Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- - X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
研究概览
简要总结
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
详细描述
Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.
The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.
These clinical facts need of course to be validated.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
- •age 60 years or older
排除标准
- •open fracture
- •fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
- •polytraumatized patient
- •fractures older than 15 days
- •infection of the operating site
- •previous osseous disease
结局指标
主要结局
- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)
时间窗: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths
次要结局
- PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)(2 weeks, 5 weeks, 3, 6 and 12 months)
- Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)(5 weeks, 3, 6 and 12 months)
- Grip and pinch strength (5 weeks, 3, 6 and 12 months)(5 weeks, 3, 6 and 12 months)