今天是:2019-06-20 星期四

膝关节外侧盘状半月板与正常外侧半月板损伤术前与术后运动学、动力学指标的差异
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注册号:

Registration number:

ChiCTR1900022548 

最近更新日期:

Date of Last Refreshed on:

2019-04-16 

注册时间:

Date of Registration:

2019-04-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膝关节外侧盘状半月板与正常外侧半月板损伤术前与术后运动学、动力学指标的差异 

Public title:

Kinematic and kinetic differences in knee discoid lateral meniscus injury and normal lateral meniscus injury patients before and after surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膝关节外侧盘状半月板与正常外侧半月板损伤术前与术后运动学、动力学指标的差异 

Scientific title:

Kinematic and kinetic differences in knee discoid lateral meniscus injury and normal lateral meniscus injury patients before and after surgery 

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:

李亚强 

研究负责人:

李亚强 

Applicant:

Yaqiang Li 

Study leader:

Yaqiang Li 

申请注册联系人电话:

Applicant telephone:

+86 18217798552 

研究负责人电话:

Study leader's telephone:

+86 18217798552 

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:

liyaqiang817@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liyaqiang817@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

上海市交通大学 

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:

上海市徐汇区华山路1954号上海交通大学med-x研究院228室  

研究负责人通讯地址:

上海市徐汇区华山路1954号上海交通大学med-x研究院228室  

Applicant address:

Med-X Building 228, 1954 Huashan Road, Xuhui District, Shanghai, China 

Study leader's address:

Med-X Building 228, 1954 Huashan Road, Xuhui District, 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:

上海交通大学医学院附属第九人民医院,数字医学教育部工程研究中心  

Applicant's institution:

The Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Engineering Research Center of Digital Medicine and Clinical Translation 

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:

2019050 

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:

上海交通大学生物医学工程学院伦理委员会 

Name of the ethic committee:

Ethics Committee of the School of Biomedical Engineering, Shanghai Jiao Tong University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-18 

伦理委员会联系人:

顾翔 

Contact Name of the ethic committee:

Xiang Gu 

伦理委员会联系地址:

上海市徐汇区华山路1954号 

Contact Address of the ethic committee:

1954 Huashan Road, Xuhui District, 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:

上海交通大学生物医学工程学院 

Primary sponsor:

Shanghai Jiao Tong University School of Biomedical Engineering  

研究实施负责(组长)单位地址:

上海市徐汇区华山路1954号上海交通大学med-x研究院  

Primary sponsor's address:

Med-X Building, 1954 Huashan Road, Xuhui District, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学生物医学工程学院

具体地址:

徐汇区华山路1954号上海交通大学med-x研究院

Institution
hospital:

Shanghai Jiao Tong University School of Biomedical Engineering

Address:

Med-X Building, 1954 Huashan Road, Xuhui District

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第九人民医院

具体地址:

制造局路639号

Institution
hospital:

Shanghai Ninth People's Hospital

Address:

639 Zhizaoju Road

经费或物资来源:

上海交通大学生物医学工程学院 

Source(s) of funding:

Shanghai Jiao Tong University School of Biomedical Engineering  

研究疾病:

外侧盘状半月板 

Target disease:

discoid lateral meniscus 

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:

N/A 

研究目的:

研究膝关节外侧盘状半月板与正常外侧半月板损伤术前与术后运动学、动力学指标的差异 

Objectives of Study:

To study the differences of kinematic and kinetic parameters in the lateral discoid meniscus and the normal lateral meniscus injury patients before and after surgery 

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:

患者临床诊断为膝关节外侧半月板损伤或外侧盘状半月板损伤 

Inclusion criteria

The patient's clinical diagnosis was lateral knee meniscus injury or lateral discoid meniscus injury 

排除标准:

患者存在膝关节周围韧带损伤,软骨损伤,合并内侧半月板损伤,影像学检查患者膝关节无关节炎早期症状,患者合并其他疾病导致的膝关节运动功能障碍 

Exclusion criteria:

The patient had ligament injury around the knee joint, cartilage damage, combined with medial meniscus injury, imaging examination of patients with early symptoms of knee joint without arthritis, and patients with knee joint motor dysfunction caused by other diseases 

研究实施时间:

Study execute time:

From2019-04-15To 2020-05-15 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

正常行走状态下试验

干预措施代码:

Intervention:

self-selected walking trial

Intervention code:

组别:

正常外侧半月板损伤组

样本量:

20

Group:

lateral meniscus injury

Sample size:

干预措施:

自我舒适行走速度试验

干预措施代码:

Intervention:

self-selected walking trial

Intervention code:

组别:

外侧盘状半月板损伤组

样本量:

20

Group:

lateral discoid meniscus injury

Sample size:

干预措施:

自我舒适行走速度试验

干预措施代码:

Intervention:

self-selected walking trial

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 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市交通大学附属第九人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Ninth People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

髋关节运动学、动力学相关指标

指标类型:

主要指标 

Outcome:

kinematic and kinetic parameters of hip joint

Type:

Primary indicator 

测量时间点:

术前,术后3个月,6个月,1年

测量方法:

三维步态分析

Measure time point of outcome:

before surgery and 3 months, 6 months and 1 year after surgery

Measure method:

gait analysis

指标中文名:

膝关节运动学、动力学相关指标

指标类型:

主要指标 

Outcome:

kinematic and kinetic parameters of knee joint

Type:

Primary indicator 

测量时间点:

术前,术后3个月,6个月,1年

测量方法:

三维步态分析

Measure time point of outcome:

before surgery and 3 months, 6 months and 1 year after surgery

Measure method:

gait analysis

指标中文名:

踝关节运动学、动力学相关指标

指标类型:

主要指标 

Outcome:

kinematic and kinetic parameters of ankle joint

Type:

Primary indicator 

测量时间点:

术前,术后3个月,6个月,1年

测量方法:

三维步态分析

Measure time point of outcome:

before surgery and 3 months, 6 months and 1 year after surgery

Measure method:

gait analysis

指标中文名:

步态时空参数

指标类型:

次要指标 

Outcome:

spatiotemporal parameters

Type:

Secondary indicator 

测量时间点:

术前,术后3个月,6个月,1年

测量方法:

三维步态分析

Measure time point of outcome:

before surgery and 3 months, 6 months and 1 year after surgery

Measure method:

gait analysis

指标中文名:

地返力指标

指标类型:

次要指标 

Outcome:

ground force index

Type:

Secondary indicator 

测量时间点:

术前,术后3个月,6个月,1年

测量方法:

三维步态分析

Measure time point of outcome:

before surgery and 3 months, 6 months and 1 year after surgery

Measure method:

gait analysis

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

其它 

说明

Fate of sample:

Others 

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 20 years
最大 Max age 45 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):

No

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):

实验结束后6个月将数据发布于Revman : http://www.medresman.org/login.aspx

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

The data will be published 6 months after accomplishing the experiment via Resman: http://www.medresman.org/login.aspx

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:

数据保存于临床试验公共平台ResMan

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

Data will be saved via ResMan.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-04-16
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