今天是:2021-07-24 星期六

灯笼状植骨螺钉治疗早期股骨头坏死的临床研究
下载XML文档

注册号:

Registration number:

ChiCTR-TRC-13004078 

最近更新日期:

Date of Last Refreshed on:

2016-06-25 

注册时间:

Date of Registration:

2013-11-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

灯笼状植骨螺钉治疗早期股骨头坏死的临床研究 

Public title:

Clinical study for the treatment of early femoral head necrosis used by lantern-shaped screw fixation system 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

灯笼状植骨螺钉治疗早期股骨头坏死的临床研究 

Scientific title:

Clinical study for the treatment of early femoral head necrosis used by lantern-shaped screw fixation system 

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:

林达生 

研究负责人:

林达生 

Applicant:

Dasheng Lin 

Study leader:

Dasheng Lin 

申请注册联系人电话:

Applicant telephone:

+86 13859289583 

研究负责人电话:

Study leader's telephone:

+86 13859289583 

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:

mgss17@163.com 

研究负责人电子邮件:

Study leader's E-mail:

mgss17@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:

中国福建省漳州市章华中路269号 

研究负责人通讯地址:

中国福建省漳州市章华中路269号 

Applicant address:

269 Zhanghua Road, Xiangcheng District, Zhangzhou, Fujian, China 

Study leader's address:

269 Zhanghua Road, Xiangcheng District, Zhangzhou, Fujian, China 

申请注册联系人邮政编码:

Applicant postcode:

363000 

研究负责人邮政编码:

Study leader's postcode:

363000 

申请人所在单位:

中国人民解放军第175医院, 厦门大学附属东南医院,全军骨科中心 

Applicant's institution:

The 175th hospital of PLA 

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:

20130315 

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:

解放军第175医院医学伦理委员会 

Name of the ethic committee:

Ethic committee of 175hospital of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-03-15 

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:

中国人民解放军第175医院 

Primary sponsor:

The 175th hospital of PLA 

研究实施负责(组长)单位地址:

中国福建省漳州市章华中路269号 

Primary sponsor's address:

269 Zhanghua Road, Xiangcheng District, Zhangzhou, Fujian, 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):

福建

市(区县):

Country:

China

Province:

Fujian

City:

单位(医院):

中国人民解放军第175医院

具体地址:

中国福建省漳州市章华中路269号

Institution
hospital:

The 175th hospital of PLA

Address:

269 Zhanghua Road, Xiangcheng District, Zhangzhou, Fujian, China

经费或物资来源:

南京军区十二五课题资助 

Source(s) of funding:

Fund of Nanjing Military Region 

研究疾病:

股骨头坏死 

Target disease:

Femoral head necrosis 

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:

I期临床试验 

Study phase:

研究目的:

通过临床观察探讨灯笼状植骨螺钉治疗成年人早期股骨头坏死的疗效. 

Objectives of Study:

To explore the preliminary efficacy on adults patients' early femoral head necrosis treated by lantern-shaped screw fixation device. 

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:

1、年龄18至50岁的成年患者;2、单侧或双侧ARCO(国际骨循环研究学会)分期的I、II期股骨头坏死;3、知情同意并签署了知情同意书。 

Inclusion criteria

1. aged between 18 to 50 years; 2. unilateral or bilateral I and II femoral head necrosis according to the ARCO classification; 3. patients who have signed the informed consent. 

排除标准:

1、50岁以上严重的伴有创伤性关节炎(ARCO Ⅲ and V期)的患者;2、严重全身系统性疾病的患者;3、伴有肿瘤或精神疾患的患者。 

Exclusion criteria:

1. age above 50 years and severe osteoarthritic changes in hip joint (ARCO III and V); 2. patients with general diseases; 3. patients with tumor or psychological diseases. 

研究实施时间:

Study execute time:

From2014-01-01To 2024-12-31 

征募观察对象时间:

Recruiting time:

From2014-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

10

Group:

Intervention group

Sample size:

干预措施:

灯笼状植骨螺钉

干预措施代码:

Intervention:

Lantern-shaped support devices

Intervention code:

组别:

对照组

样本量:

10

Group:

Control group

Sample size:

干预措施:

髓芯减压

干预措施代码:

Intervention:

Core decompression

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

从干预措施结束到患者行髋关节置换或股骨头塌陷的时间

指标类型:

主要指标 

Outcome:

Time from intervention to THA or collapse of femoral head

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前及术后髋关节正位片

指标类型:

主要指标 

Outcome:

Anterior and posterior view of hip joint pre- and post operation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋关节CT

指标类型:

主要指标 

Outcome:

Computed tomography of hip joint

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前及术后髋关节疼痛视觉模拟评分

指标类型:

主要指标 

Outcome:

VAS of hip joint pre- and post operation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术前及术后髋关节功能活动评分

指标类型:

主要指标 

Outcome:

Harris Hip score pre- and post- operation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者性别、手术时年龄及股骨头坏死病因

指标类型:

主要指标 

Outcome:

Gender, age at surgery and etiology of necrosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术时间,出血量,总住院日

指标类型:

次要指标 

Outcome:

Operative duration and blood loss on operation, total days of hospitalization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

灯笼状螺钉治疗早期股骨头坏死的生存率

指标类型:

次要指标 

Outcome:

Survival rate for the treatment of early avascular necrosis of the femoral head

Type:

Secondary 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:

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 50 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):

电脑随机产生。

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

Computer randomized procedure.

盲法:

NA

Blinding:

NA

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):

中国人民解放军第175医院

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

the 175th hospital of PLA

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:

中国人民解放军第175医院

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

the 175th hospital of PLA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-11-28
返回列表