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【ChiCTR2000033173】APPLICATION OF TOURNIQUET DOES NOT INFLUENCE PATIENT REPORTED OUTCOMES OR PAIN AFTER TOTAL KNEE ARTHROLPASTY

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基本信息

登记号

ChiCTR2000033173

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2020-05-22

临床申请受理号

靶点

适应症

膝骨关节炎

试验通俗题目

APPLICATION OF TOURNIQUET DOES NOT INFLUENCE PATIENT REPORTED OUTCOMES OR PAIN AFTER TOTAL KNEE ARTHROLPASTY

试验专业题目

APPLICATION OF TOURNIQUET DOES NOT INFLUENCE PATIENT REPORTED OUTCOMES OR PAIN AFTER TOTAL KNEE ARTHROLPASTY

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

75500

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临床试验信息

试验目的

The role of the tourniquet is controversial, although tourniquets are widely used in total knee arthroplasty, due to their effectiveness in reducing blood loss. But due to lack of convincing data on patient reported outcomes (PROMS), this study aims to compare pain and functional outcomes in total knee arthroplasty patients with and without tourniquet

试验分类

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试验类型

半随机对照

试验分期

其它

随机化

The participants were undergoing 1:1 computer generated random allocation stratified by the age, gender, and body mass index, into either tourniquet or non-tourniquet group. All operations were performed under epidural anesthesia

盲法

Not stated

试验项目经费来源

Nil

试验范围

目标入组人数

117;123

实际入组人数

第一例入组时间

2015-02-12

试验终止时间

2018-07-31

是否属于一致性

入选标准

We included all primary total knee arthroplasties performed for Grade 3 and 4 osteoarthritis according to Kellgren and Lawrence System, aged between 50 and 80 years having a physical status American Society of Anesthetist (ASA) score I, II, III.；

排除标准

We excluded patients previously operated for any open knee surgery assessed on history, revision arthroplasty, body mass index greater than 40 kg/m2 ,vascular calcifications or a documented diagnosis of peripheral vascular disease, baseline lower extremity strength less than 5/5, abnormal vascular supply to the leg assessed on distal pulses, patients with bleeding disorder assessed on labs by measuring platelet count (<150,000, deranged), prothrombin time and activated partial prothrombin time, functionally limiting spine disease, other functionally limiting lower extremity disease, patients who cannot perform baseline functional assessments, any allergy or contraindication to study protocol medications, post-traumatic arthritis and inflammatory arthritis.；

研究者信息

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试验机构

Ghurki Trust and Teaching hospital, Lahore, Pakistan

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研究负责人邮编

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