Does Three-dimensional Printing Plus Pedicle Guider Technology in Severe Congenital Scoliosis Facilitate Accurate and Efficient Pedicle Screw Placement?
Authors: Luo Ming , Wang Wengang , Yang Ningning , Xia Lei 
Published: May 2019

Abstract

Background
Three-dimensional (3-D) printing offers the opportunity to create patient-specific guides for pedicle screw placement based on CT-generated models. This technology might allow for more-accurate placement of pedicle screws in patients with severe congenital scoliosis who have rotated vertebrae and small pedicles, but to our knowledge, this premise has not been tested.

Questions/purposes
(1) Is the use of 3-D printing and pedicle guider technology as or more accurate than the use of the freehand technique for pedicle-screw placement in patients with severe congenital scoliosis? (2) Does surgical time differ with the use of these guiders? (3) Are complications less common in patients treated with this new approach to pedicle-screw placement?

Methods
A prospective controlled study was conducted of patients with severe congenital scoliosis (major curve ≥ 90°) from June 2016 to June 2018. During this period, we treated 93 patients with congenital scoliosis; 32 had severe scoliosis with a major curve ≥ 90°. The patients were divided into a pedicle guider group (n = 15) and a control group (n = 17) based on their willingness to use pedicle guider technology, which was considered a research technology. With the numbers available, there were no between-group differences in terms of age, sex, BMI, or parameters related to curve severity or flexibility, and all patients in both groups had severe curves. Preoperative and postoperative low-dose CT scans were performed in the two groups. In the pedicle guider group, custom software was used to design the pedicle guider, and a 3-D printer was used to print a physical spinal model and pedicle guiders. The pedicle guiders were tested on the surface of the physical spinal model before surgery to ensure proper fit, and then used to assist pedicle screw placement during surgery. A total of 244 screws were implanted with the help of 127 pedicle guiders (254 guiding tunnels) during surgery in the PG group. Five predesigned pedicle guiders were abandoned due to an unstable match, and the success rate of assisted screw placement using a pedicle guider was 96% (244 of 254). The freehand technique was used in the control group, which relied on anatomic localization to place pedicle screws. The accuracy of pedicle screw placement was evaluated with CT scans, which revealed whether screws had broken through the pedicle cortex. We compared the groups in terms of accuracy (defined as unanticipated breaches less than 2 mm), surgical time, time to place pedicle screws, and screw-related complications.

Results
A higher proportion of the screws placed using pedicle guider technology were positioned accurately than were in the control group (93% [227 of 244] versus 78% [228 of 291]; odds ratio, 3.69 [95% CI, 2.09–6.50]; p<0.001). With pedicle guider use, operative time (296 ± 56 versus 360 ± 74; 95% CI, -111 to -17; p = 0.010), time to place all screws (92 ± 17 versus 118 ± 21; 95% CI, -39 to -12; p = 0.001), and mean time to place one screw (6 ± 1 versus 7 ± 1; 95% CI, -2 to 0; p = 0.011) decreased. One patient in the pedicle guider group and four in the control group experienced screw-related complications; the sample sizes and small number of complications precluded statistical comparisons.

Conclusions
In this small, preliminary study, we showed that the accuracy of the surgical technique using spinal 3-D printing combined with pedicle guider technology in patients with severe congenital scoliosis was higher than the accuracy of the freehand technique. In addition, the technique using pedicle guider technology appeared to shorten operative time. If these findings are confirmed in a larger study, pedicle guider technology may be helpful for situations in which intraoperative CT or O-arm navigation is not available.

Level of Evidence
Level II, therapeutic study.