NCT02713906终止不适用
Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Materialise
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
研究概览
简要总结
The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Physically and mentally able and willing to comply with the protocol
- •Be treated for a primary total knee arthroplasty
- •Are fluent in Dutch or French
- •Sign the Informed Consent Form
- •Comply with the indications listed in the Instructions for Use
- •Be able to undergo a CT scan
排除标准
- •Fulfilling one of the contraindications mentioned in the Instructions for Use
- •A prisoner
- •Reported to have mental illness or belonged to a vulnerable population
研究组 & 干预措施
X-Ray Knee Guide group
Experimental
Total knee arthroplasy using Materialise X-Ray Knee Guides
干预措施: X-Ray Knee Guide group (Device)
结局指标
主要结局
Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods
时间窗: 2 Months post-operatively
次要结局
未报告次要终点
研究者
研究点 (2)
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