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反复短暂缺血促进骨折愈合的临床研究
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注册号:

Registration number:

ChiCTR-INR-17014208 

最近更新日期:

Date of Last Refreshed on:

2017-12-29 

注册时间:

Date of Registration:

2017-12-28 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

反复短暂缺血促进骨折愈合的临床研究 

Public title:

A Clinical Study of Enhancement of fracture healing by Transient Ischemia-reperfusion treatment  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

反复短暂缺血促进骨折愈合的临床研究 

Scientific title:

A Clinical Study of Enhancement of fracture healing by Transient Ischemia-reperfusion treatment  

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:

吕文睿 

研究负责人:

周君琳 

Applicant:

Wenrui LYU 

Study leader:

+86 Junlin ZHOU 

申请注册联系人电话:

Applicant telephone:

+86 13439486903 

研究负责人电话:

Study leader's telephone:

010-85231227 

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:

yu78ren@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fiona4733@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:

北京市朝阳区工体南路8号 

研究负责人通讯地址:

北京市朝阳区工体南路8号 

Applicant address:

8 Gongtinan Road South, Chaoyang District, Beijing, China 

Study leader's address:

8 Gongtinan Road South, Chaoyang District, Beijing, 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:

首都医科大学附属北京朝阳医院 

Applicant's institution:

Capital Medical University affiliated Beijing Chaoyang 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:

2017-5-8-2 

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:

北京朝阳医院伦理委员会 

Name of the ethic committee:

Ethic Committe of Capital Medical University affiliated Beijing Chaoyang Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-05-25 

伦理委员会联系人:

顾老师 

Contact Name of the ethic committee:

Ms.Gu 

伦理委员会联系地址:

北京市朝阳区工体南路8号 

Contact Address of the ethic committee:

8 Gongtinan Road South, Chaoyang District, Beijing, China 

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:

首都医科大学附属北京朝阳医院 

Primary sponsor:

Capital Medical University affiliated Beijing Chaoyang Hospital 

研究实施负责(组长)单位地址:

北京市朝阳区工体南路8号 

Primary sponsor's address:

8 Gongtinan Road South, Chaoyang District, Beijing, 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):

北京

市(区县):

朝阳区

Country:

China

Province:

Beijing

City:

Chaoyang District

单位(医院):

首都医科大学附属北京朝阳医院

具体地址:

北京市朝阳区工体南路8号

Institution
hospital:

Capital Medical University affiliated Beijing Chaoyang Hospital

Address:

8 Gongtinan Road South, Chaoyang District, Beijing, China

经费或物资来源:

北京市科学技术委员会 

Source(s) of funding:

Beijing Municipal Science& Technology Commission 

研究疾病:

肢体骨折 

Target disease:

Limb fracture 

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:

以骨折术后患者为研究对象,采用随机分组,随机分为反复短暂缺血组与对照组,观察术后患肢反复短暂缺血处理对骨折愈合的疗效及其使用的可行性。 

Objectives of Study:

To evaluate the efficacy on fracture healings of repeated ischemia-reperfusion treatment after operation. 

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 年龄18至60岁患者。 ② 新鲜、闭合或者Gustilo I型、II型的四肢非近端骨折。 ③ 采用切开复位内固定或闭合复位内固定术式(术者相同)。 ④ 签署临床研究知情同意书。 

Inclusion criteria

1. Aged 18 to 60 year-old; 2. Diagnosed as Gustilo I/II distal limb fractures; 3. Treated by open reduction or closed reduciton with internal fixation; 4. Have signed informed consent. 

排除标准:

① 病理性骨折患者。 ② 合并其他部位骨折患者。 ③ 合并代谢性和免疫性疾病的患者。 ④ 患肢大腿根部局部皮损,不适合RII的患者。 ⑤ 不配合研究、中途退出和失访的患者。 ⑥ 不符合纳入标准的其他患者。 

Exclusion criteria:

1. Diagnosed as pathological fracture; 2. Accompanied by other fractures; 3. Accompanied by metabolic disease or immune disease; 4. Local skin injury; 5. Patients don't cooperate, quit, or default; 6. Patients don't meet the inclusion criterias. 

研究实施时间:

Study execute time:

From2016-07-01To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2019-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

Trial group

Sample size:

干预措施:

术后予以受试者反复短暂缺血处理

干预措施代码:

Intervention:

Treatment of repeated ischeia-reperfusion after operation.

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

不予以RII处理

干预措施代码:

Intervention:

Without RII treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

朝阳区 

Country:

China 

Province:

Beijing 

City:

Chaoyang 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三级甲等医院 

Institution
hospital:

Capital Medical University affiliated Beijing Chaoyang Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

X线

指标类型:

主要指标 

Outcome:

X-ray photography

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CT 扫描

指标类型:

主要指标 

Outcome:

CT scan

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能评分

指标类型:

次要指标 

Outcome:

Functional scores

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

次要指标 

Outcome:

Visual Simulation Pain Score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细胞因子

指标类型:

次要指标 

Outcome:

Cytokines

Type:

Secondary indicator 

测量时间点:

测量方法:

ELISA

Measure time point of outcome:

Measure method:

ELISA

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

血液

Sample Name:

Blood

Tissue:

blood

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 18 years
最大 Max age 65 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):

由研究人员采取抓阄方式对受试者进行随机分组。

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

The subjects were randomly divided into two groups by casting lots.

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):

试验完成后6个月内公开,于“中国临床试验注册中心网”进行公布

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

The data will be published within 6 months after the trial complete on the website of Chinese Clinical Registry

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:

随访表记录

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-12-28
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