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Clinical Trials/NCT04032054
NCT04032054
Unknown
Not Applicable

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

Assiut University0 sites50 target enrollmentStarted: October 1, 2019Last updated:
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ConditionsSpine Fracture

Overview

Phase
Not Applicable
Enrollment
50
Primary Endpoint
The sagittal cobb's angel.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Detailed Description

  • 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

The sagittal cobb's angel.

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Islam Mohamed Abd El Hameed

Resident doctor

Assiut University

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