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Completed

NCT Number: NCT02076607

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

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

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Key information

Age range

22 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Ortopedico de Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010080, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arthrodesis

Procedure

Posterior approach to toracolumbar spine fusion.

Other names: PLIF, TLIF

Brace

Device

Toracolumbar imobilization

Other names: Jewett, Putti

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospital Ortopedico de Passo Fundo

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2014
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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