NCT01484366终止不适用
Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- implant pain
研究概览
简要总结
The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points:
- a lower rate of implant pain
- a lower re-operation rate to remove painful hardware.
详细描述
This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diaphyseal fractures of both radius and ulna
- •Ulna fractures that are oblique or transverse
- •Fractures may be closed or Grade I-IIIA open
- •Patients must be over 18 and skeletally mature
排除标准
- •Children under the age of 18
- •Pregnancy
- •Comminuted ulna fractures
- •Those with associated bony elbow or wrist trauma
- •Elbow dislocation
- •Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)
研究组 & 干预措施
intramedullary nailing and plating
Active Comparator
intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures
干预措施: intramedullary nailing and plating (Procedure)
plating
Active Comparator
plating of both the radius and ulna in the treatment of both bone forearm fractures
干预措施: plating (Procedure)
结局指标
主要结局
implant pain
时间窗: 1 year
a visual analog scale (VAS) will be used to assess pain in the forearm
次要结局
- re-operation rate to remove painful hardware(1 year)
研究者
研究点 (2)
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