Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment

February 26, 2014 updated by: Diego da Silva Collares, Hospital Ortopedico de Passo Fundo
Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The treatment of burst fractures of the thoracic and lumbar spine is still a subject of much discussion and debate in the literature, especially in patients without neurological deficit. Most authors recommend surgical treatment for patients whose fracture shows signs of instability: 50% loss of vertebral body height, kyphosis with more than 30 degrees, involvement of more than 50% of the spinal canal. The authors advocate that this type of treatment uses the shorter hospital stay, early patient mobility, better kyphosis correction, the possibility of spinal canal decompression and prevention of neurological deterioration, as arguments in its favor.However, observational studies in patients without neurological deficit, showed no difference in long-term functional outcomes in patients with this type of injury, regardless of the type of treatment used (surgical or conservative). This study will express the clinical results and morphological changes of the thoracic and lumbar spine, at a minimum follow-up of 24 months, comparing the findings of the patients undergoing surgical treatment with those found in undergoing conservative treatment.

Study Type

Observational

Enrollment (Actual)

25

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

  • Brazil
    • RS
      • Passo Fundo, RS, Brazil, 99010080
        • Hospital Ortopedico de Passo Fundo

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

22 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Surgical treatment Group: 14 samples Conservative Treatment Group: 11 samples

Description

Inclusion Criteria:

  • Patients with thoracic or lumbar burst fracture, without neurological lesion treated by the principal investigator of the study and periodically monitored in the Service of the researcher, Orthopedic Hospital of Passo Fundo, with minimum follow-up of 24 months fracture.

Exclusion Criteria:

  • Patients with neurological deficit or who have left before 24 months the follow-up.

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
Conservative Treatment
Eleven patients underwent conservative treatment with Brace.
Device: Brace
Toracolumbar imobilization
Other Names:
  • Jewett
  • Putti
Surgical Treatment
Fourteen patients who underwent surgical treatment (arthrodesis).
Procedure: Arthrodesis
Posterior approach to toracolumbar spine fusion.
Other Names:
  • TLIF
  • PLIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)
Time Frame: Over Two Years
Retrospective review of medical records and imaging studies (radiographs and CT scans) of 30 patients without neurological deficit, with fractures of the thoracic and lumbar burst-type, in the archives of the Orthopedic Hospital of Passo Fundo, in the period between 2002 to 2011 submitted the clinical follow-up or post-operative periodical by the principal investigator of the study. The fractures, of the selected patients will be classified according to Magerl et al. (AO). Minimum follow-up is 24 months. It should be emphasized that all patients underwent at follow-up, the measurement of visual analog pain scale (VAS), the SF36 quality of life questionnaire, radiographic measurements of kyphosis, collapse and narrowing of the spinal canal. The clinical results obtained with conservative and surgical treatment will be compared and correlated with the morphological changes presented by the fractured vertebra.
Over Two Years

Collaborators and Investigators

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

Sponsor

Hospital Ortopedico de Passo Fundo

Investigators

  • Principal Investigator: Diego S Collares, MD, Hospital Ortopedico de Passo Fundo
  • Study Director: Rodrigo A Tisot, MD, Hospital Ortopedico de Passo Fundo
  • Principal Investigator: Andrius Berardi, MD, Hospital Ortopedico de Passo Fundo

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

March 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 314151 (Registry Identifier: Fratura Explosão)

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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