Open versus minimally invasive percutaneous surgery for surgical treatment of thoracolumbar spine fractures- a multicenter randomized controlled trial: study protocol

Helton L A Defino,Valéria Romero,Marcello Nogueira Barbosa,Altacílio A Nunes,Herton R T Costa

doi:10.1186/s12891-019-2763-1

Abstract

BackgroundThoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. Percutaneous minimally invasive surgery was introduced to reduce the pain associated with the open posterior approach and reduce the morbidity of the procedure by avoiding damage and dissection of the paravertebral muscles. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems.Methods/designsThis study is designed as a multi-center, randomized controlled trial of patients aged 18–65 years who are scheduled to undergo surgical posterior fixation. Treatment by the conventional open approach or percutaneous minimally invasive approach will be randomly assigned. The primary outcome measure is postoperative pain, which will be measured using the visual analogue scale (VAS). The secondary outcome parameters are intraoperative bleeding, postoperative drainage, surgery time, length of hospital stay, SF-36, EQ-5D-5 l, HADS, pain medication, deambulation after surgery, intraoperative fluoroscopy time, vertebral segment kyphosis, fracture vertebral body height, compression of the vertebral canal, accuracy of the pedicle screws, and breakage or release of the implants. Patient will be followed up for 1, 2, 3, 6, 12 and 24 months postoperatively and evaluated according to the outcomes using clinical and radiological examinations, plain radiographs and computed tomografy (CT).DiscussionSurgical treatment of thoracolumbar fractures by the open or percutaneous minimally invasive approach will be compared in a multicenter randomized study using similar types of fixation systems, and the results will be evaluated according to clinical and radiological parameters at 1, 2, 3, 6, 12 and 24 months of follow-up.Trial registrationClinicalTrial.gov approval number: 1.933.631, code: NCT03316703 in may 2017.

Highlights

Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures
Primary outcome In the analysis of the results regarding the outcomes, we will employ the relative risk (RR) and its 95% confidence interval and derived estimators, such as relative risk reduction (RRR), absolute risk reduction (ARR), risk difference (RD), number needed to treat (NNT), and number needed to damage (NND), emphasizing that in this clinical trial the intention-to-treat (ITT) principle will be used
Surgical treatment of thoracolumbar fractures traditionally has been performed mainly using an open midline approach involving fixation of the fracture with a pedicle screw-rod system associated with posterolateral bony fusion [4, 5]

Summary

Introduction

Thoracolumbar fractures are most frequent along the spine, and surgical treatment is indicated for unstable fractures. The goal of this study is to compare the surgical treatment of fractures of the thoracolumbar spine treated by the conventional open approach and the percutaneous minimally invasive approach using similar types of pedicle spine fixation systems. Conventional surgical treatment is performed by posterior fixation and arthrodesis of the injured vertebral segment using a pedicle fixation system with or without arthrodesis. This approach is performed via the open posterior approach over the midline [3,4,5]. The use of percutaneous pedicle screws is part of minimally invasive procedures of the spine, and they can be applied in surgical procedures that use a fixation system mainly for treatment of fractures, degenerative diseases and tumors [6, 7]

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