A Novel Patient-Specific Navigational Template for Cervical Pedicle Screw Placement

Study Design. Prospective trial. Objective. To develop and validate a novel, patient-specific navigational template for cervical pedicle placement. Summary of Background Data. Owing to the narrow bony anatomy and the proximity to the vertebral artery and the spinal cord, cervical instrumentation procedures demand the need for a precise technique for screw placement. Patient. Specific drill template with preplanned trajectory has been thought as a promising solution for cervical pedicle screw placement. Methods. Patients with cervical spinal pathology (n = 25) requiring instrumentation were recruited. Volumetric CT scan was performed on each desired cervical vertebra and a 3-dimensional reconstruction model was generated from the scan data. Using reverse engineering technique, the optimal screw size and orientation were determined and a drill template was designed with a surface that is the inverse of the posterior vertebral surface. The drill template and its corresponding vertebra were manufactured using rapid prototyping technique and tested for violations. The navigational template was sterilized and used intraoperatively to assist with the placement of cervical screws. In total, 88 screws were inserted into levels C2-C7 with 2 to 6 screw in each patient. After surgery, the positions of the pedicle screws were evaluated using CT scan and graded for validation. Results. This method showed its ability to customize the placement and the size of each screw based on the unique morphology of the cervical vertebra. In all the cases, it was relatively very easy to manually place the drill template on the lamina of the vertebral body during the surgery. The required time between fixation of the template to the lamina and insertion of the pedicle screws was about 80 seconds. Of the 88 screws, 71 screws had no deviation and 14 screws had deviation <2 mm, 1 screw had a deviation between 2 to 4 mm and there were no misplacements. Fluoroscopy was used only once for every patient after the insertion of all the pedicle screws. Conclusion. The authors have developed a novel patient-specific navigational template for cervical pedicle screw placement with good applicability and high accuracy. This method significantly reduces the operation time and radiation exposure for the members of the surgical team. The potential use of such a navigational template to insert cervical pedicle screws is promising. This technique has been clinically validated to provide an accurate trajectory for pedicle screw placement in the cervical spine.