NCT01010828已完成不适用
Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Force from femoral and tibial side to retract and bring visual field into view
研究概览
简要总结
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects.
排除标准
- •Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.)
研究组 & 干预措施
Tri-Vector Approach
Active Comparator
干预措施: Incision technique (Procedure)
Mini Mid-Vastus Approach
Experimental
干预措施: Incision technique (Procedure)
结局指标
主要结局
Force from femoral and tibial side to retract and bring visual field into view
时间窗: intraoperatively
次要结局
- Incision length(intraoperatively)
- Visual determination of the extension and flexion gap(intraoperatively)
研究者
研究点 (2)
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