Electromagnetic Navigation System Versus Freehand Technique in Total Hip Arthroplasty: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Acetabular component position
研究概览
简要总结
A prospective randomized study comparing accuracy and precision of acetabular component placement in total hip arthroplasty with use of novel electromagnetic navigation system versus freehand technique.
详细描述
Patients with hip arthritis, who are to be treated with total hip arthroplasty will be randomized in two groups. Patents allocated to study group will get their acetabular components implanted with the help of electromagnetic navigation system. Patients allocated to the control group will get their acetabular components implanted with freehand technique. Accuracy and precision of implanted acetabular components will be assessed on images obtained by postoperative computed tomography. Postoperative inclination and anteversion angles of acetabular components will be measured by the independent technician. Results will be statistically analyzed and compared.
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
- Single (Outcomes Assessor)
盲法说明
Postoperative computed tomography measurements of acetabular component position will be done by independent technician.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 18 years
- •unilateral surgery
- •osteoarthritis of the hip
- •no previous surgery on the affected hip
- •implantation of the same acetabular component through the same approach
- •signed informed consent
排除标准
- •age under 18 years
- •unwilling to participate
- •prior surgery on affected hip
结局指标
主要结局
Acetabular component position
时间窗: Up to 48 hours after surgery
Comparison of the precision and the accuracy of acetabular components between both groups
次要结局
- Surgical time(Immediately after surgical procedure)
- Clinical result(8-10 weeks postoperatively)