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临床试验/NCT02436863
NCT02436863Unknown不适用

Influence of Laminoplasty and Internal Fixation on Vertebral Stability After Cervical, Thoracic and Lumbar Laminectomy for Tumor Resection

Southern Medical University, China1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Vertebral deformity

研究概览

简要总结

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.

详细描述

After laminectomy for removal of the cervical, thoracic and lumbar lesions, the recruited cases were randomly divided into two groups.

  1. The cases in group of laminoplasty, the lamina and spinous process was replanted to maintain the anatomical intactness of spinal canal.
  2. 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>=18 years) were enrolled.
  • The patients suffered with lesion inside the spinal canal, who underwent laminectomy to remove the lesion.
  • Pathology proved benign lesion.
  • Health condition of patients (KPS) >= 70.

排除标准

  • Children cases (<18 years) were excluded.
  • 2.The cases with pathological malignant tumors were excluded from this study.
  • KPS of patients < 70.

结局指标

主要结局

Vertebral deformity

时间窗: 3 years

次要结局

  • The influence of age on the vertebral deformity(3 years)

研究者

发起方
Southern Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuntao Lu

Professor

Southern Medical University, China

研究点 (1)

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