NCT03316703

Surgical Treatment of the Thoracolumbar Spine Fractures.

Status unknown NA Last updated 6 October 2021

What this trial tests

NA trial testing Conventional open surgery in Spinal Fracture in 60 participants. Status unknown.

Timeline

9 May 2018

Primary endpoint
10 December 2021

1 December 2023

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	9 May 2018
Primary completion	10 December 2021
Estimated completion	1 December 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Conventional open surgery
• Minimally invasive percutaneous surgery

Conditions studied

• Spinal Fracture — all drugs for Spinal Fracture →
• Traumatic Fracture — all drugs for Traumatic Fracture →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 65, any sex, with Spinal Fracture or Traumatic Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol.
   Defino HLA, Costa HRT, Nunes AA, Nogueira Barbosa M, et al · · 2019 · cited 17× · PMID 31472691 · DOI 10.1186/s12891-019-2763-1