Parameters of Neurological Deficit After Thoracolumbar Fractures

SPINAL Fracture Clinical Trial

Official title:

Radiological Parameters Predicting Neurological Injury After Thoracolumbar Spinal Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269851
• Other study ID #: Neurological deficit
• Secondary ID: Thoracolumbar fr
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Fractures, Bone
• SPINAL Fracture
• Spinal Fractures

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

External Links

•   Correlation among canal compromise, neurologic deficit, and injury severity in thoracolumbar burst fractures.
•   CT scan prediction of neurological deficit in thoracolumbar burst fractures.
•   Neurologic injury and recovery in patients with burst fracture of the thoracolumbar spine.
•   Neurological deficit and canal compromise in thoracolumbar and lumbar burst fractures.
•   Relationship between traumatic spinal canal stenosis and neurologic deficits in thoracolumbar burst fractures.
•   The significance of thoracolumbar spinal canal size in spinal cord injury patients.