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IRCT20180604039980N2 IRCT 2021-03-21 Shiraz University of Medical Sciences Standalone vertebroplasty versus posterior spinal fixation Clinical and radiological outcomes of standalone polymethylmethacrylate vertebroplasty versus posterior spinal fixation in the treatment of patients with thoracolumbar burst fractures 2021-04-09 anticipated 52 Complete https://irct.ir/trial/54508 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Fifty-two patients with thoracolumbar burst fractures are eligible for participation. The patients will randomly be allocated to two groups: group A or vertebroplasty (n=26), and group B or pedicular screw fixation (n=26), Randomization description: We will perform a prospective single-blind, randomized case-controlled trial in which 52 patients with thoracolumbar burst fractures will be enrolled. A general practitioner not only will assess 52 patients for eligibility, but also will evaluate baseline characteristics of eligible patients before randomization. Written informed consent will be obtained from all patients before operation. Eligible participants will be randomly assigned to two groups by opening sealed envelopes. The envelopes will be prepared beforehand and sorted randomly by using random allocation software (computerized random number generators). Randomization will be performed by a neurosurgery resident after the inclusion of the patients into the study by the surgeon. The patient will draw one of the two envelopes indicating surgical treatment with either Standalone Polymethylmethacrylate Vertebroplasty or Posterior Spinal. The patients will be randomly allocated to one of two groups: group I: standalone percutaneous cement augmentation in the fractured level(s) group II: posterior pedicular screw fixation in the fractured level(s), Blinding description: The data analysts and evaluators will be blind in this study, therefore it will be a single-blind study. N/A Clinical and radiological outcomes of standalone polymethylmethacrylate vertebroplasty versus posterior spinal fixation in the treatment of Patients with thoracolumbar burst fractures. Intervention 1: Intervention group: standalone polymethylmethacrylate vertebroplasty in the treatment of patients with thoracolumbar burst fractures. Intervention 2: Intervention group: posterior spinal fixation in treatment in the treatment of patients with thoracolumbar burst fractures. Yes - There is a plan to make this available What will be shared: Standalone polymethyl methacrylate (PMMA) vertebroplasty versus posterior spinal fixation in the treatment of burst thoracolumbar fractures with regard to clinical and radiologic outcomes. Radiologic outcomes include postoperative angulation and the correction of height reduction. The severity of postoperative pain is evaluated using the VAS.quality of life (QOL) is evaluated by a questionnaire based on the Oswestry Disability Index (ODI). When: After the publication of the results. To whom: All readers Conditions: All data of the patients will be available to the corresponding author of this proposal. For any query on the data of the patients in this study, you can contact Shiraz Neuroscience Research Center and pose your request to the corresponding author of this study. Where to obtain: Shiraz Neuroscience Research Center How to obtain: Contact Shiraz Neuroscience Research Center Comments:
public Dr. Majid Reza Farrokhi
Shiraz Neurosciences Research Center, Chamran Hospital, Chamran Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3623 4508 farrokhimr@yahoo.com Shiraz University of Medical Sciences scientific Dr. Majid Reza Farrokhi
Shiraz Neurosciences Research Center, Chamran Hospital, Chamran Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3623 4508 farrokhimr@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both S22.001A Stable burst fracture of unspecified thoracic vertebra, initial encounter for closed fracture Treatment - Surgery Treatment - Surgery Intervention group: standalone polymethylmethacrylate vertebroplasty in the treatment of patients with thoracolumbar burst fractures Intervention group: posterior spinal fixation in treatment in the treatment of patients with thoracolumbar burst fractures 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. 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. Shiraz University of Medical Sciences Approved 2019-05-08 Ethics committee of Shiraz University of Medical Sciences Central Building of Shiraz University of Medical Sciences, Zand Blvd., Shiraz Shiraz Fars Iran (Islamic Republic of)