ISRCTN31379280已完成不适用
A randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a displaced fracture of the distal radius
niversity of Warwick (UK)0 个研究点目标入组 390 人开始时间: 2010年3月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3 cm of the radio-carpal joint
- •2. The treating Consultant Surgeon believes that they would benefit from operative fixation of the fracture
- •3. Aged over 18 years (either sex) and able to give informed consent
排除标准
- •1. The fracture extends more than 3 cm from radio-carpal joint
- •2. The fracture is open with a Gustillo grading greater than 1
- •3. The articular surface of the fracture cannot be reduced by indirect techniques (in a small number of fractures, the joint surface is so badly disrupted that the surgeon will have to open up the fracture in order to restore the anatomy under direct vision)
- •4. There are contra-indications to surgery, defined as:
- •4.1. Severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction
- •4.2. Severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission
- •4.3. Any other systemic medical condition that would produce a specific contraindication to a general anaesthetic
- •5. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as cognitive impairment or intravenous drug abuse
研究者
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