Surgical Treatment of Fractures of the Dorso-lombar Spine

April 16, 2024 updated by: Zied Mansi, Ibn Jazzar Hospital
Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rarely the vital prognosis .

The thoracolumbar spine has an extended transition zone between the tenth thoracic vertebra (T10) and the second lumbar vertebra (L2): the thoracolumbar hinge which, given its particular anatomical situation between a poorly mobile thoracic segment and a dynamic lumbar segment, is the predilection for occurrence of fractures and dislocations .

The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads.

The analysis of the lesion mechanism and its consequences depends on the understanding of the classification of these lesions which are essential for therapeutic conduct .

Surgical treatment constitutes a key element in the management strategy for these fractures

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kairouan, Tunisia, 3190
        • IBN jazzar hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

80 cases of surgically treated thoracolumbar spine fractures

Description

Inclusion Criteria:

  • the files of patients hospitalized for a recent fracture of the thoracolumbar spine within 12 months

Exclusion Criteria:

  • Files with insufficient follow-up, patients lost to follow-up. patients presenting: A pathological fracture. Osteoporotic collapse. Material and Methods 3 Staged trauma to the spine. A fracture due to ankylosing spondylitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
80 cases of thoracolumbar spine fractures
Some patients had osteosynthesis using a long construct, others had osteosynthesis using a short construct. Short constructs designated constructs only taking one level above and one level below the injury level (the fractured vertebra was not always included in the construct). The montages taking more than one level above or below the lesion were considered to be a long montage. Osteosynthesis is carried out using Cotrel Dubousset type rods and screws.
Other Names:
  • Arthrodesis
  • Release gestures
  • First approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age (in years)
Time Frame: from enrollment to the end of treatment at 4 years
average age of our patients was 38.25 years with extremes of 16 years and 68 years
from enrollment to the end of treatment at 4 years
Sex
Time Frame: from enrollment to the end of treatment at 4 years
Our series is characterized by a significant male predominance, it included 47 men (58.75%) and 33 women (41.25%), with a sex ratio of 1.42
from enrollment to the end of treatment at 4 years
Neurological status ( Frenkel classification)
Time Frame: from enrollment to the end of treatment at 4 years
3 Frankel A patients, 1 Frankel B patient, 6 Frankel C patients and 6 Frankel D
from enrollment to the end of treatment at 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00001194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

further use of this informations for others group works

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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