Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.
详细描述
A single type of femoral component with 3 different HA coatings will be evaluated in this study. Patients with fractured neck of femur requiring hemi-arthroplasty will be recruited. Safety and performance of the device will be determined by adverse events (device related or non-related), survival and histological exam.
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
- •Fractured neck of femur requiring hemi-arthroplasty. Selection of subjects for this evaluation should include the following considerations:-.
- •A likelihood of obtaining relief of pain and improved function.
- •Full skeletal maturity.
- •Ability to follow instructions.
- •Good general health for age.
- •Willing to return for follow-up evaluations .
- •No bias to sex.
排除标准
- 未提供
研究组 & 干预措施
1
Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA
干预措施: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA (Device)
2
干预措施: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA (Device)
3
干预措施: Hip stem with Interloc Titanium surface + Bonemaster H.A (Device)
结局指标
主要结局
Adverse Event
时间窗: Anytime
次要结局
- Histological Exam(Anytime)