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临床试验/NCT04130009
NCT04130009已完成不适用

Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Hawler Medical University0 个研究点目标入组 70 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
Visual Analogue score for thigh pain

研究概览

简要总结

Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B

详细描述

This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters:

Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively.

Clinical DVT.

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
48 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment

排除标准

  • •Hb less than
  • •D.M.,Blood dyscrasia.
  • •Any evidence of infection by screening test ESR and CRP. ,
  • •BMI more than 30.

研究组 & 干预措施

TKA with tourniquet

Active Comparator

This group was treated by TKA with the use of tourniquet

干预措施: Tourniquet use (Procedure)

TKA without tourniquet

Active Comparator

This group was treated by TKA without tourniquet

干预措施: Tourniquet use (Procedure)

结局指标

主要结局

Visual Analogue score for thigh pain

时间窗: The VAS for thigh pain was measured in the day 14 after operation

This is measurement of the degree of thigh pain after operation which range from zero to 10

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherwan Ahmed Ali Hamawandi

assistant professor of orthopedic surgery

Hawler Medical University

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