NCT01937572终止不适用
Visionaire Versus Conventional Knee Arthroplasty: A Prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Knee Society Score
研究概览
简要总结
The purpose of the current study is to validate the technology of MRI-based alignment for total knee replacements and to collect data on potential advantages of the computer aided system.
- It is hypothesized that there will be no significant differences in position, loosening, or function of the Visionaire total knee as compared to the conventional total knee.
- It is hypothesized that the Visionaire total knee will be significantly better with regard to operative time, tourniquet time, blood loss, and procedural set-up, turnover time, and overall costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with sufficient symptoms from articular knee pathology to be an appropriate candidate for TKA
排除标准
- •prior TKA
- •ipsilateral upper tibial or distal femoral osteotomy
- •ipsilateral total hip arthroplasty
- •patient with significant >15o varus or valgus
- •morbid obesity or those patients unable to have an MRI based on thigh circumference (22 cm or less)
结局指标
主要结局
Knee Society Score
时间窗: one year
次要结局
- Degrees off normal AP and lateral alignment(one year)
研究者
研究点 (2)
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