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

NCT ID: NCT02076607

Last Updated: 2014-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-07-31

Brief Summary

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Evaluate the correlation between the structural changes of fractures of the thoracic and lumbar spine burst type with clinical outcome of the treatment.

Detailed Description

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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.

Conditions

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Traumatic Burst Fractures of the Thoracic or Lumbar Spine. Normal Neurological Function

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Conservative Treatment

Eleven patients underwent conservative treatment with Brace.

Brace

Intervention Type DEVICE

Toracolumbar imobilization

Surgical Treatment

Fourteen patients who underwent surgical treatment (arthrodesis).

Arthrodesis

Intervention Type PROCEDURE

Posterior approach to toracolumbar spine fusion.

Interventions

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Arthrodesis

Posterior approach to toracolumbar spine fusion.

Intervention Type PROCEDURE

Brace

Toracolumbar imobilization

Intervention Type DEVICE

Other Intervention Names

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PLIF TLIF Jewett Putti

Eligibility Criteria

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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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Ortopedico de Passo Fundo

OTHER

Sponsor Role lead

Responsible Party

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Diego da Silva Collares

Spinal surgery fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego S Collares, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Ortopedico de Passo Fundo

Rodrigo A Tisot, MD

Role: STUDY_DIRECTOR

Hospital Ortopedico de Passo Fundo

Andrius Berardi, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Ortopedico de Passo Fundo

Locations

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Hospital Ortopedico de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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314151

Identifier Type: REGISTRY

Identifier Source: secondary_id

314151

Identifier Type: -

Identifier Source: org_study_id

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