Today is 2021-11-30

The value of dynamic MRI in the treatment of cervical spondylotic myelopathy
download

注册号:

Registration number:

ChiCTR1900023014 

最近更新日期:

Date of Last Refreshed on:

2019-05-07 

注册时间:

Date of Registration:

2019-05-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

张有余医师:该研究的伦理审批文件未上传,请尽快按要求上传(JPG或PDF格式,500KB以内)。 屈伸位MRI在脊髓型颈椎病治疗中的应用价值研究 

Public title:

The value of dynamic MRI in the treatment of cervical spondylotic myelopathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

屈伸位MRI应用于脊髓型颈椎病治疗中的随机对照临床研究  

Scientific title:

The value of dynamic MRI in the treatment of cervical spondylotic myelopathy: a protocol for a randomized clinical tiral 

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:

张有余 

研究负责人:

王少波 

Applicant:

Zhang Youyu 

Study leader:

Wang Shaobo 

申请注册联系人电话:

Applicant telephone:

+86 13146014818 

研究负责人电话:

Study leader's telephone:

+86 15652374179 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

82267368 

申请注册联系人电子邮件:

Applicant E-mail:

1310301525@pku.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xunanfang@foxmail.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:

北京市海淀区学院路38号 

研究负责人通讯地址:

北京市海淀区花园北路 

Applicant address:

38 College Road, Haidian District, Beijing, China 

Study leader's address:

49 Garden Road North, Haidian District, Beijing, 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:

北京大学第三医院 

Applicant's institution:

Peking University Third 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)医伦审第(064-02)号 

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:

北京大学第三医院医学科学研究伦理委员会 

Name of the ethic committee:

Peking University Third Hospial Medical Science Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

洪老师 

Contact Name of the ethic committee:

Teacher Hong 

伦理委员会联系地址:

北京市海淀区花园北路49号 

Contact Address of the ethic committee:

49 Garden Road North, Haidian District, Beijing, 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:

北京大学第三医院 

Primary sponsor:

Peking Universtiy Third Hospital 

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号 

Primary sponsor's address:

49 Garden Road North, Haidian District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学第三医院

具体地址:

海淀区花园北路49号

Institution
hospital:

Peking University Third Hospital

Address:

49 Garden Road North, Haidian District

经费或物资来源:

北京市科技计划课题 

Source(s) of funding:

Beijing Municipal Science and Technology Project  

研究疾病:

脊髓型颈椎病 

Target disease:

cervical spondylotic myelopathy 

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:

探索性研究/预试验 

Study phase:

研究目的:

1.将临床上具备脊髓型颈椎病的患者根据普通MRI影响特征分为三组,每组60例:①硬膜囊部分受压;②硬膜囊完全受压;③脊髓明显受压;通过dMRI评估脊髓压迫程度的加重以及脊髓压迫节段的增加,明确脊髓型颈椎病患者行dMRI检查的适应条件。 2.前瞻性评估dMRI对180例脊髓型颈椎病患者手术方案的影响,并通过随机对照研究和长期随访,比较基于dMRI制定的手术方案对患者神经功能恢复和生活质量改变的影响,以明确脊髓型颈椎病患者行dMRI检查的适应条件,以及dMRI对于指导手术方案选择的意义。 

Objectives of Study:

1.To assess the feasibility of dynamic MRI in the evaluation of CSM and explore the criterion of dynamic MRI for CSM patients. 2.To assess the validation of dynamic MRI in the surgical decision making for CSM patients and find the difference of two surgical plans from dynamic MRI and static MRI, respectively, and surgical effectiveness. 

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.符合脊髓型颈椎病临床诊断; 2.无手术禁忌症; 3.具备手术治疗意愿; 4.同意参加本研究。 

Inclusion criteria

1.Diagnosis of cervical spondylotic myelopathy (CSM); 2.No surgical contraindications; 3.Willing to receive surgery; 4.Willing to take part in our study. 

排除标准:

1.合并颈椎其他疾病(外伤、肿瘤、感染性疾病); 2.年龄小于18岁。 

Exclusion criteria:

1.Other diseases in cervical vertebra (trauma, tumor, infection); 2.Aged < 18 years. 

研究实施时间:

Study execute time:

From2019-09-01To 2021-09-01 

征募观察对象时间:

Recruiting time:

From2019-09-01To 2021-09-01 

干预措施:

Interventions:

组别:

动态MRI

样本量:

90

Group:

dynamic MRI

Sample size:

干预措施:

选择根据dMRI制定的手术方案

干预措施代码:

Intervention:

choose the surgical plan made by dMRI

Intervention code:

组别:

普通MRI

样本量:

90

Group:

normal MRI

Sample size:

干预措施:

选择根据普通MRI制定的手术方案

干预措施代码:

Intervention:

choose the surgical plan made by normal MRI

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第三医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

JOA评分

指标类型:

主要指标 

Outcome:

JOA 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:

MRI脊髓压迫程度

指标类型:

次要指标 

Outcome:

the compression degree on static MRI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36评分

指标类型:

次要指标 

Outcome:

SF-36 score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C2-C7的cobb角

指标类型:

次要指标 

Outcome:

cobb anlge between C2 and C7

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

10-s G&R和10-s step试验

指标类型:

次要指标 

Outcome:

10-s G&R and 10-s step test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核磁T2加权像脊髓内高信号

指标类型:

次要指标 

Outcome:

Intramedullary high-intensity signal (IHIS) on T2-weighted MRI

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:

标本中文名:

组织:

Sample Name:

none

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):

随机数生成器 张有余医师:请补充说明何人产生随机序列。

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

random number system

盲法:

open

Blinding:

open

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

完成后于发表的论文中公开

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

We will share IPD on our paper

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:

病例记录表

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

standard data collection

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-07
return list