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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03269851
Other study ID # Neurological deficit
Secondary ID Thoracolumbar fr
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date March 21, 2020

Study information

Verified date July 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 21, 2020
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
computed tomography
ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures

Locations

Country Name City State
Egypt Assiut University Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary To Measure spinal canal stenosis by cubic cm CT-Radiological parameters measured in patients with or without thoracolumbar fractures . one year
Primary To measure sagittal alignment of vertebral column by cobb angle CT-Radiological parameters measured in patients with or without thoracolumbar fractures one year
Primary To measure vertebral body compression by cm CT-Radiological parameters measured in patients with or without thoracolumbar fractures one year
Primary To measure type of fracture according to AO classification CT-Radiological parameters measured in patients with or without thoracolumbar fractures one year
Secondary Proportion of Neurological deficit among patients with thoracolumbar spine fractures. Number of patients with neurological deficit to the total number of patients with thoracolumbar spine fractures. one year
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