Today is 2021-07-24

Efficacy and safety of knee joint surgery navigation system in total knee arthroplasty
download

注册号:

Registration number:

ChiCTR2100047691 

最近更新日期:

Date of Last Refreshed on:

2021-06-22 

注册时间:

Date of Registration:

2021-06-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

膝关节手术导航系统辅助用于全膝关节置换手术的有效性和安全性临床试验 

Public title:

Efficacy and safety of knee joint surgery navigation system in total knee arthroplasty 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膝关节手术导航系统辅助用于全膝关节置换手术的有效性和安全性临床试验 

Scientific title:

Efficacy and safety of knee joint surgery navigation system in total knee arthroplasty 

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:

丁乐乐 

研究负责人:

林进 

Applicant:

LELE DING 

Study leader:

JIN LIN 

申请注册联系人电话:

Applicant telephone:

+86 15810728567 

研究负责人电话:

Study leader's telephone:

+86 13601157900 

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:

dll@hhrbrobot.com 

研究负责人电子邮件:

Study leader's E-mail:

linjinpumc@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:

北京市经济技术开发区锋创科技园5号楼15层 

研究负责人通讯地址:

北京市东城区帅府园一号 

Applicant address:

15th floor , Building 5, Courtyard 18, Kechuang 13th Street, Beijing Economic- Technological Development Area, Beijing 

Study leader's address:

1 Shuaifuyuan, Wangfujing, Dongcheng District, Beijing, 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:

北京和华瑞博医疗科技有限公司 

Applicant's institution:

Beijing HURWA-ROBOT Medical Technology 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:

KS2019532 

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:

中国医学科学院北京协和医院药物临床试验伦理委员会 

Name of the ethic committee:

Ethics Review Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-28 

伦理委员会联系人:

王佳乐 

Contact Name of the ethic committee:

Wang Jiale 

伦理委员会联系地址:

北京西城区大木仓胡同41号 

Contact Address of the ethic committee:

41 Damucang Hutong, Xicheng District, Beijing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 010-69158355 

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:

中国医学科学院北京协和医院 

Primary sponsor:

Peking Union Medical College Hospital 

研究实施负责(组长)单位地址:

北京市东城区帅府园一号 

Primary sponsor's address:

No.1 Shuaifuyuan,Wangfujing, Dongcheng District, Beijing, 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):

北京市

市(区县):

北京市

Country:

China

Province:

Peking

City:

Peking

单位(医院):

北京和华瑞博医疗科技有限公司

具体地址:

北京市经济技术开发区锋创科技园5号楼15层

Institution
hospital:

Beijing HURWA-ROBOT Medical Technology Co.Ltd

Address:

15th floor, Building 5, Courtyard 18, Kechuang 13th Street, Beijing Economic- Technological Development Area, Beijing

经费或物资来源:

申办方自筹资金 

Source(s) of funding:

Self financing by the sponsor 

研究疾病:

膝骨关节炎 

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:

利用膝关节手术导航系统辅助进行全膝关节置换手术,与传统人工全膝关节置换术治疗的数据相比较,评价膝关节手术导航系统辅助用于全膝关节置换手术的有效性及安全性。 

Objectives of Study:

Objective to evaluate the effectiveness and safety of knee joint surgery navigation system in total knee arthroplasty. 

药物成份或治疗方案详述:

本临床试验为前瞻性研究,选择因骨关节炎、类风湿关节炎、创伤性关节炎等终末期膝关节病变拟行初次单侧全膝关节置换术治疗的患者为研究对象,预期在至少3家研究机构共纳入合格受试者至少152例。 将受试者随机平均分为试验组和对照组,试验组受试者使用试验用医疗器械(膝关节手术导航系统)辅助术者进行全膝关节置换术,对照组受试者进行传统的人工全膝关节置换术,两组受试者的手术均由同一经验丰富的研究者及其团队完成;所有受试者均采用同一类型的假体置入物。 除了术前的筛选访视外,入组后的受试者将进行术后当天访视、出院访视,并在术后12周±10天完成1次随访。在上述访视时间收集受试者治疗期间和术后的临床数据和指标,包括主要评价指标:术后下肢力线纠正率(术后12周±10天),次要评价指标:膝关节活动度(术后12周±10天)、HSS评分(术后12周±10天)、KSS评分(术后12周±10天)、WOMAC评分(术后12周±10天)、SF-36健康量表(术后12周±10天)、手术时间(术中);安全性评价指标:再手术发生率(术后12周±10天)、术中并发症(术中)、术后并发症(术后12周±10天)、AE/SAE(术后12周±10天)、器械缺陷(术中)发生情况。主要评价指标将采取盲态评价。 将上述收集的数据进行组间分析对比,以评价膝关节手术导航系统辅助用于全膝关节置换手术时的有效性及安全性。为试验用医疗器械在本次注册申报中提供临床试验证据。 

Description for medicine or protocol of treatment in detail:

This clinical trial is a prospective study. Patients with end-stage knee diseases such as osteoarthritis, rheumatoid arthritis and traumatic arthritis who are to undergo primary unilateral total knee arthroplasty are selected as the research objects. At least 152 eligible subjects are expected to be included in at least three research institutions. The subjects were randomly divided into the experimental group and the control group. The experimental group used the experimental medical device (knee surgery navigation system) to assist the operator in total knee arthroplasty, while the control group used the traditional total knee arthroplasty; The same type of prosthesis was used in all subjects. In addition to the pre-operative screening visit, the enrolled subjects will be visited on the same day after surgery, discharged from hospital, and 12 weeks after surgery ± One follow-up was completed in 10 days. The clinical data and indicators during and after the treatment were collected at the above visit time, including the main evaluation indicators: postoperative lower limb alignment correction rate (12 weeks after operation) ± Secondary outcome measures: range of motion of knee joint (12 weeks after operation) ± 10 days), HSS score (12 weeks after operation) ± 10 days), KSS score (12 weeks after operation) ± WOMAC score (12 weeks after operation) ± 10 days), SF-36 Health Scale (12 weeks after operation) ± 10 days), operation time (intraoperative); Safety evaluation index: reoperation rate (12 weeks after operation) ± 10 days), intraoperative complications (intraoperative), postoperative complications (12 weeks after operation) ± 10 days), AE / SAE (12 weeks after operation) ± 10 days), the occurrence of device defects (intraoperative). The main evaluation indexes will adopt blind evaluation. The collected data were analyzed and compared between groups to evaluate the effectiveness and safety of knee surgery navigation system in total knee arthroplasty. To provide clinical trial evidence for the medical devices for trial in this registration application. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 年龄不小于18周岁,性别不限; (2) 需进行初次、单侧全膝关节置换术者; (3) 受试者/监护人能够理解试验目的,显示对试验方案足够的依从性,并签署知情同意书(Informed Consent Form,ICF); 

Inclusion criteria

1. Aged >=18 years old; 2. Patients who need primary or unilateral total knee arthroplasty; 3. The subject / guardian can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form (ICF). 

排除标准:

(1) 有TKA传统手术的禁忌证者: a) 下肢瘫痪或存在神经性关节病变(Charcot关节)者; b) 下肢有神经肌肉功能障碍(例如:小儿麻痹后遗症、肌无力等)会导致术后膝关节不稳定、步态异常或难以康复者; c) 全身严重疾病(严重糖尿病、严重心脏病、严重肝肾功能不全等、活动性结核感染、出血性疾病); d) 膝关节周围或全身存在活动性感染者; (2) 患肢深静脉血栓者; (3) 患肢有膝关节手术、外伤或骨折史影响本项目评估及手术安全; (4) 受试者呈免疫抑制状态,患有自身免疫疾病或免疫抑制障碍。例如患者正在使用免疫抑制治疗(大剂量皮质醇,细胞毒性药物,抗淋巴细胞血清,或大剂量辐射)或患有获得性免疫缺陷综合征; (5) 妊娠或哺乳期女性; (6) 受试者最近3个月内曾参加过其他药物、生物制剂或器械临床研究; (7) 已知过度饮酒或药物滥用的患者; (8) 研究者认为不适宜参加本临床试验者。 

Exclusion criteria:

1. The contraindications of TKA were as follows 1) Patients with lower limb paralysis or neuropathic joint disease (Charcot joint); 2) Patients with neuromuscular dysfunction of lower limbs (e.g. sequelae of poliomyelitis, myasthenia, etc.) may lead to postoperative knee instability, abnormal gait or difficulty in recovery; 3) Severe systemic disease (severe diabetes, serious heart disease, severe liver and kidney dysfunction, active tuberculosis infection, hemorrhagic disease). 4) Patients with active infection around knee joint or all over the body; 2. Deep venous thrombosis of the affected limb; 3. The affected limb has a history of knee joint surgery, trauma or fracture, which affects the evaluation and operation safety of the project; 4. The subjects were immunosuppressed and suffered from autoimmune diseases or immunosuppressive disorders. For example, the patient is receiving immunosuppressive therapy (high-dose cortisol, cytotoxic drugs, anti lymphocyte serum, or high-dose radiation) or has acquired immunodeficiency syndrome; 5. Pregnant or lactating women; 6. The subjects have participated in clinical studies of other drugs, biological agents or devices in the last three months; 7. Patients with known excessive drinking or drug abuse; 8. The researcher thinks that it is not suitable to participate in this clinical trial. 

研究实施时间:

Study execute time:

From2020-01-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2020-08-31 

干预措施:

Interventions:

组别:

试验组

样本量:

76

Group:

Experimental group

Sample size:

干预措施:

膝关节手术导航系统辅助用于全膝关节置换手术

干预措施代码:

Intervention:

Application of navigation system in total knee arthroplasty

Intervention code:

组别:

对照组

样本量:

76

Group:

control group

Sample size:

干预措施:

传统人工全膝关节置换术

干预措施代码:

Intervention:

Traditional total knee arthroplasty

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

北京市 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国医学科学院北京协和医院 

单位级别:

三甲医院 

Institution
hospital:

Peking Union Medical College Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京市 

市(区县):

北京市 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京朝阳医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Chaoyang Hospital of Capital Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

天津市 

市(区县):

天津市 

Country:

China 

Province:

Tianjin 

City:

Tianjin 

单位(医院):

天津市天津医院 

单位级别:

三甲医院 

Institution
hospital:

TIANJIN hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后下肢力线纠正率

指标类型:

主要指标 

Outcome:

Correction rate of lower limb alignment after operation

Type:

Primary indicator 

测量时间点:

术后12周±10天

测量方法:

影像学测量

Measure time point of outcome:

12 weeks +/-10 days, after operation

Measure method:

Imaging measurement

指标中文名:

HSS评分

指标类型:

次要指标 

Outcome:

HSS

Type:

Secondary indicator 

测量时间点:

术后12周±10天

测量方法:

量表

Measure time point of outcome:

12 weeks after operation +/- 10 days

Measure method:

scale

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:

术后12周±10天

测量方法:

量表

Measure time point of outcome:

12 weeks after operation+/- 10 days

Measure method:

scale

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:

术后12周±10天

测量方法:

量表

Measure time point of outcome:

12 weeks after operation +/- 10 days

Measure method:

scale

指标中文名:

SF-36健康量表

指标类型:

次要指标 

Outcome:

SF-36

Type:

Secondary indicator 

测量时间点:

术后12周±10天

测量方法:

量表

Measure time point of outcome:

12 weeks after operation +/- 10 days

Measure method:

scale

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 18 years
最大 Max age 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):

本试验采用分层区组的随机方法,按临床试验机构分层。用SAS 9.4统计软件编程,给定种子数和区组长度,按1:1比例将受试对象分为试验组和对照组,产生至少152例受试者的随机分组安排,并制作相应的顺序编号、不透光、密封的信封。随机信封由不参与受试者筛选及治疗,并经研究者授权的相关人员保管并执行分配。 随机编号为“中心编号”和“流水号”组成的4位数的顺序编号(一般为中心编号占的位数加样本量占的位数),第1位数为临床试验机构编号(详见多中心临床试验所有临床试验机构和研究者列表),后3位数为随机化分配的“流水号”,流水号不足3位时往前加0补足3位。如随机编号“1001”为临床试验机构1的第一个随机编号,对应于该中心第一个随机化分配的受试者。

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

The randomized method of stratified block was used in this study, which was stratified by clinical trial institution. SAS 9.4 statistical software was used to program. Given the number of seeds and block length, the subjects were divided into the experimental group and the control group according to the

盲法:

本研究为单盲试验,将对受试者设盲。只有当受试者确需获知治疗措施,以便行进一步诊疗时,由临床试验机构的主要研究者或其授权的人员告知受试者其采用的治疗措施。 对本试验的主要评价指标,选择独立于知晓分组研究者的盲态研究者进行评估,对于次要指标及安全性指标不采取研究者盲态评估。

Blinding:

This study is a single blind trial, and the subjects will be blinded. Only when the subject really needs to be informed of the treatment for further diagnosis and treatment, the principal investigator of the clinical trial institution or his authorized personnel will inform the subject of the treatment. For the main evaluation indexes of this trial, blind researchers independent of the knowledge grouping researchers were selected for evaluation, and the secondary indexes and safety indexes were not evaluated by blind researchers.

是否共享原始数据:

IPD sharing

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):

公开发表的学术论文中公布

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

Published in published academic papers

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:

ECRF表和EDC

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

ECRF、EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-06-22
return list