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

Normal Neurological Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076607
• Other study ID #: 314151
• Secondary ID: 314151
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: February 26, 2014
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Hospital Ortopedico de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 69 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Arthrodesis
Posterior approach to toracolumbar spine fusion.

Device:
• Brace
Toracolumbar imobilization

Locations

Country	Name	City	State
Brazil	Hospital Ortopedico de Passo Fundo	Passo Fundo	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ortopedico de Passo Fundo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and radiological outcome after two years of follow up: Pain (VAS), deformity (degrees) and quality of life (SF36 questionary)	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	No