中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR-IOR-15006942
最近更新日期： Date of Last Refreshed on：	2015-08-20 22:31:28
注册时间： Date of Registration：	2015-08-20 21:49:42
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用
Public title：	RCT mesenchymal stem cells versus hyaluronic acid in OA knee
注册题目简写：
English Acronym：
研究课题的正式科学名称：	比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用
Scientific title：	RCT mesenchymal stem cells versus hyaluronic acid in OA knee
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：	CUHK_CCT00469

申请注册联系人：	Jenny ZHANG Jing	研究负责人：	Prof. Kevin HO Ki Wai
Applicant：	Jenny ZHANG Jing	Study leader：	Prof. Kevin HO Ki Wai
申请注册联系人电话： Applicant telephone：	+852 26326553	研究负责人电话： Study leader's telephone：	+852 26322715
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：	jennyzhang1009@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	kevinho@cuhk.edu.hk
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00469	研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：	http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00469
申请注册联系人通讯地址：	Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, Hong Kong	研究负责人通讯地址：	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Applicant address：	Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Shatin, Hong Kong	Study leader's address：	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
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：	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Applicant's institution：	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
研究负责人所在单位：
Affiliation of the Leader：

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：	NA	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：	The Chinese University of Hong Kong
Name of the ethic committee：	The Chinese University of Hong Kong
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
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：

Prof. Kevin HO Ki Wai

Primary sponsor：

Prof. Kevin HO Ki Wai

研究实施负责（组长）单位地址：

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Primary sponsor's address：

Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中國	省(直辖市)：	香港特別行政區	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	Prof. G. Li	具体地址：	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
Institution hospital：	Prof. G. Li	Address：	Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

经费或物资来源：

The Chinese University of Hong Kong

Source(s) of funding：

The Chinese University of Hong Kong

研究疾病：

Degenerative osteoarthritis of the knee

Target disease：

Degenerative osteoarthritis of the knee

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

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

比較膝關節内注射間充質幹細胞及透明質酸用於治療膝關節炎的效用

Objectives of Study：

RCT mesenchymal stem cells versus hyaluronic acid in OA knee

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

The presence of one or more of the following criteria will exclude the patient from the study:
1. Patients with previous cases of alcoholism or drug abuse;
2. Pregnancy and breast-feeding;
3. Presence of serious pathologies;
4. Hypersensitivity towards hyaluronic acid;
5. Intra-articular infiltrations of hyaluronic acid or steroids that are in the process of being administered or that have been interrupted since less than 3 months;
6. Steroid-based systemic therapy in progress or interrupted since less than 1 month and/or anti-clotting drugs;
7. History of fractures and/or severe traumas of the knee bone;
8. Significant hematologic diseases;
9. Non-consenting patients who have not provided the written Informed Consent;
10. Mechanical instability, ligamentous laxity/deficiency and gross deformity;
11. Isolated meniscal tear without evident of osteoarthritis.

Exclusion criteria：

The presence of one or more of the following criteria will exclude the patient from the study:
1. Patients with previous cases of alcoholism or drug abuse;
2. Pregnancy and breast-feeding;
3. Presence of serious pathologies;
4. Hypersensitivity towards hyaluronic acid;
5. Intra-articular infiltrations of hyaluronic acid or steroids that are in the process of being administered or that have been interrupted since less than 3 months;
6. Steroid-based systemic therapy in progress or interrupted since less than 1 month and/or anti-clotting drugs;
7. History of fractures and/or severe traumas of the knee bone;
8. Significant hematologic diseases;
9. Non-consenting patients who have not provided the written Informed Consent;
10. Mechanical instability, ligamentous laxity/deficiency and gross deformity;
11. Isolated meniscal tear without evident of osteoarthritis.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2015-12-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：	Two groups	样本量：	30
Group：	Two groups	Sample size：	30
干预措施：	To compare the effect of mesenchymal stem cells and hyaluronic acid on treating osteoarthritis of the knee, after intra-articular injection of both	干预措施代码：
Intervention：	To compare the effect of mesenchymal stem cells and hyaluronic acid on treating osteoarthritis of the knee, after intra-articular injection of both	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中國	省(直辖市)：	香港特別行政區	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	The Chinese University of Hong Kong	单位级别：	The Chinese University of Hong Kong
Institution hospital：	The Chinese University of Hong Kong	Level of the institution：	The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：	Functional osteoarthritis scores including WOMAC,KSS and KSFS, SF-36 and VAS pain scores will be assessed at 2 weeks, 3 months, 6 months, 9 months and 12 months post-operation	指标类型：	主要指标
Outcome：	Functional osteoarthritis scores including WOMAC,KSS and KSFS, SF-36 and VAS pain scores will be assessed at 2 weeks, 3 months, 6 months, 9 months and 12 months post-operation	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Radiologic knee osteoarthritis will be assessed by MRI-and X-ray before operation, 3 months and 12 months post-operation	指标类型：	主要指标
Outcome：	Radiologic knee osteoarthritis will be assessed by MRI-and X-ray before operation, 3 months and 12 months post-operation	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Adverse event will be monitored during the study	指标类型：	主要指标
Outcome：	Adverse event will be monitored during the study	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Analgesic/NSAIDs consumption	指标类型：	次要指标
Outcome：	Analgesic/NSAIDs consumption	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Crackling sounds with movement (subjective evaluation)	指标类型：	次要指标
Outcome：	Crackling sounds with movement (subjective evaluation)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Per-articular swelling (thigh and knee circumference evaluation)	指标类型：	次要指标
Outcome：	Per-articular swelling (thigh and knee circumference evaluation)	Type：	Secondary 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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	岁 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）：

Randomized

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

Randomized

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing
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）：
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：
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：
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：
数据与安全监察委员会： Data and Safety Monitoring Committee：
注册人： Name of Registration：	2015-08-20 22:31:28