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止血带对全膝关节置换失血量、软组织损伤和骨水泥固定强度的影响:随机对照试验
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注册号:

Registration number:

ChiCTR-INR-16009026 

最近更新日期:

Date of Last Refreshed on:

2016-08-14 

注册时间:

Date of Registration:

2016-08-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

止血带对全膝关节置换失血量、软组织损伤和骨水泥固定强度的影响:随机对照试验 

Public title:

Effects of tourniquet use on blood loss, soft-tissue damage and bone cement penetration in total knee arthroplasty: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

止血带对全膝关节置换失血量、软组织损伤和骨水泥固定强度的影响:随机对照试验 

Scientific title:

Effects of tourniquet use on blood loss, soft-tissue damage and bone cement penetration in total knee arthroplasty: a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

卫计委卫生行业科研专项(201302007) 

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:

曾羿 

研究负责人:

沈彬 

Applicant:

Zeng Yi 

Study leader:

Shen Bin 

申请注册联系人电话:

Applicant telephone:

+86 13688069779 

研究负责人电话:

Study leader's telephone:

+86 18980601390 

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:

zengyigd@126.com 

研究负责人电子邮件:

Study leader's E-mail:

shenbin_1971@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

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:

四川省成都市武侯区国学巷37号华西医院骨科 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号华西医院骨科 

Applicant address:

37 Guoxuexiang, Chengdu, China 

Study leader's address:

37 Guoxuexiang, Chengdu, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

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:

2012-268 

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:

四川大学华西医院临床试验与生物医学伦理专委会 

Name of the ethic committee:

Clinical trials and biomedical ethics committee, West China Hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院骨科 

Primary sponsor:

Department of Orthopedics, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号华西医院骨科 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

华西医院

具体地址:

成都市武侯区国学巷37号

Institution
hospital:

West China Hospital

Address:

37 Guoxuexiang, Chengdu, China

经费或物资来源:

卫计委卫生行业科研专项(201302007) 

Source(s) of funding:

National Health and Family Planning Comission of the PRC, Health Industry Scientific Research (201302007) 

研究疾病:

骨关节炎 

Target disease:

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

比较骨关节患者接受全膝关节置换手术,术中是否放置止血带对围术期失血量、软组织损伤和骨水泥固定强度的影响 

Objectives of Study:

for osteoarthritis patients need total knee arthroplasty, this study will be performed to evaluate the effects of tourniquet use on blood loss, soft tissue damage and bone cement penetration.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

在我院诊断为膝关节骨关节炎并接受膝关节置换的患者 

Inclusion criteria

patients undergoing total knee arthroplasty for the treatment of osteoarthritis will be recruited for our trial 

排除标准:

接受膝关节置换的非骨关节炎患者;术前合并高血压、凝血功能障碍和周围血管疾病的患者 

Exclusion criteria:

patients undergoing total knee arthroplasty for the treatment of non-osteoarthritis disease; patients with hypertension, coagulapathy and peripheral vascular disease. 

研究实施时间:

Study execute time:

From2016-09-01To  

征募观察对象时间:

Recruiting time:

From2016-09-01To 2016-12-31 

干预措施:

Interventions:

组别:

止血带组

样本量:

50

Group:

tourniquet group

Sample size:

干预措施:

术中止血带

干预措施代码:

Intervention:

tourniquet use during operation

Intervention code:

组别:

非止血带组

样本量:

50

Group:

non-tourniquet group

Sample size:

干预措施:

术中不安置止血带

干预措施代码:

Intervention:

non-tourniquet use during operation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

华西医院 

单位级别:

三甲 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

失血量

指标类型:

主要指标 

Outcome:

blood loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

软组织损伤程度

指标类型:

主要指标 

Outcome:

soft tissue damage

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎性指标

指标类型:

主要指标 

Outcome:

Inflammatory index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨水泥固定强度

指标类型:

主要指标 

Outcome:

bone cement penetration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院时间

指标类型:

次要指标 

Outcome:

hospital stay length

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

关节肿胀

指标类型:

次要指标 

Outcome:

joint swelling

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

关节活动度

指标类型:

次要指标 

Outcome:

range of motion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛VAS评分

指标类型:

次要指标 

Outcome:

pain VAS score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

计算机随机

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

computer random method

盲法:

Blinding:

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):

共享时间:2017年6月;共享方式:网络共享(网址 http://user.qzone.qq.com/51371770/2)

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

time of data share:2017-6;way of data share: internet share (http://user.qzone.qq.com/51371770/2)

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:

原始数据通过卫生行业科研专项数据库收集、保存和传输

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

all original data will be collected, preserved and transmissed using health industry scientific research program.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-08-14
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