ClinicalTrials.gg
CompletedNCT03269851Updated Jul 26, 2021

Parameters of Neurological Deficit After Thoracolumbar Fractures

An observational study in SPINAL Fracture, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-26.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • SPINAL Fracture

Keywords

  • neurological deficit
03

In context

Spinal Fractures

144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.

This study's enrollment of 160 is above the median of 93 across 55 observational studies indexed under Spinal Fractures.

Browse Spinal Fractures studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • Patients with fracture type A0 according to AO classification.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
160 participants (actual)
Patient registry
No

Interventions

  • Radiationcomputed tomography

    ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures

06

What researchers measure

Primary outcomes

  1. To Measure spinal canal stenosis by cubic cm

    CT-Radiological parameters measured in patients with or without thoracolumbar fractures .

    Time frame: one year

  2. To measure sagittal alignment of vertebral column by cobb angle

    CT-Radiological parameters measured in patients with or without thoracolumbar fractures

    Time frame: one year

  3. To measure vertebral body compression by cm

    CT-Radiological parameters measured in patients with or without thoracolumbar fractures

    Time frame: one year

  4. To measure type of fracture according to AO classification

    CT-Radiological parameters measured in patients with or without thoracolumbar fractures

    Time frame: one year

Secondary outcomes

  1. 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.

    Time frame: one year

07

Study locations

1 site
  • Assiut University Hospital
    Assiut, Egypt
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Oct 2019, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 1, 2017
StartActual
Nov 1, 2018
Primary completionActual
Oct 31, 2019
CompletionActual
Mar 21, 2020
Last update
Jul 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03269851
Lead sponsor
Assiut University
Responsible party
Zamboo Safwat (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 1, 2017
Start date
Nov 1, 2018
Primary completion
Oct 31, 2019
Completion
Mar 21, 2020
Last update
Jul 26, 2021

Study contacts

Mohammed G. Hassan
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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