NCT00648479终止1 期
New Method for Distal Interlocking of Cannulated Intramedullary Nails
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- the outcome will be asses using regular fluoroscopy in the operation room.
研究概览
简要总结
We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.
Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.
The allocation will be random.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing Informed consent.
- •Conscious patients.
排除标准
- •Hemodynamic Instability.
- •Multiple system injuries.
结局指标
主要结局
the outcome will be asses using regular fluoroscopy in the operation room.
次要结局
未报告次要终点
研究者
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