Clinical trial NCT02076607: Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment
Official title: Thoracic And Lumbar Burst Fracture: Correlation Between Structural Changes And Clinical Outcome Of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Burst Fractures of the Thoracic or Lumbar Spine.
Normal Neurological Function
Keywords: vertebra
column
lumbar
toracica
fracture
burst
Lead sponsor: Hospital Ortopedico de Passo Fundo
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical treatment Group: 14 samples Conservative Treatment Group: 11 samples

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)
timeFrame: Over Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Hospital Ortopedico de Passo Fundo
state: RS
Study officials:
affiliation: Hospital Ortopedico de Passo Fundo
name: Diego S Collares, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Ortopedico de Passo Fundo
name: Rodrigo A Tisot, MD
role: STUDY_DIRECTOR
affiliation: Hospital Ortopedico de Passo Fundo
name: Andrius Berardi, MD
role: PRINCIPAL_INVESTIGATOR
References: