NCT03269851

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2020

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

August 29, 2017

Last Update Submit

July 20, 2021

Conditions

Keywords

neurological deficit

Outcome Measures

Primary Outcomes (4)

  • To Measure spinal canal stenosis by cubic cm

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

    one year

  • To measure sagittal alignment of vertebral column by cobb angle

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

    one year

  • To measure vertebral body compression by cm

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

    one year

  • To measure type of fracture according to AO classification

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

    one year

Secondary Outcomes (1)

  • Proportion of Neurological deficit among patients with thoracolumbar spine fractures.

    one year

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Links

MeSH Terms

Conditions

Spinal FracturesNeurologic Manifestations

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, BoneNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammed G. Hassan

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 1, 2017

Study Start

November 1, 2018

Primary Completion

October 31, 2019

Study Completion

March 21, 2020

Last Updated

July 26, 2021

Record last verified: 2021-07

Locations