NCT01098604已完成4 期
The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty: A Randomized Clinical Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- rate of dislocation in each head size
研究概览
简要总结
It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.
The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.
The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteonecrosis of femoral head
- •primary or secondary osteoarthritis of the hips
- •femoral neck fracture
排除标准
- •previous hemi- or total hip arthroplasty
- •highly dislocated or severe ankylosed hip
- •patients who are considered potentially unreliable or who may not reliably attend study visits
结局指标
主要结局
rate of dislocation in each head size
时间窗: 24 months
to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.
次要结局
- clinical results using Harris Hip Score(24 months)
研究者
研究点 (2)
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