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临床试验/NCT02638272
NCT02638272已完成不适用

Outcomes of Radical Debridement Versus no Debridement Under Different Surgical Procedures for the Treatment of Thoracic and Lumbar Spinal Tuberculosis

The Second Hospital of Anhui Medical University0 个研究点目标入组 74 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
主要终点
blood loss in milliliter

研究概览

简要总结

Whether radical debridement is necessary for the treatment of thoracic and lumbar tuberculosis is still questionable. The objective of this prospective randomized study was to compare the outcomes of radical debridement versus no debridement under different surgical procedures for the treatment of thoracic and lumbar tuberculosis.

详细描述

Seventy-four thoracic and lumbar tuberculosis patients with a neurological function of grade D and E underwent surgeries from January 2009 to January 2014. All patients were divided into group A and group B by taking the drawing of lots. In group A, radical debridement, bone graft and instrumentation were performed. In group B, isolated posterior instrumentation without debridement were performed in all cases and drainage of iliopsoas abscess via laparoscopy in 2 cases. The operative time, blood loss, visual analogue score (VAS), erythrocyte sedimentation rate (ESR), kyphotic angle, Frankel grading, fusion rate and complications were evaluated.

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
14 Years 至 67 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Frankel grading was grade D and E
  • Severe back pain
  • Abscess combined with high pressure symptoms
  • Larger sequestrum formation or sinus
  • Significant spinal instability.

排除标准

  • Frankel grading was grade A,B and C
  • Conservative treatment

结局指标

主要结局

blood loss in milliliter

时间窗: 5 years

The operative time in minutes

时间窗: 5 years

erythrocyte sedimentation rate (ESR) in mm/h

时间窗: 5 years

kyphotic angle in degree

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
The Second Hospital of Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qian Jun

Principal Investigator

The Second Hospital of Anhui Medical University

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