桡骨远端骨折手法整复外固定方案的规范化与临床操作的精准化研究

注册号:

Registration number:

ITMCTR2022000102

最近更新日期:

Date of Last Refreshed on:

2022-10-14

注册时间:

Date of Registration:

2022-06-22

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

桡骨远端骨折手法整复外固定方案的规范化与临床操作的精准化研究

Public title:

Study on standardization of manipulative reduction and external fixation of distal radius fractures and accuracy of clinical operation

注册题目简写:

English Acronym:

研究课题的正式科学名称:

桡骨远端骨折手法整复外固定方案的规范化与临床操作的精准化研究

Scientific title:

Study on standardization of manipulative reduction and external fixation of distal radius fractures and accuracy of clinical operation

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2200064669 ; ChiMCTR2200006705

申请注册联系人:

成永忠

研究负责人:

成永忠

Applicant:

Chengyongzhong

Study leader:

Chengyongzhong

申请注册联系人电话:

Applicant telephone:

13810220180

研究负责人电话:

Study leader's telephone:

13810220180

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:

bless518@139.com

研究负责人电子邮件:

Study leader's E-mail:

bless518@139.com

申请单位网址(自愿提供):

Study leader's 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:

北京市朝阳区花家地街6号

研究负责人通讯地址:

北京市朝阳区花家地街6号

Applicant address:

6 Huajiadi st, Chaoyang District, Beijing

Study leader's address:

6 Huajiadi st, Chaoyang District, Beijing

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:

中国中医科学院望京医院

Applicant's institution:

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

WJEC-KT-2022-040-P002

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Wangjing Hospital, Chinese Academy of traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/9/22 0:00:00

伦理委员会联系人:

朱立国

Contact Name of the ethic committee:

Zhu Liguo

伦理委员会联系地址:

北京市朝阳区花家地街6号

Contact Address of the ethic committee:

6 Huajiadi st, Chaoyang District, Beijing

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:

中国中医科学院望京医院

Primary sponsor:

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

研究实施负责(组长)单位地址:

北京市朝阳区花家地街6号

Primary sponsor's address:

6 Huajiadi st, Chaoyang District, Beijing

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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

具体地址:

北京市朝阳区花家地街6号

Institution
hospital:

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

Address:

6 Huajiadi st, Chaoyang District, Beijing

经费或物资来源:

中国中医科学院

Source(s) of funding:

Academy of traditional Chinese Medicine

研究疾病:

桡骨远端骨折

研究疾病代码:

Target disease:

Fracture of distal radius

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

研制桡骨远端骨折手法整复外固定技术方案的临床实践指南、进一步推广手法整复外固定技术方案,为精准化操作和实施提供依据。

Objectives of Study:

To develop a clinical practice guide for the technical scheme of manual reduction and external fixation of distal radius fractures, and further promote the technical scheme of manual reduction and external fixation, so as to provide a basis for accurate operation and implementation.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

符合诊断标准的桡骨远端骨折;年龄18-65岁;受伤致就诊时间﹤2周的闭合性骨折。

Inclusion criteria

Distal radius fractures that meet the diagnostic criteria; Age 18-65; The injury resulted in a closed fracture less than 2 weeks after presentation.

排除标准:

不符合上述纳入标准者。合并神经、血管损伤或腕部既往有病变者。开放性及病理性骨折。合并有严重心脑血管疾病或脏器衰竭不能耐受刺激者或精神病患者。正在接受其它相关治疗,可能影响本研究效应指标观测者。孕妇及哺乳期妇女。

Exclusion criteria:

Those who do not meet the above inclusion criteria. Patients with nerve or vascular injury or previous wrist lesions. Open and pathologic fractures. Patients with severe cardiovascular and cerebrovascular diseases, organ failure and intolerance to stimulation, or psychiatric patients. The participants who were receiving other related treatments may have been affected by this study's effect indicators. Pregnant and lactating women.

研究实施时间:

Study execute time:

From 2021-06-30

To      2024-06-30

征募观察对象时间:

Recruiting time:

From 2022-10-12

To      2024-06-30

干预措施:

Interventions:

组别:

对照组

样本量:

40

Group:

control group

Sample size:

干预措施:

实施医生凭经验的复位与固定方案

干预措施代码:

Intervention:

Implement the reduction and fixation scheme based on doctors' experience

Intervention code:

组别:

试验组

样本量:

40

Group:

Test group

Sample size:

干预措施:

实施临床操作精准复位与固定方案

干预措施代码:

Intervention:

Implementation of precise reduction and fixation scheme for clinical operation

Intervention code:

样本总量 Total sample size : 80

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河南

市(区县):

南阳

Country:

China

Province:

Henan

City:

Nanyang

单位(医院):

中国中医科学院望京医院南阳医院

单位级别:

三甲

Institution/hospital:

Nanyang Orthopedic Hospital

Level of the institution:

Triple A

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

单位级别:

三甲

Institution/hospital:

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

Level of the institution:

Triple A

测量指标:

Outcomes:

指标中文名:

X线评分

指标类型:

主要指标

Outcome:

X-ray score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Mayo腕关节评分

指标类型:

主要指标

Outcome:

Mayo wrist score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Gartland-Werley腕关节评分

指标类型:

主要指标

Outcome:

Gartland-Werley wrist 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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

简单随机,试验者制作写有1和2的纸签各40个。混合后抽取。抽到1是试验组。抽到2是对照组。

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

Simple and random, the subjects made 40 paper labels with 1 and 2 written on them. Extraction after mixing. 1 is the test group. The control group was selected as 2.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

2025年12月公开前数据,发表学术论文。

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

In december2015, the data before publication will be published and academic papers will be published.

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:

用病例记录表完成数据采集,数据管理采用EXcel表管理。

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

The case record form is used to complete the data collection, and the data management adopts the EXCEL form management.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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