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股骨颈截骨器在髋关节置换术中的应用
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注册号:

Registration number:

ChiCTR-OOC-15005904 

最近更新日期:

Date of Last Refreshed on:

2015-01-30 

注册时间:

Date of Registration:

2015-01-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

股骨颈截骨器在髋关节置换术中的应用 

Public title:

Femoral Neck Osteotomy Guide for Total Hip Arthroplasty 

研究课题的正式科学名称:

股骨颈截骨器在髋关节置换术中的应用 

Scientific title:

Femoral Neck Osteotomy Guide for Total Hip Arthroplasty 

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:

杨磊 

研究负责人:

张英泽 

Applicant:

Lei Yang 

Study leader:

yingze zhang 

申请注册联系人电话:

Applicant telephone:

+86 18533112939 

研究负责人电话:

Study leader's telephone:

+86 0311 88603610 

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:

13785167116@139.com 

研究负责人电子邮件:

Study leader's E-mail:

dryzzhang@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:

石家庄市桥西区自强路139号 

研究负责人通讯地址:

石家庄市桥西区自强路139号 

Applicant address:

No. 139 Ziqiang Road, Qiaoxi district, Shijiazhuang 

Study leader's address:

No. 139 Ziqiang Road, Qiaoxi district, Shijiazhuang 

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:

河北医科大学第三医院 

Applicant's institution:

The Third Hospital of Hebei Medical 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:

科2012-010-2 

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:

河北医科大学第三医院伦理委员会 

Name of the ethic committee:

The Third Hospital of Hebei Medical University Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

研究实施负责(组长)单位:

张英泽 

Primary sponsor:

yingze zhang 

研究实施负责(组长)单位地址:

河北医科大学第三医院 

Primary sponsor's address:

The Third Hospital of Hebei Medical University 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北省

市(区县):

石家庄市

Country:

China

Province:

Hebei

City:

Shijiazhuang

单位(医院):

河北医科大学第三医院

具体地址:

石家庄市桥西区自强路139号

Institution
hospital:

The Third Hospital of Hebei Medical University

Address:

No. 139 Ziqiang Road, Qiaoxi district, Shijiazhuang

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

无 

Target disease:

no 

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:

Other 

研究目的:

介绍一种用于髋关节置换中辅助股骨颈截骨并减少双下肢不等长发生率的装置,评价其在临床中的应用效果。 

Objectives of Study:

This study introduces a device designed to increase the precision of the femoral neck osteotomy and reduce the incidence of leg length discrepancy, and evlauate its clinical effects. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续病例 

Study design:

Case series 

纳入标准:

纳入标准:需初次行髋关节置换的患者,双下肢长度差<5mm,患者一侧肢体需行髋关节置换,另一侧正常。 

Inclusion criteria

Inclusion criteria were: primary hip arthroplasty with limb-length discrepancy less than 5 mm. In these patients, only one side required hip replacement while the other side was normal. 

排除标准:

排除标准:术前双下肢长度差>5mm,保留颈的髋关节置换术,曾行髋关节置换术病史。具有肥胖,类风湿关节炎,脊柱侧弯,骨盆倾斜,脑血栓、脑瘫等原因引起跛行。 

Exclusion criteria:

Exclusion criteria were: preoperative LLD longer than 5 mm by tape measurement, total hip arthroplasty with femoral neck preservation and a history of previous hip surgery. Patients were also excluded from the study if they had obesity, rheumatoid arthritis, scoliosis, pelvic obliquity, or a limp caused by cerebral thrombosis, cerebral palsy and other causes. 

研究实施时间:

Study execute time:

From2012-12-01To 2013-12-31 

干预措施:

Interventions:

组别:

用截骨器/不用截骨器

样本量:

48

Group:

with formoral neck osteotomy guide/without femoral neck osteotomy guide

Sample size:

干预措施:

截骨器

干预措施代码:

Intervention:

femoral neck osteotomy guide

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

石家庄市 

Country:

China 

Province:

Hebei 

City:

Shijiazhuang 

单位(医院):

河北医科大学第三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Hospital of Hebei Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

截骨高度

指标类型:

主要指标 

Outcome:

osteotomy height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

双下肢长度差

指标类型:

主要指标 

Outcome:

leg length discrepancy

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:

no

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 83 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):

单纯随机抽样

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

simple random sampling

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-01-30
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