Riccardo Cecchinato, Pedro Berjano, Alberto Zerbi, Marco Damilano, Andrea Redaelli, Claudio Lamartina


July 2019, Volume 28, Issue 7, pp 1712 - 1723 Original Article Read Full Article 10.1007/s00586-019-05978-3

First Online: 20 April 2019

Pedicle screw insertion with patient-specific 3D-printed guides based on low-dose CT scan is more accurate than free-hand technique in spine deformity patients: a prospective, randomized clinical trial

Background

Screw misplacement incidence can be as high as 15–30% in spine deformity surgery, with possible devastating consequences. Some technical solutions to prevent misplacement require expensive devices. MySpineTM comprises a low-dose CT scan of the patient’s spine to build a virtual model of the spine to plan the screw trajectories and a 3D-printed patient-specific guide system to prepare the screw trajectories and to implant the screws in the vertebrae in order to increase reproducibility and safety of the implants. The aim of this open-label, single-center, prospective randomized clinical trial with independent evaluation of outcomes was to compare the accuracy of free-hand insertion of pedicle screws to MySpineTM 3D-printed patient-specific guides.

Methods

Twenty-nine patients undergoing surgical correction for spinal deformity were randomized to Group A (pedicle screws implantation with MySpineTM) or Group B (free-hand implantation). Group A received 297 pedicle screws, and Group B 243 screws. Forty-three screws in Group A crossed over to free-hand implantation. Screw position was graded according to Gertzbein in grades 0, A, B or C, with grades 0 or A considered as “safe area.” Total fluoroscopy dose and time were compared in six patients of each group.

Results

Comparing the two study groups, we observed a statistically significant difference between the two groups (p 

Level of evidence

I.

Graphical abstract

These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.]


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