今天是:2020-07-05 星期日

蒋世杰医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 多种止血带使用方法对膝关节置换术后不同结局指标影响的比较
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注册号:

Registration number:

ChiCTR2000033354 

最近更新日期:

Date of Last Refreshed on:

2020-05-29 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

蒋世杰医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 多种止血带使用方法对膝关节置换术后不同结局指标影响的比较 

Public title:

Comparison of the effects of different tourniquet methods on different outcome indexes after total knee arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多种止血带使用方法对膝关节置换术后不同结局指标影响的比较 

Scientific title:

Comparison of the effects of different tourniquet methods on different outcome indexes after total knee arthroplasty 

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:

蒋世杰 

研究负责人:

王禹基 

Applicant:

Jiang Shijie 

Study leader:

Wang Yuji 

申请注册联系人电话:

Applicant telephone:

+86 13515259128 

研究负责人电话:

Study leader's telephone:

+86 13775221377 

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:

jsjgsl@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13775221377@139.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:

常州市兴隆巷29号 

研究负责人通讯地址:

常州市兴隆巷29号 

Applicant address:

29 Xinglong Lane, Changzhou, Jiangsu, China 

Study leader's address:

29 Xinglong Lane, Changzhou, Jiangsu, 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:

南京医科大学附属常州第二人民医院骨科 

Applicant's institution:

Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

南京医科大学附属常州第二人民医院骨科 

Primary sponsor:

Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University 

研究实施负责(组长)单位地址:

常州市兴隆巷29号 

Primary sponsor's address:

29 Xinglong Lane, Changzhou, Jiangsu, 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):

江苏

市(区县):

常州

Country:

China

Province:

Jiangsu

City:

Changzhou

单位(医院):

南京医科大学附属常州第二人民医院骨科

具体地址:

兴隆巷29号

Institution
hospital:

Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University

Address:

29 Xinglong Lane

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

膝关节骨关节炎 

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:

探索性研究/预试验 

Study phase:

研究目的:

通过前瞻性随机对照研究弹性止血带与空气止血带在高压和低压模式下,观察全膝关节置换术后病人的大腿肿胀情况,局部皮肤情况,术后引流量,膝关节活动度,以及LDH及cpk的变化;本课题的目标是为临床使用止血带找到最佳方案提供理论依据。 

Objectives of Study:

A prospective randomized controlled study of elastic tourniquet and air tourniquet under high pressure and low pressure mode was conducted to observe the changes of thigh swelling, local skin condition, postoperative drainage volume, knee joint mobility, and LDH and CPK after total knee replacement.The objective of this study is to provide a theoretical basis for finding the optimal scheme for the clinical use of 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:

纳入标准为各种膝关节非感染性终末期疾病行单侧膝关节置换的患者。 

Inclusion criteria

The inclusion criteria were patients who underwent unilateral knee replacement for a variety of non-infectious end-stage knee diseases. 

排除标准:

排除标准为膝关节翻修手术的患者,感染性膝关节疾病的患者,有过股骨远端和胫骨近端骨折的患者,有严重下肢静脉曲张的患者。 

Exclusion criteria:

The exclusion criteria were patients undergoing revision knee surgery, patients with infectious knee disease, patients with fractures of the distal femur and proximal tibia, and patients with severe varicose veins in the lower extremities. 

研究实施时间:

Study execute time:

From2020-06-01To 2021-06-01 

干预措施:

Interventions:

组别:

Group 1 vs. Group 2 vs. Group 3

样本量:

45

Group:

Group 1 vs. Group 2 vs. Group 3

Sample size:

干预措施:

弹力止血带vs空气止血带低压模式vs空气止血带高压模式

干预措施代码:

Intervention:

Elastic tourniquet vs. air tourniquet under high pressure and low pressure mode

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

常州 

Country:

China 

Province:

Jiang Su 

City:

Changzhou 

单位(医院):

南京医科大学附属常州第二人民医院骨科 

单位级别:

三级甲等 

Institution
hospital:

Department of Orthopedics, Changzhou No.2 People's Hospital, the Affiliated Hospital of Nanjing Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

大腿周径

指标类型:

主要指标 

Outcome:

Thigh circumference

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:

hemoglobin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳酸脱氢酶

指标类型:

主要指标 

Outcome:

Lactate dehydrogenase

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酸磷酸激酶

指标类型:

主要指标 

Outcome:

creatine phosphokinase

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

引流量

指标类型:

主要指标 

Outcome:

drainage

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节活动度

指标类型:

主要指标 

Outcome:

Knee range of motion

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 45 years
最大 Max age 85 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):

随机数字表

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

random number table

盲法:

未说明

Blinding:

Not stated

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):

百度网盘

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

Baidu Netdisk

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-29
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