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The Clinical Contrast study for Percutaneous Endoscopic Lumbar Discectomy Assisted by O-Arm-Based Navigation and traditional X-way
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注册号:

Registration number:

ChiCTR1800019586 

最近更新日期:

Date of Last Refreshed on:

2018-11-19 

注册时间:

Date of Registration:

2018-11-19 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

O臂导航下椎间孔镜下髓核摘除术与传统X光引导下椎间孔镜下髓核摘除术的临床对比研究 

Public title:

The Clinical Contrast study for Percutaneous Endoscopic Lumbar Discectomy Assisted by O-Arm-Based Navigation and traditional X-way 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

O臂导航下椎间孔镜下髓核摘除术与传统X光引导下椎间孔镜下髓核摘除术的临床对比研究 

Scientific title:

The Clinical Contrast study for Percutaneous Endoscopic Lumbar Discectomy Assisted by O-Arm-Based Navigation and traditional X-way 

研究课题代号(代码):

Study subject ID:

No. 2015YLC22 

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:

敖圣翔 

研究负责人:

敖圣翔 

Applicant:

Shengxiang Ao 

Study leader:

Shengxiang Ao 

申请注册联系人电话:

Applicant telephone:

+86 18523826996 

研究负责人电话:

Study leader's telephone:

+86 18523826996 

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:

sanyida2008@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

sanyida2008@sina.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:

重庆市沙坪坝区新桥正街183号新桥医院 

研究负责人通讯地址:

重庆市沙坪坝区新桥正街183号新桥医院 

Applicant address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

Study leader's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400037 

研究负责人邮政编码:

Study leader's postcode:

400037 

申请人所在单位:

陆军军医大学第二附属新桥医院 

Applicant's institution:

The Second Affiliated Xinqiao Hospital of Army Medical University 

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:

201708010 

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:

中国人民解放军陆军军医大学第二附属医院医学伦理委员会  

Name of the ethic committee:

The Medical Ethics Committee of the Second Affiliated Hospital of Army Medical University, PLA  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-08-02 

伦理委员会联系人:

邓璠 

Contact Name of the ethic committee:

Fan Deng 

伦理委员会联系地址:

重庆市沙坪坝区新桥正街83号新桥医院 

Contact Address of the ethic committee:

183 Xinqiao Main Street, Shapingba District, Chongqing, 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:

陆军军医大学第二附属新桥医院 

Primary sponsor:

The Second Affiliated Xinqiao Hospital of Army Medical University 

研究实施负责(组长)单位地址:

重庆市沙坪坝区新桥正街83号 

Primary sponsor's address:

183 Xinqiao Main Street, Shapingba District, Chongqing, 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):

重庆

市(区县):

沙坪坝区

Country:

China

Province:

Chongqing

City:

Shapingba District

单位(医院):

新桥医院

具体地址:

重庆市沙坪坝区新桥正街83号新桥医院

Institution
hospital:

Xinqiao Hospital

Address:

183 Xinqiao Main Street, Shapingba District, Chongqing, China

经费或物资来源:

陆军军医大学第二附属医院临床研究项目 (Grant No. 2015YLC22) 

Source(s) of funding:

The clinical research project of the Second Affiliated Hospital of Army Medical University (Grant No. 2015YLC22) 

研究疾病:

腰椎间盘突出症 

Target disease:

Lumbar disc herniation 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评价O臂导航下椎间孔镜下髓核摘除术治疗腰椎间盘突出症的安全性以及效率,并与传统X光引导下椎间孔镜下髓核摘除术进行临床结果对比。 

Objectives of Study:

The aim of this study is to assess the safety and efficacy of percutaneous endoscopic lumbar discectomy (PELD) assisted by O-arm-based navigation for treating lumbar disc herniation (LDH), and compare with traditional PELD under X-way. 

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)年龄≥18岁并≤ 70岁;2)典型的单节段神经根病变的临床症状和体征;3)与临床相符的单节段腰椎间盘突出的影像学表现(限定于L3-4, L4-5或L5-S1),例如CT和核磁共振结果;4)术前保守治疗3个月无效。 

Inclusion criteria

1) aged 18 to 70 years; 2) typical clinical symptoms and signs of mono-radiculopathy LDH; 3) concordant imaging evidence of single LDH (limited to L3-4, L4-5 or L5-S1), such as computed tomography (CT) and magnetic resonance imaging (MRI); 4) conservative therapy for at least 3 months before surgery. 

排除标准:

1)患有严重潜在疾病或精神疾病;2)合并有重度椎管狭窄、马尾综合征、脊柱不稳定、感染活动期、髓核严重钙化;3)术前接受过脊柱手术、臭氧介入治疗或者射频消融治疗;4)不愿或者不能接受治疗以及后期临床随访。 

Exclusion criteria:

1) serious underlying disease or mental illnesses; 2) combined with severe central stenosis, cauda equina syndrome, spinal instability, active infection, serious calcified fragments; 3) previous lumbar treatment with spinal surgery, ozone intervention or radiofrequency ablation; 4) unwilling or unable to participate in treatment and complete follow-up. 

研究实施时间:

Study execute time:

From2017-09-01To 2018-01-31 

干预措施:

Interventions:

组别:

导航组

样本量:

58

Group:

Group 1

Sample size:

干预措施:

O臂导航下

干预措施代码:

Intervention:

O-arm-based navigation assisted

Intervention code:

组别:

X光组

样本量:

60

Group:

Group 2

Sample size:

干预措施:

传统X光引导下

干预措施代码:

Intervention:

Traditional X-way assisted

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

沙坪坝 

Country:

China 

Province:

Chongqing 

City:

Shapingba District 

单位(医院):

新桥医院 

单位级别:

三级甲等 

Institution
hospital:

Xinqiao Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

Operation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

通道放置时间

指标类型:

次要指标 

Outcome:

Cannula placement time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰背部VAS评分

指标类型:

次要指标 

Outcome:

VAS of low back

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腿部VAS评分

指标类型:

次要指标 

Outcome:

VAS of leg

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ODI评分

指标类型:

次要指标 

Outcome:

ODI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Macnab 评分

指标类型:

次要指标 

Outcome:

Macnab criteria

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

放射暴露时间

指标类型:

次要指标 

Outcome:

Radiation exposure time

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

未随机

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

Not Randomized

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

通过ResMan提供原始数据查询

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

IPD will be shareded via ResMan

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:

研究实施单位统一管理

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

The institution who conducting the research will be responsible for the management of the data

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-11-19
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