注册号: Registration number: |
ChiCTR-INR-16009026 |
最近更新日期: Date of Last Refreshed on: |
2016-08-14 |
注册时间: Date of Registration: |
2016-08-14 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
止血带对全膝关节置换失血量、软组织损伤和骨水泥固定强度的影响:随机对照试验 |
Public title: |
Effects of tourniquet use on blood loss, soft-tissue damage and bone cement penetration in total knee arthroplasty: a randomized controlled trial |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
止血带对全膝关节置换失血量、软组织损伤和骨水泥固定强度的影响:随机对照试验 |
Scientific title: |
Effects of tourniquet use on blood loss, soft-tissue damage and bone cement penetration in total knee arthroplasty: a randomized controlled trial |
研究课题代号(代码): Study subject ID: |
卫计委卫生行业科研专项(201302007) |
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: |
曾羿 |
研究负责人: |
沈彬 |
Applicant: |
Zeng Yi |
Study leader: |
Shen Bin |
申请注册联系人电话: Applicant telephone: |
+86 13688069779 |
研究负责人电话: Study leader's telephone: |
+86 18980601390 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
zengyigd@126.com |
研究负责人电子邮件: Study leader's E-mail: |
shenbin_1971@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): |
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申请注册联系人通讯地址: |
四川省成都市武侯区国学巷37号华西医院骨科 |
研究负责人通讯地址: |
四川省成都市武侯区国学巷37号华西医院骨科 |
Applicant address: |
37 Guoxuexiang, Chengdu, China |
Study leader's address: |
37 Guoxuexiang, Chengdu, 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: |
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申请人所在单位: |
四川大学华西医院 |
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Applicant's institution: |
West China Hospital, Sichuan University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2012-268 |
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: |
四川大学华西医院临床试验与生物医学伦理专委会 |
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Name of the ethic committee: |
Clinical trials and biomedical ethics committee, West China Hospital, Sichuan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
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伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
四川大学华西医院骨科 |
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Primary sponsor: |
Department of Orthopedics, West China Hospital, Sichuan University |
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研究实施负责(组长)单位地址: |
四川省成都市武侯区国学巷37号华西医院骨科 |
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Primary sponsor's address: |
37 Guoxuexiang, Chengdu, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
卫计委卫生行业科研专项(201302007) |
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Source(s) of funding: |
National Health and Family Planning Comission of the PRC, Health Industry Scientific Research (201302007) |
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研究疾病: |
骨关节炎 |
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Target disease: |
osteoarthritis |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
治疗新技术临床试验 | ||||||||||||||||||||||
Study phase: |
New Treatment Measure Clinical Study |
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研究目的: |
比较骨关节患者接受全膝关节置换手术,术中是否放置止血带对围术期失血量、软组织损伤和骨水泥固定强度的影响 |
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Objectives of Study: |
for osteoarthritis patients need total knee arthroplasty, this study will be performed to evaluate the effects of tourniquet use on blood loss, soft tissue damage and bone cement penetration. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
在我院诊断为膝关节骨关节炎并接受膝关节置换的患者 |
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Inclusion criteria |
patients undergoing total knee arthroplasty for the treatment of osteoarthritis will be recruited for our trial |
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排除标准: |
接受膝关节置换的非骨关节炎患者;术前合并高血压、凝血功能障碍和周围血管疾病的患者 |
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Exclusion criteria: |
patients undergoing total knee arthroplasty for the treatment of non-osteoarthritis disease; patients with hypertension, coagulapathy and peripheral vascular disease. |
研究实施时间: Study execute time: |
从From2016-09-01至To |
征募观察对象时间: Recruiting time: |
从From2016-09-01至To 2016-12-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
计算机随机 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
computer random method |
盲法: |
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Blinding: |
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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): |
共享时间:2017年6月;共享方式:网络共享(网址 http://user.qzone.qq.com/51371770/2) |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
time of data share:2017-6;way of data share: internet share (http://user.qzone.qq.com/51371770/2) |
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: |
原始数据通过卫生行业科研专项数据库收集、保存和传输 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
all original data will be collected, preserved and transmissed using health industry scientific research program. |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |