NCT00862511已完成不适用
A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses
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
- 120
- 试验地点
- 1
- 主要终点
- Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)
研究概览
简要总结
All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for TKA in primary oder secondary osteoarthritis of the knee
- •Patient's consent
排除标准
- •Additional Implants present
- •Allergy against constituents of implant or cement
- •Any malignancies
- •Renal insufficiency
- •Any additional serious disease complicating the participation in this study
研究组 & 干预措施
Coated Total Knee Arthroplasty
Experimental
allergy coated TKA
干预措施: Coated Total Knee Arthroplasty (Device)
Standard Total Knee Arthroplasty
Active Comparator
normal TKA
干预措施: Standard Total Knee Arthroplasty (Device)
结局指标
主要结局
Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)
时间窗: 1 y and 5y
次要结局
- Hypersensitivity against metal(1 y)
研究者
研究点 (1)
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