NCT01242085已完成3 期
Alignment of Total Knee Components Using Standard or Custom Instrumentation
VA Palo Alto Health Care System2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年11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
- 64
- 试验地点
- 2
- 主要终点
- Alignment of Knee - Measured Mechanical Axis From CT Data
研究概览
简要总结
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.
详细描述
Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing primary total knee replacement -
排除标准
- •patients who have hardware involving the hip, knee or ankle
结局指标
主要结局
Alignment of Knee - Measured Mechanical Axis From CT Data
时间窗: postoperatively - CT done within 1 week of surgery
the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment
次要结局
- Surgical Time(intraoperative surgical time)
研究者
steven woolson
staff surgeon
VA Palo Alto Health Care System
研究点 (2)
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