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临床试验/NCT04032054
NCT04032054Unknown不适用

Comparison of Short Segment Mono-axial and Poly-axial Pedicle Screw Fixation for Thoracolumbar Fractures

Assiut University0 个研究点目标入组 50 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
The sagittal cobb's angel.

研究概览

简要总结

Comparison of short segment mono axial and poly axial pedicle screw fixation in thoracolumbar fractures regarding the best correction of the fracture and deformity and the maintenance of the correction.

详细描述

  • Thoracolumbar spine trauma represents the most common area fractured in the spine In a large series of 3,142 patients with traumatic spinal fractures, Wang et al., 2012, reported that 54.9% of the patients had fractures in the thoracolumbar spine. Patients with complete neurological deficits generally have thoracic fractures, possibly due to a small canal diameter when compared to the cervical or lumbar spine Although grouped together, TLST is comprised of injures to the more rigid thoracic spine (T1-T10), the flexible and transitional thoracolumbar junction (T11-L2), more susceptible to injuries, and the lumbar spine L3-5. Early diagnosis and adequate management may improve patients' outcome and decrease its inherent disability.(1)
  • Morphological classification of thoraco-lumbar fractures is based on the Magerl classification modified by the AOSpine Classification Group. For this evaluation radiograms and CT scans with multiplanar reconstructions are essential. In some cases additional MR images might be necessary.(2)
  • The goal of fracture treatment is to obtain and maintain a stable reduction and early mobilization. A secondary aim is to restore sagittal alignment which has gained increasing emphasis in the last decade.(3)
  • Posterior short segment fixation including the proximal and distal adjacent normal vertebrae is the most commonly performed surgery for the vast majority of thoracolumbar fractures, Posterior pedicle screw fixation has been shown to be simple, familiar, efficient, reliable, and safe for the reduction and stabilization of most fractures and remains the most popular technique.(4)
  • The aim of our study is to compare between monoaxial short segment pedicle screw fixation and polyaxial short segment pedicle screw fixation

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Thoracolumbar fractures D4 - L
  • Neurologically free.
  • Age of the patients to be from 20 to 60 years.
  • Type A3 and A4 according to the AO classification.

排除标准

  • Pathological or Osteoporotic fractures.
  • Lumbar degenerative diseases.
  • Multisegement spine fractures.
  • Poly traumatized patients

结局指标

主要结局

The sagittal cobb's angel.

时间窗: base line

the greatest angle at a particular region of the vertebral column, when measured from the superior endplate of a superior vertebra to the inferior endplate of an inferior vertebra.

次要结局

  • Anterior vertebral body height(base line)
  • Vertebral body angel(base line)

研究者

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

Islam Mohamed Abd El Hameed

Resident doctor

Assiut University

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