Study on the Post-operative Effect of Applying Drainage on Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- The change of bleeding volume in perioperative period
研究概览
简要总结
This multicenter clinical trial aims to investigate the exact effect of drainage use for osteoarthritis patients in total knee arthroplasty (TKA) on post-operative performance.
详细描述
This is a multicenter,open-label randomized controlled trail. A total of 100 participants will receive same perioperative treatment schedule, and all surgeries will be carried out by the same surgeon. Among all the participants, 50 patients will be randomly assigned to the experiment group in which a drainage will be applied during the surgery, while another 50 patients will be randomly assigned to the control group without a drainage application in the surgery.Data on perioperative bleeding volume, swelling of lower extremities, pain score will be collected and analysed.
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
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ready to receive single-side TKA
- •Be evaluated as ASA 1-2 degree before operation
排除标准
- •coagulation disorder
- •peripheral vessel diseases
- •contraindication of surgery
研究组 & 干预措施
drainage
A drainage will be applied in this group.
干预措施: drainage (Procedure)
without drainage
Non-drainage will be applied in this group.
干预措施: non-drainage (Procedure)
结局指标
主要结局
The change of bleeding volume in perioperative period
时间窗: before operation and one week after operation
The difference between baseline Hct collected before operation and Hct collected one week after operation
次要结局
- Pain(one week after operation)
- Range of motion(one week after operation)
- Swelling of the lower extremities(one week after operation)
研究者
Lin Chutong
The clinical professor of arthritis clinic and research center
Peking University People's Hospital