Clinical and radiological evaluation of cortical bone trajectory screw placement using patient-specific 3D templates: a multicentric prospective study.

PURPOSE: This study assessed the clinical safety and radiological efficacy of lumbosacral cortical pedicle screw placement using 3D printed patient specific templates in the lumbar spine.

METHODS

101 patients affected with degenerative disc(s) were enrolled in a multicentric study. We prospectively reviewed them in terms of radiation exposure, fusion rate, pedicle screw placement accuracy, clinical outcomes, and complication rates within 1 year after surgery. All screws were placed following the Cortical Bone Trajectory (CBT) using a 3D patient-specific guide (MySpine MC, Medacta).

RESULTS

At 1 year after surgery, 83.8% of patients demonstrated successful bone fusion. Significant improvements were observed in terms of disability, quality of life, and pain scores starting from day 1 after surgery. These improvements were sustainable after one year FU (p < 0.001). 416/428 (97,2%) of the screws were correctly placed without a cortical breach; 8 screws were classified as Grade I breach and 4 screws as Grade II. None of the breaches were clinically relevant. No loosening was reported. Complications during surgeries emerged in 3% of cases, but none were directly related to the use of CBT or to the use of the templates. One case of screw breakage was registered at the 7-month follow-up (0.2%).

CONCLUSIONS

These observations confirm the safety and effectiveness of patient-specific templates for CBT screw placement. The pre-operatively planned approach offers significant benefits in terms of reduced surgical invasiveness and patient outcomes.