NCT01670344已完成不适用
Virtual Implant Planning System - A Method to Support Image-guided Surgical Interventions
Siemens Healthcare QT2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年7月1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
- 80
- 试验地点
- 2
- 主要终点
- Number of screw replacements in both treatments arms
研究概览
简要总结
This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.
Aim of the study is the validation and comparison of the innovative medical device with the current standard method.
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
- •Patients with diastal fracture of the radius
- •Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
- •Age >/= 18 years of age
- •Patients willing to participate and after having given their informed consent in written form
排除标准
- •Participation in other interventional clinical trials
- •Pregnant or lactating women
结局指标
主要结局
Number of screw replacements in both treatments arms
时间窗: Participants will be followed for the duration of the hospital stay, an expected average of 3 days
The number of screw replacements in both treatment arms will be assessed to evaluate the investigational method in comparison to the standard of care (arm B)
次要结局
- Comparison of the investigational method to the standard of care regarding radiation time.(Participants will be followed for the duration of the hospital stay, an expected average of 3 days)
- Number of adverse events and serious adverse events during the clinical investigarion.(Participants will be followed for the duration of the hospital stay, an expected average of 3 days)
研究者
研究点 (2)
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