NCT00804388Unknown不适用
Comparing Polyethylene Wear Using 3. Generation Highly Crosslinked Polyethylene in an Uncemented Total Hip Prostheses With Either 32 mm or 36 mm Caput of Ceramics
Lovisenberg Diakonale Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measure polyethylene wear and bone mineral density between the two groups
研究概览
简要总结
The aim of the study is to compare polyethylene wear in an uncemented total hip prosthesis with 3rd. generation highly cross-linked polyethylene with a 32 mm ceramic femoral head compared to a 36 mm ceramic head. Using X-ray, RSA and DEXA.
The polyethylene to be used is E-Poly (Biomet).
The H0 hypothesis is that there is no difference with regard to polyethylene wear and bone loss between the two groups.
详细描述
Uncemented THA, 32 mm or 36 mm caput of ceramics, E-Poly inserts. Measure wear with RSA, X-Ray and bone mineral density with DEXA.
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50-65 years old
- •Primary or secondary osteoarthritis
排除标准
- •Significant anatomical divergence are excluded
- •Rheumatoid arthritis
- •Fracture sequelae
- •Dysplasia
- •Immune suppression or grave systemic illness
结局指标
主要结局
Measure polyethylene wear and bone mineral density between the two groups
时间窗: 2 year
次要结局
未报告次要终点
研究者
研究点 (1)
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