Parameters of Neurological Deficit After Thoracolumbar Fractures

Completed

• Conditions: SPINAL Fracture

• Registration Number: NCT03269851
• Lead Sponsor: Assiut University

Brief Summary

To detect Radiological parameters affecting neurological injury after thoracolumbar spinal fractures.

Detailed Description

Thoracolumbar spine fractures are the most common spinal column fractures. High activity and lack of stability make it more prone to fractures.

Many studies have attempted to determine whether the neurological deficit in such fractures is related to spinal canal stenosis or other parameters observed on axial computed tomography (CT). However, this relationship remains controversial.

Few reports shed light on the relation between different imaging parameters like sagittal alignment, vertebral body compression, canal stenosis, and type of fracture according to AO classification with the severity of nerve damage.

These four radiographic parameters will be tested as expected risk factors for the neurological deficit in thoracolumbar fractures.

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2018-11-01
• Primary Completion: 2019-10-31
• Study Completion: 2020-03-21
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Any patient with Acute (within one month) thoracolumbar spine fracture above 18 years old with or without neurological deficit
2. In orthopaedics and trauma department of Assiut university hospital from 1st of November 2018 to 31 st of October 2019.

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Exclusion Criteria

• Patients younger than 18 years old.
• Patients suffering from preoperative neurological diseases that hinder our examination like peripheral neuropathy or previous strokes.
• Obtuned patients who cannot be properly examined like those with low GCS score.
• Patients with old thoracolumbar fractures more than one month duration.
• Patients with pathological spine fractures like those with osteoporosis and cancer metastasis.
• Patients with fracture type A0 according to AO classification.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Measure spinal canal stenosis by cubic cm	one year	CT-Radiological parameters measured in patients with or without thoracolumbar fractures .
To measure sagittal alignment of vertebral column by cobb angle	one year	CT-Radiological parameters measured in patients with or without thoracolumbar fractures
To measure vertebral body compression by cm	one year	CT-Radiological parameters measured in patients with or without thoracolumbar fractures
To measure type of fracture according to AO classification	one year	CT-Radiological parameters measured in patients with or without thoracolumbar fractures

Secondary Outcome Measures

Name	Time	Method
Proportion of Neurological deficit among patients with thoracolumbar spine fractures.	one year	Number of patients with neurological deficit to the total number of patients with thoracolumbar spine fractures.

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt