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一种改良的前抽屉试验诊断前交叉韧带断裂
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注册号:

Registration number:

ChiCTR1900022945 

最近更新日期:

Date of Last Refreshed on:

2019-05-04 

注册时间:

Date of Registration:

2019-05-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

一种改良的前抽屉试验诊断前交叉韧带断裂 

Public title:

A modified Anterior Drawer Test for Anterior Cruciate Ligament Ruptures 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

一种改良的前抽屉试验诊断前交叉韧带断裂 

Scientific title:

A modified Anterior Drawer Test for Anterior Cruciate Ligament Ruptures 

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:

黄钢勇 

研究负责人:

黄钢勇 

Applicant:

Gangyong Huang 

Study leader:

Gangyong Huang 

申请注册联系人电话:

Applicant telephone:

+86 15021796086 

研究负责人电话:

Study leader's telephone:

+86 15021796086 

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:

cormierhuang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

cormierhuang@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:

上海市静安区乌鲁木齐中路12号 

研究负责人通讯地址:

上海市静安区乌鲁木齐中路12号 

Applicant address:

12 Wulumuqi Middle Road, Shanghai, China 

Study leader's address:

12 Wulumuqi Middle Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200040 

研究负责人邮政编码:

Study leader's postcode:

200040 

申请人所在单位:

复旦大学附属华山医院 

Applicant's institution:

Huashan Hospital Fudan 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:

2014-046 

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:

复旦大学附属华山医院伦理审查委员会 

Name of the ethic committee:

HIRB Huashan Hospital Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

吴翠云 

Contact Name of the ethic committee:

Cuiyun Wu 

伦理委员会联系地址:

上海市静安区乌鲁木齐中路12号 

Contact Address of the ethic committee:

12 Wulumuqi Middle 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:

复旦大学附属华山医院 

Primary sponsor:

Huashan Hospital Fudan University 

研究实施负责(组长)单位地址:

上海市静安区乌鲁木齐中路12号 

Primary sponsor's address:

12 Wulumuqi Middle Road, 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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华山医院

具体地址:

上海市静安区乌鲁木齐中路12号

Institution
hospital:

Huashan Hospital Fudan University

Address:

12 Wulumuqi Middle Road, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

self funding 

研究疾病:

前交叉韧带断裂 

Target disease:

anterior cruciate ligament rupture 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

比较一种改良的前抽屉试验(MADT)来诊断前交叉韧带断裂,并与三种常规试验进行比较,评价其准确性。 

Objectives of Study:

The objective of this study was to set a modified anterior drawer test (MADT) for the diagnosis of ACL ruptures and evaluate its accuracy in comparison with three conventional tests. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

2015年1月至2017年9月接受单侧关节镜检查,以诊断膝关节损伤和/或疼痛的患者,年龄14-49岁,不限男女。 

Inclusion criteria

The patients scheduled to undergo an unilateral arthroscopic procedure for a diagnosis related to knee injury and/or pain by 2 senior authors from January 2015 to September 2017 were enrolled. 

排除标准:

排除有膝关节手术史、膝关节周围骨折(同侧股骨、胫骨或髌骨骨折)和双侧膝关节疾病的患者。同时排除内侧/外侧副韧带应力试验阳性或多韧带损伤的患者。 

Exclusion criteria:

Patients with a history of knee surgery, fractures around the knee( ipsilateral femur, tibial or patellar fractures), and bilateral knee diseases were excluded. Patients with positive medial/lateral collateral ligament stress test or proved multi-ligamentous injuries were also excluded. 

研究实施时间:

Study execute time:

From2015-01-01To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2015-01-01To 2017-09-30 

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

关节镜手术检查发现

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Arthroscopic examination findings

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

一种改良的前抽屉试验/前抽屉试验/Lachman 试验/轴移试验

Index test:

A modified anterior drawer test/anterior drawer test/Lachman test/pivot shift test

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

前交叉韧带断裂病人

例数:

Sample size:

148

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

patients of anterior cruciate ligament ruptures

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

接受关节镜检查且没有前交叉韧带损伤的病例

例数:

Sample size:

252

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

patients of arthroscopic procedure without anterior cruciate ligament ruptures

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

SPE, SEN, ACC, ROC

指标类型:

主要指标 

Outcome:

SPE, SEN, ACC, ROC

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 14 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):

本研究不需要采用随机方法。

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

No need of randomization in this study.

盲法:

研究者在进行四种体格检查诊断时对磁共振结果进行盲法屏蔽。

Blinding:

The investigators were blinded to the MRI when doing and recording the four physical examinations.

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

是否共享原始数据:

IPD sharing

是Yes

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):

01-01-2020

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

01-01-2020

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:

CRF

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

CRf

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-05-04
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