Evaluation of a Three-Dimensional Printed Guide and a Polyoxymethylene Thermoplastic Regulator for Percutaneous Pedicle Screw Fixation in Patients with Thoracolumbar Fracture.

BACKGROUND This study aimed to evaluate the efficacy of a porous polyoxymethylene thermoplastic regulator combined with a three-dimensional (3D) printed template to guide pedicle needle insertion in patients undergoing percutaneous pedicle screw fixation (PPSF) for thoracolumbar fracture. MATERIAL AND METHODS Forty patients were randomly divided into group A, treated using a porous polyoxymethylene thermoplastic regulator combined with a 3D printed template, and group B, who underwent conventional PPSF. Data recorded included the number of pedicle screws successfully inserted on the first attempt, the number of attempts, the time to successful needle insertion, the total time of fluoroscopy, and the duration of surgery. The Visual Analogue Scale (VAS) and the Oswestry Disability Index (ODI) scores one day before surgery, and at day 1, day 7, month 1, and month 3 after surgery were recorded. The postoperative vertebral posterior kyphotic angle (KA) and the rate of change of KA were recorded. RESULTS Group A had a significantly increased total number of successful first insertions compared with group BV (P<0.05). Postoperative VAS and ODI scores of patients in both groups were significantly lower than before surgery (P<0.05), with no significant difference between the two groups at postoperative month 1 and month 3 (P>0.05). The postoperative vertebral posterior KA decreased significantly in both groups after surgery, with no significant difference between the two groups (P>0.05). CONCLUSIONS The use of a porous polyoxymethylene thermoplastic regulator combined with a 3D printed template may improve the success of pedicle insertion in patients undergoing PPSF.