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评价骨科手术导航定位系统辅助膝关节置换术的有效性和安全性临床试验
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注册号:

Registration number:

ChiCTR2000036235 

最近更新日期:

Date of Last Refreshed on:

2020-09-06 

注册时间:

Date of Registration:

2020-08-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价骨科手术导航定位系统辅助膝关节置换术的有效性和安全性临床试验 

Public title:

To evaluate the efficacy and safety of orthopedic surgical navigation and positioning system assisted knee replacement clinical trials 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价骨科手术导航定位系统辅助膝关节置换术的有效性和安全性临床试验 

Scientific title:

To evaluate the efficacy and safety of orthopedic surgical navigation and positioning system assisted knee replacement clinical trials 

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:

张旭 

研究负责人:

刘鹏飞 

Applicant:

Xu Zhang 

Study leader:

Pengfei Liu 

申请注册联系人电话:

Applicant telephone:

+86 17601233027 

研究负责人电话:

Study leader's telephone:

+86 13916280729 

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:

zhangxu@microport.com 

研究负责人电子邮件:

Study leader's E-mail:

liupengfei@microport.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:

上海市张东路1601号 

研究负责人通讯地址:

上海市张东路1601号 

Applicant address:

1601 Zhangdong Road, Shanghai, China 

Study leader's address:

1601 Zhangdong Road, 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:

苏州微创畅行机器人有限公司 

Applicant's institution:

MicroPort OrthoBot (SuZhou) Co., Ltd 

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:

SH9H-2019-C49-4 

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:

上海交通大学医学院附属第九人民医院转化医学伦理审查专委会  

Name of the ethic committee:

Transformation Medical Ethics Review Committee of the Ninth People's Hospital Affiliated to Shanghai Jiaotong University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-03 

伦理委员会联系人:

甄红 

Contact Name of the ethic committee:

Hong Zhen 

伦理委员会联系地址:

上海市制造局路639号 

Contact Address of the ethic committee:

639 Zhizaoju Road, Huangpu 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:

上海交通大学附属第九人民医院 

Primary sponsor:

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University  

研究实施负责(组长)单位地址:

上海市制造局路639号 

Primary sponsor's address:

639 Zhizaoju Road, Huangpu 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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第九人民医院

具体地址:

黄浦区制造局路639号

Institution
hospital:

Shanghai Ninth People's Hospital

Address:

639 Zhizaoju Road, Huangpu District

经费或物资来源:

申办方自筹 

Source(s) of funding:

The sponsor shall provide for itself 

研究疾病:

膝关节骨关节炎 

Target disease:

Knee osteoarthritis 

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:

评价骨科手术导航定位系统辅助膝关节置换术的有效性和安全性临床试验。 

Objectives of Study:

To evaluate the efficacy and safety of orthopedic surgical navigation and positioning system assisted knee replacement clinical trials. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1) 18周岁≤入组年龄≤80周岁; (2) 需进行单侧膝关节置换且无植入禁忌者; (3) 能够配合完成后续随访,有良好的依从性; (4) 自愿参加本试验并书面签署知情同意书。 

Inclusion criteria

(1) Aged 18 to 80 years; (2) Unilateral knee replacement is required and there is no implant contraindication; (3) Able to cooperate with follow-up visits and have good compliance; (4) Participate in the experiment voluntarily and sign the informed consent in person. 

排除标准:

(1) 同侧下肢主要关节(髋和膝关节)曾经进行置换术的受试者; (2) 膝內翻或膝外翻畸形大于 15 °; (3) 存在髋关节或踝关节的强直畸形; (4) 已知或者怀疑对聚乙烯、钛、钴、铬或者含铁元素材料过敏的; (5) 受试者由于疾病导致无法支撑和/或固定假体; (6) 近3个月内参与过其他研究性药物或器械临床试验者; (7) 其他研究者认为不适合本临床研究的情形。 

Exclusion criteria:

(1) Subjects who have had major joints (hip and knee) of the ipilateral lower extremity replaced; (2) Varus or valgus deformity of the knee greater than 15 degree; (3) Ankylosis of the hip or ankle joint is present; (4) Known or suspected allergy to polyethylene, titanium, cobalt, chromium or materials containing iron; (5) Subject is unable to support and/or fix the prosthesis due to disease; (6) Those who have participated in clinical trials of other research-based drugs or devices in the past 3 months; (7) Other researchers believe that the situation is not suitable for this clinical study. 

研究实施时间:

Study execute time:

From2020-08-24To 2021-10-25 

征募观察对象时间:

Recruiting time:

From2020-08-24To 2021-05-24 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

使用骨科手术导航定位系统辅助膝关节置换手术

干预措施代码:

Intervention:

Knee replacement surgery was assisted by orthopedic surgery navigation and positioning system

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(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属第九人民医院 

单位级别:

三甲 

Institution
hospital:

The Ninth People's Hospital affiliated to Shanghai Jiaotong University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

中国人民解放军陆军军医大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of PLA Army Military Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

贵州 

市(区县):

贵阳 

Country:

China 

Province:

Guizhou 

City:

Guiyang 

单位(医院):

贵州省人民医院 

单位级别:

三甲 

Institution
hospital:

Guizhou Provincial People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山东 

市(区县):

青岛 

Country:

China 

Province:

Shangdong 

City:

Qingdao 

单位(医院):

青岛大学附属医院 

单位级别:

三甲 

Institution
hospital:

The Affiliated Hospital of Qingdao University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

扬州 

Country:

China 

Province:

Jiangsu 

City:

Yangzhou 

单位(医院):

苏北人民医院 

单位级别:

三甲 

Institution
hospital:

North Jiangsu People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽省立医院 

单位级别:

三甲 

Institution
hospital:

Anhui Provincial Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床成功率

指标类型:

主要指标 

Outcome:

Clinical success rate

Type:

Primary indicator 

测量时间点:

第三次访视

测量方法:

临床成功的例数÷完成手术的例数×100%

Measure time point of outcome:

The third visit

Measure method:

The number of successful cases ÷ the number of completed cases ×100%

指标中文名:

股骨远端外侧角

指标类型:

次要指标 

Outcome:

LDFA

Type:

Secondary indicator 

测量时间点:

第三次访视

测量方法:

Measure time point of outcome:

The third visit

Measure method:

指标中文名:

胫骨近端内侧角

指标类型:

次要指标 

Outcome:

MPTA

Type:

Secondary indicator 

测量时间点:

第三次访视

测量方法:

Measure time point of outcome:

The third visit

Measure method:

指标中文名:

KSS评分

指标类型:

次要指标 

Outcome:

KSS

Type:

Secondary indicator 

测量时间点:

第三次访视

测量方法:

Measure time point of outcome:

The third visit

Measure method:

指标中文名:

WOMAC评分

指标类型:

次要指标 

Outcome:

WOMAC

Type:

Secondary indicator 

测量时间点:

第三次访视

测量方法:

Measure time point of outcome:

The third visit

Measure method:

指标中文名:

系统及附件性能评价

指标类型:

附加指标 

Outcome:

Performance evaluation of system and accessories

Type:

Additional 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:

NA

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 18 years
最大 Max age 80 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):

本实验为单臂研究,无需随机分组

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

This experiment is a single-arm study without random grouping.

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):

是否共享原始数据:

IPD sharing

否No

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):

试验结束后6个月,文章发表后

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

6 months after the end of the trial, it will be published in the form of articles

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:

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:

Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-22
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