Analysis of Procedure-related Costs and Proposed Benefits of the ConforMIS iTotal® Cruciate Retaining Knee Replacement System Versus Standard Total Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
研究概览
简要总结
The purpose of this study is to evaluate the costs and benefits of the ConforMIS iTotal® total knee replacement system versus standard total knee arthroplasty.
This study is designed to illustrate the difference in cost between standard total knee replacements and the ConforMIS iTotal at a single institution.
详细描述
STUDY DESIGN The study is a two-arm single-center, consecutively enrolled retrospective study. Patients enrolled will have previously received either an iTotal CR knee replacement or a standard total knee replacement. The study site will be located in the United States. A minimum of 100 with a maximum of 120 patients will be enrolled in each study arm for a maximum of 200 - 240 patients.
STUDY DURATION This study involves retrospective data collection of operative and peri-operative information to determine the cost impact of several surgical variables. The study will be complete when the retrospective data has been collected on up to 120 patients per arm.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has received an iTotal or a standard total knee replacement
- •Willingness to participate in the clinical study and to give informed consent, if necessary, as determined during IRB review
- •>18 years of age
排除标准
- •Participation in another clinical study that could confound results
- •Patient is less than 3 months post-op
结局指标
主要结局
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
时间窗: 1 month
Fixed and variable costs resulting from Total Knee Arthroplasty at 30 days post-op
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
时间窗: 3 months
Fixed and variable costs resulting from Total Knee Arthroplasty at 90 days post-op
次要结局
未报告次要终点