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非止血带下全膝关节置换术后加压对下肢肿胀和早期关节功能的影响:随机对照试验
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注册号:

Registration number:

ChiCTR-INR-16010177 

最近更新日期:

Date of Last Refreshed on:

2018-05-08 

注册时间:

Date of Registration:

2016-12-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

非止血带下全膝关节置换术后加压对下肢肿胀和早期关节功能的影响:随机对照试验 

Public title:

Effects of postoperative compression on swelling and early knee function in total knee arthroplasty without tourniquet: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

非止血带下全膝关节置换术后加压对下肢肿胀和早期关节功能的影响:随机对照试验 

Scientific title:

Effects of postoperative compression on swelling and early knee function in total knee arthroplasty without tourniquet: a randomized controlled trial 

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:

于浩达 

研究负责人:

周宗科 

Applicant:

Yu Haoda 

Study leader:

Zhou Zongke 

申请注册联系人电话:

Applicant telephone:

+86 18200271768 

研究负责人电话:

Study leader's telephone:

+86 18980601028 

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:

westchinayu@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zongke@126.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 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院骨科 

Applicant's institution:

Department of Orthopaedics, 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 Research and Biomedical Ethical Committee of West China hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-01-07 

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 Orthopaedics, 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 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China hospital, Sichuan University

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

卫生部行业科研专项基金 

Source(s) of funding:

Ministry of Health Special Scientific Research Projects of China 

研究疾病:

膝关节骨关节炎 

Target disease:

Knee osteoartritis 

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:

比较非止血带下全膝关节置换术后伤口加压与否对肿胀和早期膝关节功能的影响 

Objectives of Study:

For knee osteoarthritis patients who need total knee arthroplasty, this study will be performed to evaluate the effects of postoperative compression on swelling and early knee function in total knee arthroplasty without tourniquet. 

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:

1、初次、单侧全膝关节置换术;2、膝关节骨关节炎患者;3、能够并愿意签署知情同意书 

Inclusion criteria

1. Primary unilateral total knee artropasty; 2. Patients diagnosed with knee osteoartritis; 3. To be able to and willing to provide signed informed consent.  

排除标准:

1. 双膝关节一期手术或膝关节翻修术;2. 膝关节既往手术史;3. 外周血管疾病 abpi<0.8;4. 外周神经病;5. 血凝障碍性疾病;6. 下肢深静脉血栓病史;7.BMI>35;8.僵硬膝 

Exclusion criteria:

1. Simultaneously bilateral total knee arthroplasty or revision case; 2. Surgical History of the knee joint; 3. peripheral vascular disease, abpi<0.8; 4. periphera neuropathy; 5. Blood coagulation disorders; 6. History of deep venous thrombosis; 7. BMI>35 8. knee stiffness 

研究实施时间:

Study execute time:

From2016-12-17To 2018-05-31 

征募观察对象时间:

Recruiting time:

From2016-12-17To 2018-05-31 

干预措施:

Interventions:

组别:

A

样本量:

45

Group:

A

Sample size:

干预措施:

加压包扎

干预措施代码:

Intervention:

compression therapy

Intervention code:

组别:

B

样本量:

45

Group:

B

Sample size:

干预措施:

非加压包扎

干预措施代码:

Intervention:

non-compression therapy

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:

 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China hospital, Sichuan University  

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:

输血量

指标类型:

主要指标 

Outcome:

Blood transfusion volume

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

输血率

指标类型:

主要指标 

Outcome:

Blood transfusion cases

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

主要指标 

Outcome:

Hb

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞压积

指标类型:

主要指标 

Outcome:

Hct

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:

主要指标 

Outcome:

Length of hospital stay

Type:

Primary 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:

主要指标 

Outcome:

Range of motion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节评分

指标类型:

主要指标 

Outcome:

HSS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟疼痛评分

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下肢肿胀

指标类型:

主要指标 

Outcome:

swelling

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

下肢深静脉血栓

指标类型:

主要指标 

Outcome:

DVT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体质量指数

指标类型:

主要指标 

Outcome:

BMI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伤口表面感染率

指标类型:

主要指标 

Outcome:

Superficial infection cases

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

深部感染率

指标类型:

主要指标 

Outcome:

Deep infection cases

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Superficial hematoma

指标类型:

主要指标 

Outcome:

伤口浅表血肿

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伤口浅表瘀斑

指标类型:

主要指标 

Outcome:

Ecchymosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

表面张力小泡

指标类型:

主要指标 

Outcome:

Tension vesicle

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠质量

指标类型:

主要指标 

Outcome:

sleeping quality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节功能评分

指标类型:

主要指标 

Outcome:

knee function score

Type:

Primary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

临床研究助理使用电脑产生随机数

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

The clinical research assistant use the computer to generate the random number

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

EXCEL表, 2017年6月30日

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

EXCEL dataset,by June 30, 2017

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:

EXCEL表

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

EXCEL dataset

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-12-18
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