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临床试验/NCT03424174
NCT03424174进行中(未招募)不适用

Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA

Technische Universität Dresden2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
2
主要终点
cytokine expression

研究概览

简要总结

Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results

详细描述

Comparison of coated and uncoated TKA with regard to cytokine expression and clinical results at 3 months, 1 year and 3 years after surgery

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary and secondary osteoarthritis
  • understanding of german language

排除标准

  • necessity of constrained TKA
  • existence of other joint implants

结局指标

主要结局

cytokine expression

时间窗: pre-op, 1 and 3 years post-op

Changes of cytokine expression 1 and 3 years after surgery compared to pre-op

次要结局

  • Patient reported outcome assessed with Oxford Knee Score(pre-op, 3 months, 1 and 3 years post-op)
  • Quality of life assessed with EQ 5D(pre-op, 3 months, 1 and 3 years post-op)
  • Function assessed with Knee Society Score(pre-op, 3 months, 1 and 3 years post-op)
  • Activity assessed with UCLA activity score(pre-op, 3 months, 1 and 3 years post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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