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临床试验/NCT02102581
NCT02102581已完成不适用

Evaluation of Short-term Effects of Tourniquet Use in Different Ways During Total Knee Arthroplasty: a Randomized Controlled Trial

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14

研究概览

简要总结

To study the short-term effects of tourniquet use in different ways in total knee arthroplasty,60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.Investigators want to observe the difference between the two groups. Hypothesis was made that patients in group B may feel better after operation for short time use of tourniquet.

详细描述

Objective

To study the short-term effects of tourniquet use in different ways in total knee arthroplasty.

Methods: 60 patients were randomly divided into 2 groups (30 cases/group): group A using the tourniquet throughout the operation, and group B using the tourniquet starting from the implantation of prosthesis to the completion of the operation. Operation time, total measured blood loss, intraoperative transfusion volume, and complication were recorded. Hemoglobin level was recorded preoperatively and in postoperative 1, 3, 7 and 14 days, and the limb circumference, pain score, and knee joint range of motion were also recorded preoperatively and in postoperative 3,7 and 14 days.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients eligible for the study included those who underwent initial unilateral TKA for osteoarthritis or rheumatoid arthritis.

排除标准

  • Patients with diabetes, hemorrhagic disease, Hb < 100 g/L, peripheral neurovascular disease, malignant tumors, history of vascular thrombosis, or history of infection in the lower limb were excluded

结局指标

主要结局

the limb circumference at 10 cm above the knee at postoperative day 1,3,7 and 14

时间窗: 14 days after the surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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