Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
研究概览
简要总结
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
详细描述
The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.
All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who are scheduled for a standard total knee replacement
- •Patient who are scheduled for patient-specific total knee replacement (iTotal)
- •Patient age > 18 years
排除标准
- •Patients who do not receive a total knee replacement
- •Unwilling or unable to comply with study requirements
结局指标
主要结局
Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
时间窗: Intraoperatively, up to 120 minutes
Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.
Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
时间窗: Intraoperatively, up to 120 minutes
Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.
次要结局
未报告次要终点