NCT02108327已完成不适用
Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- •age 50-85 years old
- •ASA class 1-3
排除标准
- •unable to perform spinal anaesthesia
- •history of coagulation disorder
- •renal impairment (CrCl <30 mL/min) or cirrhosis
- •platelet count < 100,000 or abnormal coagulogram
- •on pacemaker
- •stop anti-platelet or anti-coagulogram less than 7 days
结局指标
主要结局
Blood loss
时间窗: 48 hours
- detected total blood loss from hemoglobin at 24,48 hours after surgery, maximum Hb drop and blood loss collected in radivac drain
次要结局
- inflammation(48 hours)
- knee range of motion(3 months)
- Knee function(3 months)
- complication(2 weeks)
研究者
Supakit Kanitnate
principal investigator
Thammasat University
研究点 (2)
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