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Minimally invasive anterolateral approach versus modified Hardinge approach in arthroplasty for total hip :A prospective randomized study with a medium-term follow-up
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注册号:

Registration number:

ChiCTR2000033322 

最近更新日期:

Date of Last Refreshed on:

2020-05-28 

注册时间:

Date of Registration:

2020-05-28 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

全髋关节置换术中微创前外侧入路与改良 Hardinge 入路的比较:一项中期随访的前瞻性随机研究 

Public title:

Minimally invasive anterolateral approach versus modified Hardinge approach in arthroplasty for total hip :A prospective randomized study with a medium-term follow-up 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全髋关节置换术中微创前外侧入路与改良 Hardinge 入路的比较:一项中期随访的前瞻性随机研究 

Scientific title:

Minimally invasive anterolateral approach versus modified Hardinge approach in arthroplasty for total hip : A prospective randomized study with a medium-term follow-up 

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:

张震祥 

研究负责人:

张震祥 

Applicant:

Zhenxiang Zhang 

Study leader:

Zhenxiang Zhang 

申请注册联系人电话:

Applicant telephone:

+86 21 86532798 

研究负责人电话:

Study leader's telephone:

+86 21 86532798 

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:

Zhenxiangzhang1982@126.com 

研究负责人电子邮件:

Study leader's E-mail:

Zhenxiangzhang1982@126.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:

江苏省泰州市太湖路366号 

研究负责人通讯地址:

江苏省泰州市太湖路366号 

Applicant address:

366 Taihu Road, Taizhou, Jiangsu, China 

Study leader's address:

366 Taihu Road, Taizhou, 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:

江苏省泰州市人民医院 

Applicant's institution:

Taizhou People's Hospital 

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:

泰州市人民医院 

Primary sponsor:

Taizhou People's Hospital 

研究实施负责(组长)单位地址:

江苏省泰州市太湖路366号 

Primary sponsor's address:

366 Taihu Road, Taizhou, 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):

江苏省

市(区县):

泰州市

Country:

China

Province:

Jiangsu

City:

Taizhou

单位(医院):

泰州市人民医院

具体地址:

江苏省泰州市太湖路366号

Institution
hospital:

Taizhou People's Hospital

Address:

366 Taihu Road, Taizhou, Jiangsu

经费或物资来源:

无 

Source(s) of funding:

none 

研究疾病:

全髋关节置换 

Target disease:

THA 

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:

我们目前工作的目的是通过比较一组配对的受试者来解决这些争议,手术方法被认为是唯一的显著变化。本研究比较了 38 例接受 OCM 技术的患者与 39 例接受改良 Hardinge 入路的受试者。两组的其他因素,如疼痛管理、麻醉方法以及物理治疗策略保持相同。我们前瞻性随机 4 年临床研究的假设是,与传统方法相比,OCM 技术将产生更好的临床和影像学结果。 

Objectives of Study:

The purpose of our present work was to solve these controversies via comparing a paired group of subjects and the surgical approach was recognized as the only significant change. The study compared 38 patients receiving OCM technique with 39 subjects receiving modified Hardinge approach. Other factors such as pain management, anesthesia method, as well as physical therapy strategy kept the same for both groups. The hypothesis underlying our present prospective randomized 4-year clinical study was that OCM technique would lead to better clinical and radiological results as compared with conventional approaches. 

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:

入选标准如下:髋关节骨关节炎、股骨头坏死或 Crowe I 型或 II 型发育不良。 

Inclusion criteria

Inclusion criteria were as follows: hip osteoarthritis, femoral head necrosis, or Crowe type I or II dysplasia. 

排除标准:

(1) Crowe III 型或 IV 型发育不良; (2) BMI≥30 kg/m2; (3) 既往植入; (4) 既往髋关节手术; (5) 不愿意参加研究; (6) 符合所有入选标准的受试者通过术前揭盲密封和编号的信封被随机分配到 MH 或 OCM 组。 

Exclusion criteria:

(1) Crowe type III or IV dysplasia; (2) BMI>=30 kg/m2; (3) prior hardware; (4) previous hip operation; (5) unwilling to take part in the research; (6) or subjects fit for all the inclusion criteria were randomly sorted into MH or OCM group by unrevealing the sealed and numbered envelopes before operation. 

研究实施时间:

Study execute time:

From2010-01-01To 2015-01-01 

干预措施:

Interventions:

组别:

OCM组

样本量:

38

Group:

OCM Group

Sample size:

干预措施:

On the 2nd day, 6th week, 1st year and 4th year after operation, the subjects were evaluated.

干预措施代码:

Intervention:

On the 2nd day, 6th week, 1st year and 4th year after operation, the subjects were evaluated.

Intervention code:

组别:

MH组

样本量:

39

Group:

MH Group

Sample size:

干预措施:

On the 2nd day, 6th week, 1st year and 4th year after operation, the subjects were evaluated.

干预措施代码:

Intervention:

On the 2nd day, 6th week, 1st year and 4th year after operation, the subjects were evaluated.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

泰州市 

Country:

China 

Province:

Jiangsu 

City:

Taizhou 

单位(医院):

泰州市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Taizhou people's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

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:

WOMAC评分

指标类型:

主要指标 

Outcome:

WOMAC score

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:

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 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

符合所有入选标准的受试者通过术前揭盲密封和编号的信封被随机分配到 MH 或 OCM 组。(未描述随机方法)

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

subjects fit for all the inclusion criteria were randomly sorted into MH or OCM group by unrevealing the sealed and numbered envelopes before operation.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

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):

Not stated

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

Not stated

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:

数据采集和管理由两部分组成,一为病例记录表,二为电子采集和管理系统

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

Data collection and management consists of two parts, one is case record form and the other is electronic collection and management system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-28
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