今天是:2020-08-05 星期三

对比Duraloc和Pinnacle髋臼假体在全髋置换术中的生存率:10年以上的中期随访研究
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注册号:

Registration number:

ChiCTR2000034641 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

对比Duraloc和Pinnacle髋臼假体在全髋置换术中的生存率:10年以上的中期随访研究 

Public title:

Comparing the difference of the survival between Duraloc and Pinnacle acetabular component in total hip arthroplasty: a 10 years follow-up study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

对比Duraloc和Pinnacle髋臼假体在全髋置换术中的生存率:10年以上的中期随访研究 

Scientific title:

Comparing the difference of the survival between Duraloc and Pinnacle acetabular component in total hip arthroplasty: a 10 years follow-up study 

研究课题代号(代码):

Study subject ID:

2018HH0141 

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:

曾羿 

研究负责人:

曾羿 

Applicant:

Zeng Yi 

Study leader:

Zeng Yi 

申请注册联系人电话:

Applicant telephone:

+86 18980602289 

研究负责人电话:

Study leader's telephone:

+86 18980602289 

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:

zengyigd@126.com 

研究负责人电子邮件:

Study leader's E-mail:

zengyigd@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号华西医院骨科 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号华西医院骨科 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China  

Study leader's address:

37 Guoxue Lane, Wuhou District, 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 

Applicant's institution:

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 trials and biomedical ethics committee, 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:

孙国荣 

Contact Name of the ethic committee:

Sun Guorong 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号华西医院老八教401 

Contact Address of the ethic committee:

Room 401, 8th Teaching Building, West China Hospital, 37 Guoxuexiang, Chengdu, Sichuan, 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:

四川大学华西医院骨科 

Primary sponsor:

Department of Orthopedics, 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号华西医院骨科  

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):

华西医院

具体地址:

成都市武侯区国学巷37号

Institution
hospital:

West China Hospital

Address:

37 Guoxuexiang, Chengdu

经费或物资来源:

四川省科技厅国际合作与交流项目(2018HH0141) 

Source(s) of funding:

International cooperation and exchange program of sichuan science and technology department (2018HH0141)  

研究疾病:

终末期髋关节疾病 

Target disease:

end-stage hip disease  

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

对在我院行全髋关节置换术的患者进行10年以上的长期随访,根据患者髋臼假体的使用将其分为2个组,研究分析不同组之间患者的临床疗效、影像学结果情况,总结分析最适合临床患者使用的髋臼假体。  

Objectives of Study:

we plan to perform a more thant 10 years follow-up study to investigate the clincial outcomes and radiological findins for patients undergoing total hip arthroplasty with different acetabular implant, Duraloc or Pinnacle, and to demonstreate which implant is the moest suitable for total hip arthroplasty.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1、10年前在我院行全髋关节置换术的患者; 2、使用pinnacle假体或Duraloc假体的患者 

Inclusion criteria

1. patients who underwent total hip arthroplasty more than 10 years ago; 2. patients underwent total hip arthroplasty with Duraloc or Pinnacle acetabular implant.  

排除标准:

1. 接受全髋置换手术,但随访时间不足10年的患者; 2. 使用非Pinnacle或Duraloc假体的患者  

Exclusion criteria:

1. patients who underwent total hip arthroplasty with less than 10 years; 2. patients who underwent total hip arthroplasty with non-Pinnacle or Duraloc implants. 

研究实施时间:

Study execute time:

From2020-07-20To 2020-10-31 

征募观察对象时间:

Recruiting time:

From2020-07-13To 2020-10-31 

干预措施:

Interventions:

组别:

Pinnacle组

样本量:

50

Group:

Pinnacle group

Sample size:

干预措施:

使用Pinnacle臼杯

干预措施代码:

Intervention:

Using Pinnacle acetabular implant

Intervention code:

组别:

Duraloc组

样本量:

50

Group:

Duraloc group

Sample size:

干预措施:

使用Duraloc臼杯

干预措施代码:

Intervention:

Using Duraloc acetabular implant

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:

Chengdu 

单位(医院):

华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

Harris髋关节功能评分

指标类型:

主要指标 

Outcome:

Harris hip function 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:

X线片

指标类型:

主要指标 

Outcome:

X ray examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单能量重建CT

指标类型:

主要指标 

Outcome:

monochromatic energy reconstructed CT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

次要指标 

Outcome:

complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

假体生存率

指标类型:

主要指标 

Outcome:

implant survival rate

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:

影像学资料

组织:

Sample Name:

radiological examination

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 80 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):

非随机

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

N/A

盲法:

N/A

Blinding:

N/A

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):

网络共享(网址 http://user.qzone.qq.com/51371770/2)

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

internet share (http://user.qzone.qq.com/51371770/2)

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:

通过CRF表格进行采集数据并整理

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

all original data will be collected, preserved and transmissed using CRF way

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-07-12
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