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髁限制性假体TC3在全膝关节置换术中应用的随访研究
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注册号:

Registration number:

ChiCTR2000034640 

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:

髁限制性假体TC3在全膝关节置换术中应用的随访研究 

Public title:

Follow-up study on the application of condylar constrained prosthesis TC3 in total knee arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

髁限制性假体TC3在全膝关节置换术中应用的随访研究 

Scientific title:

Follow-up study on the application of condylar constrained prosthesis TC3 in total knee arthroplasty 

研究课题代号(代码):

Study subject ID:

四川大学华西医院专职博士后研发基金 (2018HXBH073) 

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:

许宏 

研究负责人:

周宗科 

Applicant:

Hong Xu 

Study leader:

Zongke Zhou 

申请注册联系人电话:

Applicant telephone:

+86 13208193509 

研究负责人电话:

Study leader's telephone:

+86 13208193509 

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:

1656996477@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zongke@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 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, 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 Branch of West China Hospital of 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:

孙荣国 

Contact Name of the ethic committee:

Rongguo Sun 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号四川大学华西医院老八教四楼412室 

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, 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 

Primary sponsor:

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 

Primary sponsor's address:

37 Guoxue Lane, 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):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Chengdu, Sichuan, China

经费或物资来源:

四川大学华西医院专职博士后研发基金 (2018HXBH073) 

Source(s) of funding:

Post-Doctoral Research Project, West China Hospital, Sichuan Universityy (2018HXBH073) 

研究疾病:

膝关节病 

Target disease:

knee joint 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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

1)PFC Sigma TC3 在复杂初次全膝关节置换术中的应用中长期效果; 2)PFC Sigma TC3 在全膝关节翻修膝术(无菌性松动或感染性失败)中的应用的中长期效果; 3)PFC Sigma TC3 联合垫块在复杂初次及翻修手术中应用的中长期效果。 

Objectives of Study:

1. Medium/long term effects of PFC Sigma TC3 in complex primary total knee arthroplasty; 2. Medium/long term effects of PFC Sigma TC3 in total knee revision arthroplasty (aseptic loosening or failure due to infection); 3. Medium/long term effects of PFC Sigma TC3 combined pad in complex primary and revision 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:

既往于我科使用PFC Sigma TC3行复杂初次或翻修膝关节置换术的患者。 

Inclusion criteria

The patients used PFC Sigma TC3 in our department for complex primary or revision knee arthroplasty. 

排除标准:

失访的患者;拒绝加入本研究的患者 

Exclusion criteria:

Patients lost to follow-up; Patients who refused to participate in the study 

研究实施时间:

Study execute time:

From2020-07-20To 2021-07-30 

征募观察对象时间:

Recruiting time:

From2020-08-01To 2021-06-30 

干预措施:

Interventions:

组别:

A

样本量:

100

Group:

A

Sample size:

干预措施:

初次全膝关节置换术(使用PFC Sigma TC3初次

干预措施代码:

Intervention:

primary TKA (with PFC Sigma TC3)

Intervention code:

组别:

B

样本量:

100

Group:

B

Sample size:

干预措施:

全膝关节翻修术(使用PFC Sigma TC3)

干预措施代码:

Intervention:

revision TKA (with PFC Sigma TC3)

Intervention code:

组别:

C

样本量:

50

Group:

C

Sample size:

干预措施:

全膝关节置换术(初次或翻修,使用PFC Sigma TC3 及垫块)

干预措施代码:

Intervention:

TKA (primary or revision; with with PFC Sigma TC3 and mental pad)

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):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

膝关节功能

指标类型:

主要指标 

Outcome:

knee function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛VAS评分

指标类型:

主要指标 

Outcome:

pain VAS 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:

膝关节评分

指标类型:

主要指标 

Outcome:

Knee 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:

患者满意度评分

指标类型:

主要指标 

Outcome:

Patient satisfaction 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:

生活质量评分

指标类型:

主要指标 

Outcome:

Quality of Life 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:

影像学检查

指标类型:

主要指标 

Outcome:

Imaging examination

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:

尚未开始

Not yet 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):

随访研究,不需随机

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

Follow-up studies were performed without Randomization

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):

2021年7月;中国临床试验注册中心;http://www.chictr.org.cn/edit.aspx?pid=56330&htm=4

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

July 2021; China clinical trial registry; http://www.chictr.org.cn/edit.aspx?pid=56330&htm=4

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:

数据收集:Excel worksheet 数据分析:SPSS 软件等

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

Data collection: Excel worksheet Data analysis: SPSS software

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-12
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