- •Able to walk unaided before the current trauma
排除标准
- •Peripheral neuropathy
- •Pilon fracture
- •Bilateral ankle fracture
- •Concomitant tibial fracture
- •Pathological fracture
- •Active infection around the ankle
- •A previous ankle fracture on either side
- •In trimalleolar fractures, posterior malleolus fracture sized over 30% of the distal tibia joint line measured from the lateral projection of the standard ankle radiographs
- •Inadequate co-operation
- •Permanent residence outside the catchment area of the study hospital
结局指标
主要结局
Olerud-Molander Ankle Score
时间窗: 2 years
A validated, condition-specific, patient-reported measure of ankle fracture symptoms. Range from 0 to 100 points, with higher scores indicating better function
次要结局
- A 100 mm Visual Analogue Scale for function and pain (VAS)(2 years)
- The RAND 36-Item Health Survey for health-related quality-of-life (RAND-36)(2 years)
- Talocrural joint congruence(At two, four and 12 weeks, and at 2 years)
- The Foot and Ankle Outcome Score (FAOS)(2 years)
- Fracture healing(2 years)
研究者
Harri Pakarinen
MD, PhD
University of Oulu
研究点 (2)
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