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前交叉韧带重建:经胫骨隧道方式VS前内入路
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注册号:

Registration number:

ChiCTR1800014874 

最近更新日期:

Date of Last Refreshed on:

2018-02-12 

注册时间:

Date of Registration:

2018-02-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

前交叉韧带重建:经胫骨隧道方式VS前内入路 

Public title:

Anterior cruciate ligament reconstruction: Transtibial method versus anteromedial portal approach 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

前交叉韧带重建:经胫骨隧道方式VS前内入路 

Scientific title:

Anterior cruciate ligament reconstruction: Transtibial method versus anteromedial portal approach 

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:

盖鹏宙 

研究负责人:

盖鹏宙 

Applicant:

Pengzhou Gai 

Study leader:

Pengzhou Gai 

申请注册联系人电话:

Applicant telephone:

+86 18363800558 

研究负责人电话:

Study leader's telephone:

+86 18363800558 

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:

shankun5211314@163.com 

研究负责人电子邮件:

Study leader's E-mail:

shankun5211314@163.cm 

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:

烟台市南通路26号 

研究负责人通讯地址:

烟台市南通路26号 

Applicant address:

26 Nantong Road, Yantai, Shandong, China  

Study leader's address:

26 Nantong Road, Yantai, Shandong, 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:

毓璜顶医院 

Applicant's institution:

Yuhuangding 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:

2014072606 

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:

毓璜顶医院伦理委员会 

Name of the ethic committee:

Yuhuangding Hospital 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:

王林 

Contact Name of the ethic committee:

Lin Wang 

伦理委员会联系地址:

烟台市芝罘区毓东路20号 

Contact Address of the ethic committee:

20 Yudong Road, Zhifu District, Yantai, Shandong, 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:

毓璜顶医院 

Primary sponsor:

Yuhuangding Hospital  

研究实施负责(组长)单位地址:

烟台市芝罘区毓东路20号 

Primary sponsor's address:

20 Yudong Road, Zhifu District, Yantai, Shandong, 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):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

毓璜顶医院

具体地址:

烟台市芝罘区毓东路20号

Institution
hospital:

Yuhuangding Hospital

Address:

20 Yudong Road, Zhifu District, Yantai, Shandong, China

经费或物资来源:

科室内部科研经费 

Source(s) of funding:

Research funding is provided by our sports medcine department  

研究疾病:

前交叉韧带撕裂 

Target disease:

Anterior cruciate ligament avulsion  

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:

其它 

Study phase:

N/A 

研究目的:

前交叉韧带重建时,AMP方法和TT方法在手术技术和临床结果方面,哪一种更具优越性,一直存在争议。因此,我们的研究是为了检测AMP方法和TT方法在股骨隧道长度和位置方面有无差异,并且这种差异与临床功能和膝关节稳定性是否有关联。  

Objectives of Study:

Controversy continues as to whether the AMP or TT method is superior for ACL reconstruction in terms of both technique and clinical outcome. Our study is to determine if the AMP approach results in a difference of femoral tunnel length and location compared to the transtibial method, and if this correlates with a difference in terms of the clinical function and knee joint stability.  

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:

随访至少1年,正常的对侧膝关节,无严重的术后并发症,例如感染或骨折,必须有术后3D-CT影像学资料。  

Inclusion criteria

At least 1 year post-operative follow up, normal contralateral knee joint, no serious postoperative complications such as infection, no fracture, and must have postoperative CT-based three-dimensional reconstruction imaging data.  

排除标准:

伴有后交叉韧带损伤,伴有侧副韧带损伤,骨关节炎和翻修手术。 

Exclusion criteria:

Complicated with anterior and posterior cruciate ligament injury, complicated with collateral ligament injury, osteoarthritis and revision surgery.  

研究实施时间:

Study execute time:

From2014-06-01To 2088-06-01 

征募观察对象时间:

Recruiting time:

From2014-08-01To 2015-07-01 

干预措施:

Interventions:

组别:

前内入路组

样本量:

60

Group:

Anteromedial portal group

Sample size:

干预措施:

经前内入路方法重建前交叉韧带

干预措施代码:

Intervention:

Anterior cruciate ligament is reconstructed by anteromedial portal.

Intervention code:

组别:

经胫骨隧道组

样本量:

60

Group:

Transtibial group

Sample size:

干预措施:

经胫骨隧道方法重建前交叉韧带。

干预措施代码:

Intervention:

Anterior cruciate ligament is reconstructed by transtibial group。

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

shandong 

City:

 

单位(医院):

毓璜顶医院 

单位级别:

三甲 

Institution
hospital:

Yuhuangding Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

Lysholm 评分

指标类型:

次要指标 

Outcome:

Lysholm 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:

Tegner 评分

指标类型:

次要指标 

Outcome:

Tegner 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:

IKDC 评分

指标类型:

次要指标 

Outcome:

IKDC 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:

轴移实验

指标类型:

次要指标 

Outcome:

Pivot-shift 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:

前抽屉实验

指标类型:

次要指标 

Outcome:

Lanchmann 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:

KT-1000

指标类型:

次要指标 

Outcome:

LT-1000

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

隧道长度

指标类型:

次要指标 

Outcome:

tunnel length

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

隧道位置

指标类型:

主要指标 

Outcome:

tunnel location

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 11 years
最大 Max age 65 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):

盖鹏宙教授使用随机数字表进行随机化处理,偶数被分为前内入路组,奇数被分为经胫骨隧道组。

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

Randomisation was performed by professor Pengzhou Gai according to a random number table, with even numbers in the anteromedial portal group and odd numbers in the transtibial method group.

盲法:

Blinding:

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):

文章发表后6个月内公开原始数据,可向负责人有偿索取原始数据。

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

Six months after the article was published, we will share IPD. People can ask the responsible person for the original data by paying.

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和EDC

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

CRF and EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-02-12
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