Today is 2020-07-05

Robot-assisted Percutaneous Vertebroplasty under local anesthesia for the Treatment of Osteoporotic Thoracolumbar Fractures
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注册号:

Registration number:

ChiCTR2000031185 

最近更新日期:

Date of Last Refreshed on:

2020-03-23 

注册时间:

Date of Registration:

2020-03-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

局麻下机器人辅助经皮椎体成形术治疗骨质疏松性脊柱压缩骨折 

Public title:

Robot-assisted Percutaneous Vertebroplasty under local anesthesia for the Treatment of Osteoporotic Thoracolumbar Fractures 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

局麻下机器人辅助经皮椎体成形术治疗骨质疏松性脊柱压缩骨折 

Scientific title:

Robot-assisted Percutaneous Vertebroplasty under local anesthesia for the Treatment of Osteoporotic Thoracolumbar Fractures 

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:

石斌 

研究负责人:

张立海 

Applicant:

Shi Bin 

Study leader:

Zhang LiHai 

申请注册联系人电话:

Applicant telephone:

+86 13439599763 

研究负责人电话:

Study leader's telephone:

+86 13810745151 

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:

s05104@163.com 

研究负责人电子邮件:

Study leader's E-mail:

Zhanglihai74@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:

北京市复兴路28号 

研究负责人通讯地址:

北京市复兴路28号 

Applicant address:

28 Fuxing Road, Haidian District, Beijing, China 

Study leader's address:

28 Fuxing Road, Haidian District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100853 

研究负责人邮政编码:

Study leader's postcode:

100853 

申请人所在单位:

中国人民解放军总医院 

Applicant's institution:

Chinese PLA General Hospital 

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:

中国人民解放军总医院 

Primary sponsor:

Chinese PLA General Hospital 

研究实施负责(组长)单位地址:

北京市复兴路28号中国人民解放军总医院 

Primary sponsor's address:

28 Fuxing Road, Haidian 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军总医院

具体地址:

北京市复兴路28号

Institution
hospital:

Chinese PLA General Hospital

Address:

28 Fuxing Road, Haidian District

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

航天总医院

具体地址:

北京市丰台区万源北路7号

Institution
hospital:

Beijing aerospace general hospital

Address:

7 Wanyuan Road North

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-raised funds 

研究疾病:

骨质疏松性椎体压缩骨折 

Target disease:

osteoporotic vertebral compression fractures 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

介绍一种新型辅助经椎弓根穿刺的脊柱机器人导航系统(佐航 ZOEZEN),观察该技术在局麻下实现的可行性,并通过临床实验,比较其与传统透视引导下徒手穿刺技术的效果差异。 

Objectives of Study:

The idea of this study was to introduce a new system (ZOEZEN) of robot-assisted percutaneous pedicle puncture, observe the feasibility of this technique under local anesthesia and compare its clinical effect with that of traditional fluoroscopy-guided freehand puncture. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

(1)男>60岁,女>55岁;椎体骨密度( bone mineral density,BMD) 测定明确诊断为骨质疏松症; (2)MRI检查提示新鲜骨折; (3)CT检查示椎体后壁完整,无椎管内占位和脊髓压迫; (4)无下肢神经症状; (5)患者知情同意。 

Inclusion criteria

1. male > 60 years old, female > 55 years old; diagnosis of osteoporosis; 2. MRI prompted fresh fractures; 3. CT shows the complete of vertebral body wall , no bone fragments in vertebral canal and spinal cord compression; 4. no lower limb nerve symptoms; 5. patients' informed consent. 

排除标准:

(1)病理性骨折; (2)椎体爆裂性骨折或椎体后壁破裂的压缩骨折; (3)陈旧性胸腰椎骨折; (4)身体条件差,无法耐受手术或不能配合手术者; (5)临床机构认为不适宜受试的患者。 

Exclusion criteria:

(1) pathological fracture; (2) vertebral burst fracture or vertebral body wall rupture after compression fractures; (3) old thoracolumbar fractures; (4) poor condition, can't tolerate surgery; (5) the clinical institutions think not suitable. 

研究实施时间:

Study execute time:

From2017-10-17To 2019-12-03 

干预措施:

Interventions:

组别:

机器人组

样本量:

14

Group:

Robot group

Sample size:

干预措施:

机器人引导下PVP

干预措施代码:

Intervention:

robot-assisted PVP

Intervention code:

组别:

徒手组

样本量:

16

Group:

Free-hand group

Sample size:

干预措施:

徒手透视下PVP

干预措施代码:

Intervention:

Free-hand PVP

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲医院 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

穿刺时间

指标类型:

主要指标 

Outcome:

puncture 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:

穿刺透视时间

指标类型:

主要指标 

Outcome:

puncture exposure 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:

疼痛评分

指标类型:

主要指标 

Outcome:

VAS score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Oswestry功能障碍指数

指标类型:

主要指标 

Outcome:

ODI score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

次要指标 

Outcome:

age

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

次要指标 

Outcome:

sex

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高体重指数

指标类型:

次要指标 

Outcome:

BMI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

次要指标 

Outcome:

BMD

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出血量

指标类型:

次要指标 

Outcome:

Blood

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:

X-ray 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:

标本中文名:

组织:

Sample Name:

No

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 57 years
最大 Max age 86 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):

No

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

网络

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

Web

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-23
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