Standalone vertebroplasty versus posterior spinal fixatio

Not Applicable

Recruiting

Conditions: Clinical and radiological outcomes of standalone polymethylmethacrylate vertebroplasty versus posterior spinal fixation in the treatment of Patients with thoracolumbar burst fractures.
Stable burst fracture of unspecified thoracic vertebra, initial encounter for closed fracture
S22.001A

Registration Number: IRCT20180604039980N2

Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

Traumatic fracture
Age between 18 to 65 years
Burst fracture (40-60% height reduction, 20-40% canal compromise, kyphotic angulation 20 to 40 degrees)
Hemodynamic stability
Fracture below T6 level
Fracture in the last 2 weeks
Intact neurological exam
One or two level fractures

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spinal kyphosis. Timepoint: Preoperatively, early postoperatively and at 2 and 6 months after the surgery. Method of measurement: Measure the degree of spinal angulation.;Vertebral height. Timepoint: Preoperatively, early postoperatively and at 2 and 6 months after the surgery. Method of measurement: Measure the vertebral height.;Pain measurement. Timepoint: Two and six months after the operation. Method of measurement: The pain VAS (Visual Analogue Scale) is a unidimensional measure of pain intensity.;Low back pain disability measurement. Timepoint: Six months after the operation. Method of measurement: For measuring the ow back pain disability, the Oswestry Disability Index (ODI) is used.

Secondary Outcome Measures

Name	Time	Method
Pain score according to VAS (Visual Analogue Scale). Timepoint: Two and six months after the operation. Method of measurement: The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as no pain at all and pain as bad as it could be. The patient is asked to mark his pain level on the line between the two endpoints. The distance between no pain at all and the mark then defines the subject’s pain.;Oswestry Disability Index (ODI). Timepoint: Six months after the operation. Method of measurement: The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.