今天是:2019-06-17 星期一

骨显微结构-微循环与激素性股骨头坏死相关机制的研究
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注册号:

Registration number:

ChiCTR1800020024 

最近更新日期:

Date of Last Refreshed on:

2019-03-31 

注册时间:

Date of Registration:

2018-12-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

骨显微结构-微循环与激素性股骨头坏死相关机制的研究  

Public title:

The role of bone microstrcture and microcirculation in the pathogenesis and development of glucocorticoid-induced osteonecrosis of the femoral head 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

骨显微结构-微循环与激素性股骨头坏死相关机制的研究  

Scientific title:

The role of bone microstrcture and microcirculation in the pathogenesis and development of glucocorticoid-induced osteonecrosis of the femoral head 

研究课题代号(代码):

Study subject ID:

国家自然基金(81702181),上海浦江人才计划(16PJ1408100) 

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:

李广翼 

研究负责人:

李广翼 

Applicant:

Li Guangyi 

Study leader:

Li Guangyi 

申请注册联系人电话:

Applicant telephone:

+86 15000028837 

研究负责人电话:

Study leader's telephone:

+86 15000028837 

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:

guangyi.li@shsmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

guangyi.li@shsmu.edu.cn 

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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Shanghai, China 

Study leader's address:

600 Yishan Road, Shanghai, 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:

上海市第六人民医院 

Applicant's institution:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital  

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:

2019-KY-006(K) 

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:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Sixth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-28 

伦理委员会联系人:

贾伟平 

Contact Name of the ethic committee:

Jia Weiping 

伦理委员会联系地址:

上海市宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Shanghai, 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:

上海市第六人民医院 

Primary sponsor:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital  

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号 

Primary sponsor's address:

600 Yishan Road, SHanghai, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

国家自然基金(81702181),上海浦江人才计划(16PJ1408100)  

Source(s) of funding:

the National Natural Science Fund of China (81702181), Shanghai Pujiang Talent Program (16PJ1408100)  

研究疾病:

股骨头坏死 

Target disease:

Osteonecrosis of femoral head 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

(1)通过对股骨头临床标本的分析,探索股骨头的整体骨组织显微结构、生物力学特性及微血管分布,设立更有临床指导意义的股骨头分区系统,揭示股骨头坏死塌陷的机制,及不同诱因的股骨头坏死机制是否存在异同。 (2)通过建立激素性股骨头坏死动物模型, 研究坏死不同时期股骨头的整体骨组织显微结构、生物力学特性、微血管分布及骨显微结构-微循环相关细胞因子的影响,验证临床发现。 (3)通过细胞实验与动物实验,研究骨源性微血管内皮细胞凋亡以及血管新生-骨形成耦联与股骨头坏死发生发展之间的关系,在此基础上,进一步探究糖皮质激素-YAP-HIF-1α 信号通路在其中的作用。 

Objectives of Study:

(1)To explore the microstructure, biomechanical characteristic, and distribution of microvessels in femoral head to establish more meaningful partition system and uncover the mechanism of collapse in ONFH. (2)To study the microstructure, biomechanical characteristic, and distribution of microvessels in different stage of ONFH through animal study. (3)To study the relationship between bone-derived vessels and the progress of ONFH, and the role of glucocorticoid-YAP- HIF-1a in the development of ONFH. 

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) 股骨头坏死行全款关节置换手术患者; (2) 股骨颈骨折行全款关节置换手术患者。 

Inclusion criteria

(1) Patients who underwent hip replacement for necrosis of femoral; (2) Patients who underwent hip replacement for fracture of femoral head.  

排除标准:

1)已知的除激素性股骨头坏死外的代谢性或骨相关性疾病,比如肾功能障碍、甲状腺或甲状旁腺疾病、恶性肿瘤等; 2)其他会影响到骨结构和骨质量的疾病,比如类风湿性关节炎等; 3)服用可影响骨代谢的药物,比如抗骨吸收药物、降钙素、甲状腺素、甲状旁腺素和性糖皮质激素替代治疗; 4)髋部截骨手术史。 

Exclusion criteria:

1) known metabolic or bone disorders other than osteonecrosis of femoral head, which could affect bone metabolism, such as severe renal impairment, thyroid or parathyroid disease, and malignancy; 2) other known joint diseases, which could affect bone architecture and quality, such as rheumatoid arthritis, Paget disease, congenital hip dysplasia; 3) receiving treatments that affect bone metabolism such as antiresorptive drugs, calcitonin, thyroid or parathyroid hormone therapy, or hormonal replacement therapy; 4) hip osteotomy history. 

研究实施时间:

Study execute time:

From2019-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

Ctrl group

Sample size:

干预措施:

收集股骨头

干预措施代码:

Intervention:

Collect femoral head

Intervention code:

组别:

激素性股骨头坏死组

样本量:

250

Group:

glucocorticoid-induced osteonecrosis of femoral head

Sample size:

干预措施:

收集股骨头

干预措施代码:

Intervention:

Collect femoral head

Intervention code:

组别:

酒精性股骨头坏死组

样本量:

200

Group:

alcohol-induced osteonecrosis of femoral head

Sample size:

干预措施:

收集股骨头

干预措施代码:

Intervention:

Collect femoral head

Intervention code:

组别:

创伤性股骨头坏死组

样本量:

200

Group:

trauma-induced osteonecrosis of femoral head

Sample size:

干预措施:

收集股骨头

干预措施代码:

Intervention:

Collect femoral head

Intervention code:

组别:

特发性股骨头坏死组

样本量:

200

Group:

idiopathic necrosis of femoral head

Sample size:

干预措施:

收集股骨头

干预措施代码:

Intervention:

Collect femoral head

Intervention code:

组别:

股骨颈骨折组

样本量:

100

Group:

fracture of femoral head

Sample size:

干预措施:

收集股骨头

干预措施代码:

Intervention:

Collect femoral head

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

骨体积分数

指标类型:

主要指标 

Outcome:

BV/TV

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:

股骨头

组织:

Sample Name:

femoral head

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 years
最大 Max age 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):

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

2023年6月1日之后,联系通讯作者获取

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

After June 1st, 2023, contact the correspondence author to obtain the data

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:

数据采集采用自制病例记录表,管理采用EXCEL软件进行管理

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

Data was collected by case record form,and management is based on EXCEL software.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-12-12
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