JPRN-jRCTs032180273已完成4 期
Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study
Akiyama Haruhiko0 个研究点目标入组 1,302 人开始时间: 2019年3月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,302
研究概览
简要总结
In this study, subjects were assigned to femoral head groups with different materials and observed for 5 years after surgery. No significant difference was observed in the amount of polyethylene liner wire wear and PRO between the two groups. Since other national registries have suggested the superiority of OXINIUM femoral heads (Reduction of the revision rate with loosening), further discussion of differences between the studies and the validity of this study design is necessary.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Patient whose written consent was obtained to participate in the study.
- •2. Patient with indication for THA.
- •3. Patient aged 20 to 75 years old.
- •4. Patient able to implant 28mm femoral head.
- •5. Patient with UCLA score higher than 3.
- •6. Patient who has Japanese nationality.
排除标准
- •1. Revision THA
- •2. Implantation of all-polyethylene cup
- •3. Patient unable to evaluate Oxford Hip Score
- •4. Patient expected to live less than 5 years, such as cancer patients and severe patients.
研究者
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