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临床试验/NCT00862511
NCT00862511已完成不适用

A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses

Technische Universität Dresden2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
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

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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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