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

NCT02076607 | Completed

• 1 other identifier: 314151
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

vertebra; column; lumbar; toracica; fracture; burst

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conservative Treatment

Eleven patients underwent conservative treatment with Brace.

Device: Brace

Surgical Treatment

Fourteen patients who underwent surgical treatment (arthrodesis).

Procedure: Arthrodesis

Interventions

Arthrodesis PROCEDURE

Posterior approach to toracolumbar spine fusion.

Also known as: PLIF, TLIF

Surgical Treatment

Brace DEVICE

Toracolumbar imobilization

Also known as: Jewett, Putti

Conservative Treatment

Eligibility Criteria

• Age: 22 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Ortopedico de Passo Fundo: lead

Study Sites (1)

Hospital Ortopedico de Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010080, Brazil

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Arthrodesis; Braces

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Diego S Collares, MD

  Hospital Ortopedico de Passo Fundo

  PRINCIPAL INVESTIGATOR

• Rodrigo A Tisot, MD

  Hospital Ortopedico de Passo Fundo

  STUDY DIRECTOR

• Andrius Berardi, MD

  Hospital Ortopedico de Passo Fundo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Spinal surgery fellow

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 3, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

BR (1)