JPRN-jRCTs032180333已完成未知
Multicenter clinical study to assess the effectiveness and safety of Aquala liner in total hip arthroplasty - AQUALA study
Tanaka Takeyuki0 个研究点目标入组 760 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 760
研究概览
简要总结
In this study, we evaluated subjects who were performed primary THA using a research medical device (Aquala liner). As a result, the steady-state wear rate of the Aquala liner was significantly lower than that of the historical control group(p<0.001). Assessment of hip function, activity levels, and health status all improved postoperatively. The survival rate was 98.3%, which was superior to the survival rate for conventional artificial hip joint.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 75age old（—）
- 性别
- All
入选标准
- •*Patients who are indicated for a primary THA, and entered this study on the basis of their agreement to participate in the clinical trial. Patients who are indicated for this surgery on both sides can be included.
- •*Patients who have an indication for the Aquala liner with a femoral head of 28 mm or 32 mm in diameter.
排除标准
- •*Patients who are not indicated for a primary THA
- •*Patients with unstable clinical conditions
- •*Patients whose weight is over the weight restriction of the femoral components to be used
研究者
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