NCT00908895已完成3 期
Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
Hopital de l'Enfant-Jesus2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2003年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The Grip Strength
研究概览
简要总结
The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.
The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.
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
- Single (Outcomes Assessor)
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
- •Distal radius fracture Frykman I or II
- •Unstable fracture according to Lafontaine's criteria
- •Fracture line more than 1cm form the joint line
- •Closed fracture
- •Age > 18 years
- •Surgery performed between 72 hours from the trauma
- •Monotrauma
- •Patient signed the informed consent
排除标准
- •Distal radius fracture Frykman III-VI (intra-articular fracture)
- •Open fracture
- •Polytraumatism
- •Stable or non-displaced fracture
结局指标
主要结局
The Grip Strength
时间窗: 6 months
Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
次要结局
- Range of Movement of Wrist(6 months)
研究者
研究点 (2)
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