A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Patient rated wrist evaluation (PRWE)score
研究概览
简要总结
The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A
详细描述
We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dislocated extraarticular distal radius fracture age 18-70 years
排除标准
- •Cognitively impaired
- •Drug abuse
- •Congenital bone disease
- •Earlier wrist injury
- •Open fracture, Gustilo-Anderson type 3
- •Pathological fractures( except osteoporotic fractures)
研究组 & 干预措施
Volar locked plating
One group with distal radius fracture is operated with Locking plate
干预措施: Volar locked plating (Device)
Hoffman external fixator
One group with distal radius fracture is operated with Hoffman external fixator
干预措施: Hoffman external fixator (Device)
结局指标
主要结局
Patient rated wrist evaluation (PRWE)score
时间窗: 12 months
次要结局
- Pain VAS-score(6 weeks, 3 and 12 months)
- Complications(6 weeks, 3 and 12 months)
- Radiographic evaluation(6 weeks and 12 months)
- Quick-DASH score(6 weeks, 3 and 12 months)