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临床试验/NCT03768167
NCT03768167已完成不适用

Posterolateral Corpectomy With Pyramesh Titanium Cage Reconstruction in Dorsolumber Metastatic Lesions

Sohag University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
(Quebec scale) to assess back pain in three years

研究概览

简要总结

The vertebral column represents the most common bony site for metastasis with an incidence ranged from 30% to 70% in patients with metastatic neoplasms. The dorsal spine carries the highest frequent site for metastasis all over the vertebral column followed by the lumber spine. These metastatic lesions are clinical entities that often necessitate a complex spinal decompression and anterior reconstruction. Posterolateral approaches alone allow for excellent decompression with transpedicular fixation and safe visualization of the neural elements for corpectomy and reconstruction so the investigators can avoid the complications that can be happened with the staged surgery.

Purpose: investigators' aim in the study is to report cases and evaluate investigators' approach for fixation and assess the postoperative period regarding pain improvement and neurological deficit.

详细描述

At neurosurgery department in Sohag faculty of medicine, Between August 2014 and August 2017, 26 patients with single dorsolumbar metastatic spinal lesions with vertebral body collapse underwent a single-stage, circumferential corpectomy and anterior spinal reconstruction with a pyramesh titanium cage via a midline, posterior and lateral approach. Investigators included in the study patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation. Metastatic work up was done for cases. Exclusion criteria include patients with more than one spinal metastases or extra-spinal metastasis, patients with other comorbidities as cardiac ill patients, patients with chronic renal failure and patients who received radiotherapy or chemotherapy within one year before surgery. A preoperative neurological assessment, full laboratory investigations were done. Investigators used the Quebec scale to assess the patients' improvement regarding pain, and muscle power scale to evaluate the motor.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
33 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with retropulsed fragment inside the canal that causes spinal cord compression with neurological manifestation.

排除标准

  • patients with more than one spinal metastases or extra-spinal metastasis.
  • patients with other comorbidities as cardiac ill patients, patients with chronic renal failure.
  • patients who received radiotherapy or chemotherapy within one year before surgery.

研究组 & 干预措施

patients with metastatic spinal lesions

Other

corpectomy

干预措施: Posterolateral corpectomy (Procedure)

结局指标

主要结局

(Quebec scale) to assess back pain in three years

时间窗: 3 years

(Quebec Scale) the lower scale the better is the pain

(muscle power grading scale) to evaluate motor power using in three years

时间窗: 3 years

(Muscle power grading) the higher the grade the better is the motor power

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ahmed salaheldin mohammed saro

Assistant professor of neurosurgery

Sohag University

研究点 (2)

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