NCT00755001终止不适用
Clinical Study on BiHapro Total Hip System With Different Surface Coatings
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Harris Hip Score
研究概览
简要总结
This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.
详细描述
The efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure the mineral bony thickness in the areas of Gruen zones of the proximal femur.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Harris Hip Score
时间窗: annual at least to 5 yr
次要结局
- Radiographic Assessment(Annual; At least to 5 yr)
研究者
研究点 (2)
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