Surgical Treatment of the Thoracolumbar Spine Fractures.

Summary

The thoracolumbar segment fractures are the most frequent along the spine, and surgical treatment is indicated in unstable fractures. Surgical treatment has been performed through the posterior fixation pedicle fixation systems, and where necessary complemented by decompression of the spinal arthrodesis and previous channel. Surgical treatment has been performed by conventional open approach through the posterior incision on the midline, and detachment and removal of paraspinal muscles to access the posterior vertebral elements. The percutaneous minimally invasive surgery was introduced in the context of spinal surgery to reduce the morbidity associated with conventional open approach. It has been reported the lowest bleeding intra- and postoperative period, less pain, shorter hospital stay, rehabilitation and return to work faster with less use of minimally invasive percutaneous approach of the spine. However, predominates in the literature of clinical case reports and few prospective and randomized clinical trials. The performance of prospective randomized clinical trials have been required for the evaluation of the benefits of minimally invasive surgery in the treatment of the thoracolumbar spine fractures. The objective of the study is to compare the surgical treatment of fractures of the thoracolumbar spine using the conventional open approach or minimally invasive percutaneous approach to the stabilization of the vertebral segment affected, and using similar type of pedicle spinal fixation system. Patients will be evaluated in the preoperative, postoperative, 1,2,3,6,12 and 24 months by parameters related to the perioperative (intraoperative bleeding, surgery time), clinical (VAS, SF-36, HADS, EQ-5D-5L), images (radiographs and computed tomography). The study results will impact the guidelines of the surgical treatment of thoracolumbar spine fractures and may indicate the advantages or disadvantages of using surgery through conventional open approach to minimally invasive percutaneous surgery.

Conditions

• Spinal Fracture
• Traumatic Fracture

Interventions

PROCEDURE

Conventional open surgery

Surgical treatment will be performed by stabilizing the fractured vertebral segment (proximal vertebra and vertebra distal to fractured vertebra and fractured vertebra) by means of a 6.5 mm or 6.5 mm diameter polyaxial pedicle screw system. In the fractured proximal and distal vertebrae to the vertebrae, screws will be used up to the vertebral body and fractured vertebra will use shorter screws that do not penetrate the vertebral body. In the fractured vertebra, single or bilateral pedicle screw will be used according to the degree of involvement of the pedicle of the fractured vertebra. The vertebral fixation system will be applied through the conventional open approach (group A).

PROCEDURE

Minimally invasive percutaneous surgery

Surgical treatment will be performed by stabilizing the fractured vertebral segment (proximal vertebra and vertebra distal to fractured vertebra and fractured vertebra) by means of a 6.5 mm or 6.5 mm diameter polyaxial pedicle screw system. In the fractured proximal and distal vertebrae to the vertebrae, screws will be used up to the vertebral body and fractured vertebra will use shorter screws that do not penetrate the vertebral body. In the fractured vertebra, single or bilateral pedicle screw will be used according to the degree of involvement of the pedicle of the fractured vertebra. The vertebral fixation system will be applied through the minimally invasive percutaneous approach (group B) according to allocation after randomization.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Helton LA Defino, MD, PhD. · Department of Orthopedics and Traumatology.University of Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-09

Primary Completion

2021-12-10

Completion

2023-12-01

Countries

• Brazil

Study Locations