NCT03424174进行中（未招募）不适用
Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA
适应症
干预措施
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
- 1
- 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
- 否
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
研究组 & 干预措施
Coated Total Knee Arthroplasty
Experimental
Implantation coated Total Knee Arthroplasty
干预措施: Coated Total Knee Arthroplasty (Device)
Standard Total Knee Arthroplasty
Active Comparator
Implantation Standard Total Knee Arthroplasty
干预措施: Standard Total Knee Arthroplasty (Device)
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
- Quality of life assessed with EQ 5D(pre-op, 3 months, 1 and 3 years post-op)
- Patient reported outcome assessed with Oxford Knee Score(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
研究点 (1)
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