European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Randomized Controlled Trial
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.
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. ⋯ I. These slides can be retrieved under Electronic Supplementary Material.