[Case-control study on accuracy and safety of patient-specific drill-guide templates used in scoliosis cases].

Objective: To evaluate the accuracy and safety of pedicle screw insertion with the aid of novel patient-specific drill-guide templates in scoliosis cases.
Methods: Ten patients with scoliosis were selected to participate in the research (the observation group) from December 2013 to December 2014. The data was obtained from CT scanning, and put into the computer to perform reconstruction of spine, simulation of pedicle screw insertion, and design of patient-specific drill-guide templates with software. The templates were made with rapid prototyping technique. After sterilization, the templates were used to aid the pedicle screw insertion intraoperatively. The blood loss, operation duration, change of creatinine level pre- and post-operation, and complications related to pedicle screw insertion were recorded. The location of pedicle screws were graded so as to evaluate the accuracy. A comparative study was then performed with the data of ten scoliosis cases operated with free-hand method during the same period (control group). There were 5 cases of idiopathic scoliosis and 5 cases of congenital scoliosis in the observation group, including 3 males and 7 females. Their average age was 11.9 years old (ranged, 4 to 18 years old), and the average Cobb angle of main curve was 54.9° (ranged, 42.1° to 78.4°). There were also 5 cases of idiopathic scoliosis and 5 cases of congenital scoliosis in the control group,including 2 males and 8 females. Their average age was 12.6 years old (ranged, 6 to 17 years old), and the average Cobb angle of main curve was 56.6° (ranged, 38.2° to 93.4°).
Results: A total of 167 pedicle screws were inserted intraoperatively, with 138 screws (82.6%) in grade I, 26 screws (15.0%) in grade II, 4 screws in grade III (2.4%), but no screws in grade IV according to the CT image. There were 29 (17.4%) screws perforated, and 163 (97.6%) screws could be accepted. In the control group, a total of 165 pedicle screws were inserted intraoperatively, with 98 screws (59.4%) in grade I, 39 screws (23.6%) in grade II, 21 screws in grade III (12.7%), and 7 screws in grade IV (4.2%). There were 67 (40.6%) screws perforated, and 137 (83.0%) screws could be accepted. The grade distribution of screw position, ratio of perforated and accepted screws were significantly different between the two groups respectively (Z=-5.013, P=0.000; χ2=9.347, P=0.002; χ2=20.242, P=0.000). The correction rate of Cobb angle were (74.1±10.0)% vs (69.7±17.6)%; blood loss were (455±447) ml vs (415±389) ml; operation duration were (163.5±53.7) min vs (164.0±48.7) min; and the changes of creatinine level pre- and post-operatively were (-5.3±3.2) μmol/L vs (-3.4±3.1) μmol/L; all above data had no significant differences respectively (t=0.696, P=0.496; t=0.214, P=0.833; t=0.022, P=0.983; t=1.375, P=0.192). There were no complications related to pedicle screw insertion in each group.
Conclusion: The novel patient-specific drill guide template can be used to assist the insertion of pedicle screws in scoliosis cases with much higher accuracy than that of freehand method and fair safety.