Pedicle screw placement accuracy in robot-assisted versus image-guided freehand surgery of thoraco-lumbar spine (ROBARTHRODESE): study protocol for a single-centre randomized controlled trial.

ABSTRACT:

Background

Robotic spinal surgery may result in better pedicle screw placement accuracy, and reduction in radiation exposure and length of stay, compared to freehand surgery. The purpose of this randomized controlled trial (RCT) is to compare screw placement accuracy of robot-assisted surgery with integrated 3D computer-assisted navigation versus freehand surgery with 2D fluoroscopy for arthrodesis of the thoraco-lumbar spine.

Methods

This is a single-centre evaluator-blinded RCT with a 1:1 allocation ratio. Participants (n = 300) will be randomized into two groups, robot-assisted (Mazor X Stealth Edition) versus freehand, after stratification based on the planned number of pedicle screws needed for surgery. The primary outcome is the proportion of pedicle screws placed with

SUBMITTER: Aurouer N 

PROVIDER: S-EPMC10837855 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature