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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180604039980N2

Enrollment

Registered

2021-03-21

Start date

2021-04-09

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: Intervention group: standalone polymethylmethacrylate vertebroplasty in the treatment of patients with thoracolumbar burst fractures. Intervention 2: Intervention group: posterior sp

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Majid Reza Farrokhi

Shiraz University of Medical Sciences

farrokhimr@yahoo.com+98 71 3623 4508

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026