Evaluation of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures. A Prospective Randomized Multicenter Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 2
- 主要终点
- Olerud-Molander score
研究概览
简要总结
PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
详细描述
Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.
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
- 是
入选标准
- •Stable Weber-B type fibula fracture
- •ER-stress negative
- •16 or over years old
- •Willingness to participate on study proved by a signature and date
- •Walking without aid before accident
- •Treatment started within 7 days from injury
排除标准
- •Prior ankle fracture or significant fracture in the area of ankle or leg
- •Bilateral ankle fracture
- •Pathological fracture
- •Diabetes mellitus or an other significant periferial neuropathy
- •municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
- •Patient's understanding or co-operation inadequate
研究组 & 干预措施
Splint 3 weeks
Removable ankle brace/splint
干预措施: Splint 3 weeks (Other)
Cast 3 weeks
Below-the-knee cast (glass fiber)
干预措施: Cast 3 weeks (Other)
Cast 6 weeks
Below-the-knee cast (glass fiber)
干预措施: Cast 6 weeks (Other)
结局指标
主要结局
Olerud-Molander score
时间窗: 1 year
Ankle functional outcome measure
次要结局
- FAOS(1 year)
- VAS(1 year)
- Fracture healing(1 year)
- RAND 36 Health item survey(1 year)
研究者
Harri Pakarinen
Orthopedic surgeon, MD, PhD
University of Oulu