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3D打印技术治疗复杂骨折的可行性:以远端桡骨骨折为例
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注册号:

Registration number:

ChiCTR-IPR-17011343 

最近更新日期:

Date of Last Refreshed on:

2017-05-10 

注册时间:

Date of Registration:

2017-05-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

3D打印技术治疗复杂骨折的可行性:以远端桡骨骨折为例 

Public title:

The feasibility of using 3D printing to treat complex fractures: distal radius fractures as an example 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

3D打印技术在复杂骨折中的应用研究 

Scientific title:

Application of 3D Printing Technique in Complex Fracture 

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:

陈华 

研究负责人:

陈华 

Applicant:

Chen Hua 

Study leader:

Chen Hua 

申请注册联系人电话:

Applicant telephone:

+86 15088556021 

研究负责人电话:

Study leader's telephone:

+86 15088556021 

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:

chenhua_fey@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenhua_fey@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:

浙江省温州市鹿城区学院西路109号 

研究负责人通讯地址:

浙江省温州市鹿城区学院西路109号 

Applicant address:

109 West Xueyuan Road, Lucheng District, Wenzhou, Zhejiang, China  

Study leader's address:

109 West Xueyuan Road, Lucheng District, Wenzhou, Zhejiang, 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:

温州医科大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Wenzhou 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:

浙江省温州医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Wenzhou Medical University  

研究实施负责(组长)单位地址:

浙江省温州市鹿城区学院西路109号 

Primary sponsor's address:

109 West Xueyuan Road, Lucheng District, Wenzhou, Zhejiang, 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):

浙江省

市(区县):

温州市

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

浙江省温州医科大学附属第二医院

具体地址:

浙江省温州市鹿城区学院西路109号

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University

Address:

109 West Xueyuan Road , Lucheng District, Wenzhou, Zhejiang, China.

经费或物资来源:

国家自然科学基金(81472146) 

Source(s) of funding:

the National Natural Science Foundation of China (81472146) 

研究疾病:

复杂骨折 

Target disease:

Complex 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:

探索性研究/预试验 

Study phase:

研究目的:

以桡骨远端骨折为例,研究3D打印技术在复杂骨折治疗中的应用。 

Objectives of Study:

In our research, we took distal radius fracture as an example to evaluate the feasibility of using 3D printing to treat fracture. 

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:

C型桡骨远端骨折;患者及家属同意参与该实验,并能按时随访1年以上; 

Inclusion criteria

C-type distal radius fractures; Patients and their families agreed to participate in the experiment, and can be followed up for more than 1 year; 

排除标准:

神经和血管损伤感染多发性创伤开放性骨折 

Exclusion criteria:

nervous and vascular injuries, infection, multiple trauma, open fractures. 

研究实施时间:

Study execute time:

From2017-08-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2017-08-01To 2018-08-01 

干预措施:

Interventions:

组别:

3D打印组

样本量:

23

Group:

3D printing group

Sample size:

干预措施:

使用3D打印技术

干预措施代码:

Intervention:

Use 3D printing

Intervention code:

组别:

非3D打印组

样本量:

25

Group:

no 3D printing group

Sample size:

干预措施:

不使用3D打印技术

干预措施代码:

Intervention:

not use 3D printing

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

浙江省温州医科大学附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Wenzhou Medical University.  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中出血量

指标类型:

主要指标 

Outcome:

operation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中透视量

指标类型:

主要指标 

Outcome:

Frequency of intraoperative fluoroscopy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腕关节功能评分

指标类型:

次要指标 

Outcome:

Gartland-Werley 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:

术后影像学参数

指标类型:

主要指标 

Outcome:

radiological condition

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:

组织:

Sample Name:

nothing

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 18 years
最大 Max age 75 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):

本研究团队中一名不参与治疗及康复的骨科医师,采用随机数字表法的方式随机将病人分组。

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

The fourth author of this report, who was not involved in clinical treatment, tossed a coin to assign patients to one of the two groups.

盲法:

单盲:主刀医师了解分组,术前需利用3D模型进行计划,无法进行盲法;手术时间、术中出血量、术后功能评价以及影像学指标由另外不了解分组的医师完成

Blinding:

Single-blind: the surgeon to understand the group, preoperative need to use the 3D model to plan, can not blind; surgery time, intraoperative blood loss, postoperative function evaluation and imaging indicators by the other group of doctors do not understand

是否共享原始数据:

IPD sharing

否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):

论文发表见刊后,可邮箱传递

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

Paper published in the journal, can be delivered by mail

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:

数据采用Excel数据保存,SPSS 19.0 进行数据统计

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

The data were saved by Excel and analyzed by SPSS19.0

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:

 2017-05-09
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