Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 10
- 主要终点
- Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
研究概览
简要总结
The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal.
It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees.
One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks.
All patients will be followed up after 3, 6 and 12 months.
详细描述
See above
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •voluntarily, only isolated subcapital og shaft fracture of the
- •metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.
排除标准
- •open fractures, fractures of the head of
- •metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.
研究组 & 干预措施
Conservative treatment
Treated conservatively with reduction and then Plaster of Paris.
干预措施: Reduction and Plaster of Paris (Procedure)
Operation
Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires.
干预措施: Closed reduction and fixation with 2 pins (Procedure)
结局指标
主要结局
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
时间窗: 2 -3 years
The goal is 200 patients with shaft and subcapital fractures of the 5.metacarpal. In each group the goal is 100 patients there 50 patients will be operated (2 intramedullary pins) and 50 patients undergo conservative treatment. The follow up is 1 year.
次要结局
未报告次要终点