NCT02831595终止不适用
Effectiveness of Titanium Niobium Nitride Coating in Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 主要终点
- Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months
研究概览
简要总结
Modern knee implants combine several types of metal and therefore potentially expose patients to different metal ions.
Titanium niobium nitride coating (TiNbN) acts like a physical barrier against the corrosion process and the metallic ions release towards the surrounding biologic environment, thus, making TiNbN-coated prostheses possible to be safety implanted in metal sensitized patients.
The aim of the study is to verify that the postoperative plasma metal concentrations at 1 year are not different than preoperative values.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients candidate for unilateral primary total knee arthroplasty
排除标准
- •Existing orthopaedic metal implants
- •A history of hypersensitivity to metals
- •Preoperative patch-test positivity to Co, Cr, Ni and Ti
- •Malignancies
- •Renal insufficiency
- •Severe illnesses that would impair participation in this study
结局指标
主要结局
Change from baseline plasma metal ion concentrations (Co, Cr, Ni) at 12 months
时间窗: Preoperative and at 12 months follow-up
次要结局
- Number of patients with metal sensitivity at 1 year tested by patch-testing(1 year follow-up)
研究者
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