Clinical trial NCT04032054: Comparison of Short Segment Mono-axial and Poly-axial Pedicle Screw Fixation for Thoracolumbar Fractures
Official title: Comparison of Short Segment Mono-axial and Poly-axial Pedicle Screw Fixation for Thoracolumbar Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Fracture
Keywords: thoracolumbar fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population will include all the recruited patients with thoracolumbar spine fracture eligible for our study according to inclusion and exclusion criteria

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

Eligibility criteria: Inclusion Criteria:

* Thoracolumbar fractures D4 - L3.
* 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

Primary outcomes:
measure: The sagittal cobb's angel.
timeFrame: base line
Secondary outcomes:
measure: Vertebral body angel
timeFrame: base line
measure: Anterior vertebral body height
timeFrame: base line
Other outcomes:
Locations:
Study officials:
References: