注册号: Registration number: |
ChiCTR1900025668 |
最近更新日期: Date of Last Refreshed on: |
2019-09-04 |
注册时间: Date of Registration: |
2019-09-04 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件。 自制抗生素骨水泥间隔物在THA后感染翻修术中的应用队列研究 |
Public title: |
Cohort study for self-made antibiotic cement spacer in the revision of THA infection |
注册题目简写: |
|
English Acronym: |
|
研究课题的正式科学名称: |
自制抗生素骨水泥间隔物在THA后感染翻修术中的应用队列研究 |
Scientific title: |
Cohort study for self-made antibiotic cement spacer in the revision of THA infection |
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: |
孙健宁 |
研究负责人: |
冯硕 |
Applicant: |
Jianning Sun |
Study leader: |
Shuo Feng |
申请注册联系人电话: Applicant telephone: |
+86 17605276549 |
研究负责人电话: Study leader's telephone: |
+86 18552880088 |
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: |
1342071057@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
781733181@qq.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: |
江苏省徐州市淮海西路99号 |
研究负责人通讯地址: |
江苏省徐州市淮海西路99号 |
Applicant address: |
99 Huaihai Road West, Xuzhou, Jiangsu, China |
Study leader's address: |
99 Huaihai Road West, Xuzhou, 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: |
徐州医科大学附属医院 |
||
Applicant's institution: |
Affiliated Hospital of Xuzhou Medical University |
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: |
徐州医科大学附属医院 |
||||||||||||||||||||||
Primary sponsor: |
Affiliated Hospital of Xuzhou Medical University |
||||||||||||||||||||||
研究实施负责(组长)单位地址: |
江苏省徐州市淮海西路99号 |
||||||||||||||||||||||
Primary sponsor's address: |
99 Huaihai Road West, Xuzhou, Jiangsu, China |
||||||||||||||||||||||
试验主办单位(项目批准或申办者): Secondary sponsor: |
|
||||||||||||||||||||||
经费或物资来源: |
无 |
||||||||||||||||||||||
Source(s) of funding: |
no |
||||||||||||||||||||||
研究疾病: |
髋关节置换术后感染 |
||||||||||||||||||||||
Target disease: |
Infection after hip replacement |
||||||||||||||||||||||
研究疾病代码: |
|
||||||||||||||||||||||
Target disease code: |
|
||||||||||||||||||||||
研究类型: |
预后研究 |
||||||||||||||||||||||
Study type: |
Prognosis study |
||||||||||||||||||||||
研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
||||||||||||||||||||||
研究目的: |
研究自制抗生素骨水泥间隔物在THA后感染翻修术中的应用效果 |
||||||||||||||||||||||
Objectives of Study: |
Study on the application effect of self-made antibiotic bone cement spacer in the repair of THA infection |
||||||||||||||||||||||
药物成份或治疗方案详述: |
|
||||||||||||||||||||||
Description for medicine or protocol of treatment in detail: |
|
||||||||||||||||||||||
研究设计: |
队列研究 |
||||||||||||||||||||||
Study design: |
Cohort study |
||||||||||||||||||||||
纳入标准: |
1、完整临床病史和体检、血清学检查、影像学检查结果。 2、明确THA感染诊断。 3、使用自制骨水泥间隔物行感染旷置术。 4、获得完整随访 |
||||||||||||||||||||||
Inclusion criteria |
1. Complete clinical history and physical examination, serological examination, and imaging examination results; 2. Identify the diagnosis of THA infection; 3. using self-made bone cement spacers to infect the sputum; 4. get complete follow-up. |
||||||||||||||||||||||
排除标准: |
1、浅表和深部THA感染的单纯清创。 2、一期翻修及化脓性关节炎间隔物植入术。 3、采用其他方法行感染旷置术。 4、保守治疗 |
||||||||||||||||||||||
Exclusion criteria: |
1. Simple debridement of superficial and deep THA infection; 2. Phase I revision and septic arthritis spacer implantation; 3. using other methods of infection surgery; 4. conservative treatment. |
||||||||||||||||||||||
研究实施时间: Study execute time: |
从From2019-09-04至To 2023-09-04 |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|
采集人体标本:
Collecting sample(s)
|
|
征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
|
||||||
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): |
无 |
||||||||
Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
盲法: |
N/A |
Blinding: |
N/A |
试验完成后的统计结果(上传文件): |
|
Calculated Results after
|
|
原始数据公开时间: The time of sharing IPD: |
即时公开/Real time access |
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): |
发表论文 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
publish 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: |
电子医生站 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Electronic doctor station |
数据管理委员会: Data Managemen Committee: |
有/Yes |