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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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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: |
否 |
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Approved by ethic committee: |
NO |
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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: |
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批准本研究的伦理委员会名称: |
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Name of the ethic committee: |
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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: |
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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 |
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Primary sponsor: |
West China Hospital, Sichuan University |
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研究实施负责(组长)单位地址: |
成都市武侯区国学巷37号 |
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Primary sponsor's address: |
37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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: |
自筹经费 |
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Source(s) of funding: |
by ourselves |
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研究疾病: |
腰椎管狭窄 |
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Target disease: |
lumbar spinal stenosis |
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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: |
治疗研究 |
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Study type: |
Treatment study |
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研究所处阶段: |
I期临床试验 | ||||||||||||||||||||||
Study phase: |
1 |
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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 |
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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. |
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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: |
非随机对照试验 |
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Study design: |
Non randomized control |
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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。 |
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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. |
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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 |
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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: |
从From2018-11-21至To 2019-12-13 |
征募观察对象时间: Recruiting time: |
从From2018-11-21至To 2019-04-26 |
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: |
正在进行 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): |
N/A |
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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): |
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Calculated Results after
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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 |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |