NCT02663804已完成不适用
Total Knee Arthroplasty: Relation Between Patient Satisfaction and Implant Geometry
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Patient Satisfaction
研究概览
简要总结
A RCT (randomized controlled trial) comparing 3 different TKA (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of all ages, scheduled for TKA
- •Primary osteoarthritis of the knee joint
- •post traumatic arthritis
- •rheumatoid arthritis
排除标准
- •previous TKA in same joint
- •evidence of neuromuscular or neurosensory deficiency
- •immunologic suppression
研究组 & 干预措施
Implant design 1
Active Comparator
Journey II, BCS, Smith&Nephew
干预措施: Total Knee Arthroplasty (Device)
Implant design 2
Active Comparator
Persona, Zimmer
干预措施: Total Knee Arthroplasty (Device)
Implant design 3
Active Comparator
Unity, Corin
干预措施: Total Knee Arthroplasty (Device)
结局指标
主要结局
Patient Satisfaction
时间窗: 2 years postoperative
Determining patient specific factors by use of validated questionnaires
次要结局
未报告次要终点
研究者
研究点 (2)
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