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

Registration number：

 ChiCTR2000033173 

最近更新日期：

Date of Last Refreshed on：

 2020-05-22 22:22:57 

注册时间：

Date of Registration：

 2020-05-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Muhammad Tahir 

研究负责人：

Ejaz Ali Chaudhry 

Applicant：

Muhammad Tahir 

Study leader：

Ejaz Ali Chaudhry 

申请注册联系人电话：

Applicant telephone：

 +92 33 32343828

研究负责人电话：

Study leader's
telephone：

+44 73 09026936

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 doctor.muhammad.tahir@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 dr.aliejaz84@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Jinnah Postgraduate Medical Centre

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Department of Orthopaedics JPMC, Karachi, Pakistan

研究负责人通讯地址：

G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan

Applicant address：

Department of Orthopaedics JPMC, Karachi, Pakistan

Study leader's address：

G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 75500

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心

Applicant's institution：

Jinnah Postgraduate Medical Centre

研究负责人所在单位：

巴基斯坦拉合尔古尔基信托和教学医院

Affiliation of the Leader：

Ghurki Trust and Teaching hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 GTT2354

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Institutional Review Board

Name of the ethic committee：

Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2014-09-22 00:00:00

伦理委员会联系人：

Prof. Amer Aziz

Contact Name of the ethic committee：

Prof. Amer Aziz

伦理委员会联系地址：

Ghurki Trust and Teaching hospital, G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan

Contact Address of the ethic committee：

Ghurki Trust and Teaching hospital, G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

Primary sponsor：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

研究实施负责（组长）单位地址：

Ghurki Trust and Teaching hospital, G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan

Primary sponsor's address：

Ghurki Trust and Teaching hospital, G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Nil

Source(s) of funding：

nil

研究疾病：

膝骨关节炎  

Target disease：

knee osteoarthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

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  

Objectives of Study：

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

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2015-02-12 00:00:00至 To 2018-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-02-16 00:00:00 至 To 2018-01-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 117

Group：

1

Sample size：

干预措施：

tourniquet

干预措施代码：

Intervention：

tourniquet

Intervention code：

组别：

2

样本量：

 123

Group：

2

Sample size：

干预措施：

no-tourniquet

干预措施代码：

Intervention：

no-tourniquet

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

 Ghurki Teaching Trust Hospital 

单位级别：

  

Institution
hospital：

Ghurki Teaching Trust Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Patient Reported Outcomes

指标类型：

主要指标

Outcome：

Patient Reported Outcomes

Type：

Primary indicator

测量时间点：

six weeks and six months

测量方法：

Numerical Pain Rating score

Measure time point of outcome：

six weeks and six months

Measure method：

Numerical Pain Rating score

指标中文名：

Clinical Outcome

指标类型：

主要指标

Outcome：

Clinical Outcome

Type：

Primary indicator

测量时间点：

six weeks and six months

测量方法：

Oxford knee score

Measure time point of outcome：

six weeks and six months

Measure method：

Oxford knee score

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

knee

组织：

Sample Name：

knee

Tissue：

joint

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Not stated

Blinding：

Not stated

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

private message only

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

private message only

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

electronic data

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

electronic data

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-05-22 22:22:57
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