The PRO-malleol Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in re-operation rate
研究概览
简要总结
There is a high incidence of re-operations after surgery for ankle fractures. According to the Danish Fracture Database (DFDB) the re-operation rate, excluding hardware removal, is almost 10%.
We are conducting a study on the efficacy of an evidence based algorithm for the treatment of ankle fractures.
详细描述
Treatment of ankle fractures is complex and includes assessment of fracture pattern, severity of soft-tissue involvement and general health- and functional status of the patients. Historically most fractures, undisplaced as well as displaced, were treated non-operatively with acceptable results but in recent years there is an increasing trend towards operative management of unstable fractures. Techniques for operative management of ankle fractures are varied and assessment of instability is mainly based on classic x-ray classification systems such as Lauge-Hansen or the AO that are difficult to reproduce[6].
We hypothesize that a standardized and evidence based approach to ankle fracture management will lead to a decrease in re-operation rate.
The aim of this study is to standardize the management of ankle fractures in our department, by introducing an algorithm based on best evidence present. We want to investigate:
- The effect of this algorithm on the re-operation rate of surgically treated ankle fractures in a two-year prospective observational setup with a minimum of one-year of follow-up.
- The need for surgery and functional outcome of patients with isolated lateral malleolus fractures in which the treatment is dictated by ankle stability assessed on weight bearing radiographs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •All patients treated for ankle fractures at our institution during the study period are asked to participate in the study.
排除标准
- •Not speaking danish Not followed up at our institution Not mentally capable of filling out questionnaire
结局指标
主要结局
Change in re-operation rate
时间窗: one year
Change in re-operation rate following introduction of PRO malleol algorithm
Rate of surgery for isolated lateral ankle fractures
时间窗: one year
Rate of surgery for isolated lateral ankle fractures, following introduction of algorithm
次要结局
- Ollerud Molander Ankle Score(Before fracture, 6 weeks, 12 weeks and 1 year)
- Forgotten Joint Score(Before fracture, 6 weeks, 12 weeks and 1 year)
- Rate of complications not requiring surgery(One year)
- SF 36(day 0 and 12 months)
研究者
Peter Toft Tengberg
Consultant, PhD
Hvidovre University Hospital