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精准椎间孔成型术治疗腰椎管狭窄
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注册号:

Registration number:

ChiCTR1800019551 

最近更新日期:

Date of Last Refreshed on:

2018-11-18 

注册时间:

Date of Registration:

2018-11-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

精准椎间孔成型术治疗腰椎管狭窄 

Public title:

precise safety decompression via minimal invasive technique for treating lumbar spinal stenosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

精准椎间孔二次成型技术治疗腰椎侧方椎管狭窄的临床疗效分析 

Scientific title:

The effectiveness of precise safety decompression via two-time percutaneous lumbar foraminoplasty and percutaneous endoscopic lumbar decompression for lumbar lateral spinal canal stenosis 

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:

王玉 

研究负责人:

孔清泉 

Applicant:

Yu Wang 

Study leader:

Qingquan Kong 

申请注册联系人电话:

Applicant telephone:

+86 18349386881 

研究负责人电话:

Study leader's telephone:

+86 18980601954 

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:

76390458@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

kqqspine@126.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:

成都市武侯区国学巷37号 

研究负责人通讯地址:

成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan 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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

chengdu

单位(医院):

四川大学华西医院

具体地址:

成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

自筹经费 

Source(s) of funding:

by ourselves 

研究疾病:

腰椎管狭窄 

Target disease:

lumbar spinal stenosis 

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:

I期临床试验 

Study phase:

研究目的:

验证经椎间孔二次成型技术治疗侧方腰椎管狭窄的近期临床疗效 

Objectives of Study:

This study reports a new technique: precise safety decompression via two-time percutaneous lumbar foraminoplasty (TPLF) and percutaneous endoscopic lumbar decompression (PELD) for lumbar lateral spinal canal (LLSC) stenosis, and short-term clinical outcomes. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)症状为单根神经根症状:疼痛、麻木或运动功能障碍,伴或不伴腰痛;(2)完整获取影像学资料,并证实单节段侧隐窝狭窄,影像学特点与症状体征相吻合。并且同时存在盘黄间隙和骨性侧隐窝狭窄;狭窄诊断依据如下:盘黄间隙狭窄是通过椎管旁中央区域的MRI T2像矢状位(椎管前后径小于1mm);骨性侧隐窝狭窄是通过CT骨窗来判断(侧隐窝区前后径<3mm);如果出现影像学不典型,或责任节段不好判定,则通过硬膜外封闭来进一步明确责任节段;(3)症状明显(中度以上疼痛),保守治疗3个月疗效不满意;(4)自愿接受手术并随访6月以上。 

Inclusion criteria

(1) manifested as single nerve root symptom, such as single side extremity pain, numb or weakness, with or without LBP; (2) with full preoperative and postoperative radiological information. The method of distinguishing stenotic zone has been described in previous study[8]. Stenosis in zone 1 was diagnosed by sagittal T2-weighted MRI scans through paracentral region: the anteroposterior distance less than 1 mm. Stenosis in zone 2 was diagnosed by axial bone window CT scans: the anteroposterior distance in lateral recess region less than 3 mm. The radiological diagnosis should be identical to clinical symptom. Preoperative blocking of the nerve root could be applied in some intractable cases; (3) with obvious symptom (preoperative leg pain Visual Analogue Score (VAS) score over 6) after over 3 months invalid conservative treatment; (4) To be informed consent for our study and agreed to accomplish all follow-up. 

排除标准:

(1)术前动力位腰椎X线片提示腰椎节段性不稳定;(2)术前影像学检查MRI/CT示腰椎管狭窄类型为中央型椎管狭窄;(3)单纯的腰椎间盘突出症,无发育性和(或)退变性椎管狭窄因素;(4)重度腰椎滑脱,多节段椎管狭窄症;(5)高髂嵴(标准正侧位片显示髂嵴联系位于L4椎体的下1/4 以上,影响L5-S1椎间孔穿刺者;(6)有手术禁忌症,无法行手术治疗的病例 

Exclusion criteria:

(1) have lumbar segmental instability indicated by preoperative lumbar flexion-extension X-Ray; (2) combined with lumbar central canal stenosis; (3) was diagnosed as pure lumbar disc herniation; (4) high-grade lumbar spondylolisthesis with multi-level spinal stenosis; (5) with high iliac crest, the peak of iliac crest exceed lower quarter of L4 vertebral body, which hindered puncture in L5/S1; (6) with surgical contraindication. 

研究实施时间:

Study execute time:

From2018-11-21To 2019-12-13 

征募观察对象时间:

Recruiting time:

From2018-11-21To 2019-04-26 

干预措施:

Interventions:

组别:

Group 1

样本量:

50

Group:

Group 1

Sample size:

干预措施:

precise decompression

干预措施代码:

Intervention:

precise decompression

Intervention code:

组别:

Group 2

样本量:

50

Group:

Group 2

Sample size:

干预措施:

TESSYS

干预措施代码:

Intervention:

TESSYS

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

VAS scores

指标类型:

主要指标 

Outcome:

VAS scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

macnab score

指标类型:

主要指标 

Outcome:

macnab 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:

satisfactory rate

指标类型:

主要指标 

Outcome:

satisfactory rate

Type:

Primary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

N/A

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
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

公示

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

public showing

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:

excel软件

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

excel software

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-11-18
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