Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Laminectomy
2016年4月18日 更新者：Yuntao Lu、Southern Medical University, China
Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Cervical, Thoracic and Lumbar Laminectomy for Tumor Resection
The lesion located inside the spinal canal caused big trouble for clinical treatment.
Traditional laminectomy will destroy the biomechanics and influent the vertebral stability, which might cause kyphosis or other deformity.
So in some centers, neurosurgeries praised laminoplasty to make the intactness of posterior column.
They thought the laminoplasty can maintain the vertebral stability, and meanwhile the range of motion won't change so much.
However, some other scholars thought laminoplasty had no helps for stability because of the pseudarthrosis.
They preferred screw and stick system for internal fixation.
And we did meet several patients after laminectomy suffered with spinal deformity.
So we thought it is necessary for investigating the benefit of patients from laminoplasty and internal fixation.
研究概览
详细说明
After laminectomy for removal of the cervical, thoracic and lumbar lesions, the recruited cases were randomly divided into two groups.
- The cases in group of laminoplasty, the lamina and spinous process was replanted to maintain the anatomical intactness of spinal canal.
- On the other hand, the cases in internal fixation group, the pedicle screws were implanted, and tickets were used to complete the internal fixation.
During 3 years follow up, the vertebral deformity and the range of motion were investigated and evaluated. And in the meantime, the patient's age will also be analyzed to detect it's influence for the prognosis.
研究类型
观察性的
注册 (预期的)
120
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yuntao Lu, M.D., Ph.D
- 电话号码：+8613632101002
- 邮箱：lllu2000@163.com
研究联系人备份
- 姓名：Yiping Mo, Bachelor
- 电话号码：+8620-61641806
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510515
- 招聘中
- Nan fang hospital, Southern medical university
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接触：
- Chongyuan Xu, Ph.D
- 电话号码：+8620-62787238
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首席研究员：
- Yuntao Lu, M.D., Ph.D
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副研究员：
- Lin Pen, M.D.
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副研究员：
- Hai Wang, M.D., Ph.D
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副研究员：
- Jin Shi, Master
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
- Adult patients (>18 years) were enrolled.
- The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.
- The cases with pathological malignant tumors were excluded from this study.
- Health condition of patients (KPS) > 70.
描述
Inclusion Criteria:
- 1. Adult patients (>=18 years) were enrolled. 2. The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.
3. Pathology proved benign lesion. 4. Health condition of patients (KPS) >= 70.
Exclusion Criteria:
- 1. Children cases (<18 years) were excluded.
- 2.The cases with pathological malignant tumors were excluded from this study.
- 3. KPS of patients < 70.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Surgical perfomance (Laminoplasty)
After the lesions inside the spinal canal were surgical removed by laminectomy, the lamina and spinous process were replanted with titanium plates and screws.
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Two different surgical performances
|
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Surgical perfomance (Internal fixation)
After the lesions inside the spinal canal were surgical removed by laminectomy, the pedicle screws (Thoracic and lumbar vertebra) or lateral mass (Cervical vertebra) and sticks were used for internal fixation.
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Two different surgical performances
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Vertebral deformity
大体时间：3 years
|
3 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
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The influence of age on the vertebral deformity
大体时间：3 years
|
3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Yuntao Lu, M.D., Ph.D、Nanfang neurosurgery research institution
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年1月1日
初级完成 (预期的)
2018年12月1日
研究完成 (预期的)
2019年7月1日
研究注册日期
首次提交
2015年5月4日
首先提交符合 QC 标准的
2015年5月6日
首次发布 (估计)
2015年5月7日
研究记录更新
最后更新发布 (估计)
2016年4月19日
上次提交的符合 QC 标准的更新
2016年4月18日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Surgical performance的临床试验
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Arash Asher, MDVoxxLife招聘中