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

Spine Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04032054
• Other study ID #: TL pedicular screws fixation
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: Islam mohamed, Bachelor's Degree
• Phone: +2001016329653
• Email: islammohamed846[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Spine Fracture

Intervention

Device:
• mono-axial and poly-axial screws
types of pedicular screws for thoracolumbar fractures fixation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sagittal cobb's angel.	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.	base line
Secondary	Vertebral body angel	the angel between upper and lower end plates of fractured vertebra	base line
Secondary	Anterior vertebral body height	distance between upper and lower end plates of same fractured vertebra	base line