NCT01564654已完成不适用
A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System
Restor3D4 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2012年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- Knee Function
研究概览
简要总结
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical condition included in the approved Indications For Use
- •Has signed the informed consent form to allow review of medical records and collection of data therein.
- •> 18 years of age
排除标准
- •Treatment with iTotal in a manner inconsistent with Instructions for Use
- •Unwilling to sign then informed consent form
结局指标
主要结局
Knee Function
时间窗: Average of 7 months post-operative
Range of Motion
次要结局
- Number of Transfusions(Initial hospital stay)
- Manipulations Under Anesthesia(Up to 7 months post-operative)
- Revision Rate(Average of 7 months)
研究者
研究点 (4)
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