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DAA与后外侧入路行人工全髋关节置换术疗效的随机对照研究
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注册号:

Registration number:

ChiCTR1800019816 

最近更新日期:

Date of Last Refreshed on:

2018-11-30 

注册时间:

Date of Registration:

2018-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

DAA与后外侧入路行人工全髋关节置换术疗效的随机对照研究 

Public title:

A randomized controlled trial for the efficacy of total hip arthroplasty with DAA or posterior lateral approach 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

DAA与后外侧入路行人工全髋关节置换术疗效的随机对照研究 

Scientific title:

A randomized controlled trial for the efficacy of total hip arthroplasty with DAA or posterior lateral approach 

研究课题代号(代码):

Study subject ID:

1.江苏省青年医学人才项目(QNRC20168002. 徐州市科技计划项目 (KC16SL111) 3.江苏省卫生计生委面上项目(H2017081)  

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:

冯硕 

研究负责人:

查国春 

Applicant:

Shuo Feng 

Study leader:

Guo-Chun Zha 

申请注册联系人电话:

Applicant telephone:

+86 18552880088 

研究负责人电话:

Study leader's telephone:

+86 17712136030 

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:

781733181@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

41049015@qq.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:

江苏省徐州市泉山区淮海西路99号徐州医科大学附属医院  

研究负责人通讯地址:

江苏省徐州市泉山区淮海西路99号 

Applicant address:

99 Huaihai Road West, Xuzhou, Jiangsu, China 

Study leader's address:

99 Huaihai Road West, Xuzhou, Jiangsu, 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:

徐州医科大学附属医院 

Applicant's institution:

Affiliated Hospital of Xuzhou Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

徐州医科大学附属医院 

Primary sponsor:

Affiliated Hospital of Xuzhou Medical University 

研究实施负责(组长)单位地址:

江苏省徐州市泉山区淮海西路99号 

Primary sponsor's address:

99 Huaihai Road West, Xuzhou, Jiangsu, 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):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州医科大学附属医院

具体地址:

江苏省徐州市泉山区淮海西路99号

Institution
hospital:

Affiliated Hospital of Xuzhou Medical University

Address:

99 Huaihai Road West, Xuzhou, Jiangsu, China

经费或物资来源:

1.江苏省青年医学人才项目(编号:QNRC20168002. 徐州市科技计划项目 (编号:KC16SL111) 3.江苏省卫生计生委面上项目(编号:H2017081)  

Source(s) of funding:

Jiangsu Provincial Medical Youth Talent (QNRC2016802), the Science and Technology Planning Project of Xuzhou (KC16SL111), Foundation of Jiangsu Province commission of Health and Family Planning (H201 

研究疾病:

髋关节疾病 

Target disease:

Hip disease 

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:

对于DAA 入路与传统后外侧入路行人工全髋关节置换术(total hip arthroplasty,THA)的比较研究。 

Objectives of Study:

To evaluate the effectiveness of DAA approach in total hip arthroplasty (THA) compared with conventional posterior lateral approach.  

药物成份或治疗方案详述:

将拟行初次双侧THA 的髋关节疾病患者纳入研究,双侧髋随机分别采用DAA 入路(DAA 组)及传统后外侧入路(对照组)进行关节置换。记两组手术时间、切口长度以及手术相关并发症发生情况;记录比较患者髋关节活动度(屈曲角、外展、髋节功能 Harris 评分、疼痛视觉模拟评分;观察假体位置及术后步态分析等资料的不同。 

Description for medicine or protocol of treatment in detail:

Patients with hip joint disease who were scheduled for initial bilateral THA were enrolled in the study. The hips were randomly assigned to the DAA approach (DAA group) and the conventional posterior lateral approach (control group) for joint replacement. The operation time, length of hospital stay, length of incision, and operation-related complications occurred in the hip group. The hip joint mobility (buckling angle, abduction, hip function Harris score, pain visual analog score) was observed. The position of the prosthesis was observed. Postoperative gait analysis and other data are different. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

初次双侧THA、髋关节骨关节炎、股骨头缺血性坏死,DDH、患者均知情同意、签署手术知情同意书及参与临床研究的协议书。 

Inclusion criteria

Initial bilateral THA, hip osteoarthritis, avascular necrosis of the femoral head, DDH, informed consent, signed informed consent, and participation in clinical studies. 

排除标准:

严重内科疾病合并症、髋关节解剖畸形严重患者、有髋关节感染病史、同侧下肢畸形者、同侧其他关节有疾病者、对步态或负重造成不良影响的神经或骨骼肌肉疾病。 

Exclusion criteria:

Patients with severe medical disease comorbidities, severe hip anatomical deformity, history of hip infection, ipsilateral lower extremity malformation, ipsilateral joint disease, spinal disease, adverse effects on gait or weight Muscle disease. 

研究实施时间:

Study execute time:

From2018-11-30To 2019-11-29 

征募观察对象时间:

Recruiting time:

From2018-11-30To 2019-11-30 

干预措施:

Interventions:

组别:

DAA组

样本量:

25

Group:

DAA group

Sample size:

干预措施:

DAA入路

干预措施代码:

Intervention:

DAA approach

Intervention code:

组别:

传统组

样本量:

25

Group:

control group

Sample size:

干预措施:

后外侧入路

干预措施代码:

Intervention:

conventional posterior lateral approach

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

切口长度

指标类型:

主要指标 

Outcome:

incision length

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中出血量

指标类型:

主要指标 

Outcome:

Intraoperative blood loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

引流量

指标类型:

主要指标 

Outcome:

Drainage

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛VAS评分

指标类型:

主要指标 

Outcome:

pain VAS 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:

HARRIS 评分

指标类型:

主要指标 

Outcome:

HARRIS 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:

步态分析参数

指标类型:

主要指标 

Outcome:

Gait analysis parameters

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

假体位置

指标类型:

主要指标 

Outcome:

Prosthesis position

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度VAS

指标类型:

主要指标 

Outcome:

Satisfaction VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

主要指标 

Outcome:

complication

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 90 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):

通过统计软件SPSS 19.0产生随机数

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

produce Random number table By statistic software SPSS19.0

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

论文发表

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

Paper publication

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:

徐州医科大学附属医院病历系统

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

Affiliated Hospital of Xuzhou Medical University Medical Record System

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:

 2018-11-30
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