JPRN-jRCTs032180245已完成4 期
Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 32mmOX multicenter study
Kume Shinichiro0 个研究点目标入组 284 人开始时间: 2019年3月12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
- 284
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 between the two groups at 5 years after the operation, which was the primary endpoint. The secondary endpoint, PRO, also showed no consistent trend in differences between the two groups. The lack of accuracy of linear wear measurement software would be one of the factors that did not show a difference in the primary endpoint between the two groups.
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 32mm 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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