Increased Radiation but No Benefits in Pedicle Screw Accuracy With Navigation versus a Freehand Technique in Scoliosis Surgery.

BACKGROUND: The clinical value of pedicle screws in spinal deformity surgery is well known; however, screw insertion is demanding and sometimes associated with complications. Navigation systems based on intraoperatively obtained three-dimensional (3-D) images were developed to minimize pedicle screw misplacements. However, there is a lack of data confirming superiority of navigation above other techniques. There are also concerns regarding increased radiation used during the procedure.

QUESTIONS/PURPOSES: The purposes of this study were (1) to compare accuracy of the two methods of pedicle screws placement: intraoperative 3-D image navigation versus a freehand technique in patients with idiopathic scoliosis; and (2) to assess the radiation dose received by patients with both methods.

METHODS: Between 2014 and 2016, 49 patients underwent posterior spinal fusion with all pedicle screw constructs for idiopathic scoliosis performed by two surgeons. The study design involved alternating the use of the freehand technique and navigation to position pedicle screws in consecutive patients, forming groups of 27 patients with 451 navigated screws and 22 patients with 384 screws positioned freehand. The two groups did not differ in age, sex, or magnitude of deformity. Two observers not involved in the treatment evaluated the position of the screws. The pedicle breach was assessed on intraoperatively obtained 3-D O-arm® scans according to a grading system: Grade 0 = no pedicle wall violation; Grade 1 = perforation ≤ 2 mm; Grade 2 = 2 to 4 mm; and Grade 3 = perforation > 4 mm. Grades 0 and 1 were considered properly positioned and Grades 2 and 3 represented malposition.

RESULTS: In terms of accuracy, we found no differences, with the numbers available, between the freehand and navigated groups in terms of the proportion of screws that were properly positioned (96% freehand and 96% in the navigation group, respectively; p = 0.518). Grade 3 pedicle screws were observed only in the freehand group and were all located in the upper thoracic spine. Patients undergoing navigated pedicle screw placement received a greater mean radiation dose than those whose screws were placed freehand (1071 ± 447 mGy-cm versus 391 ± 53 mGy-cm; mean difference, 680 mGy-cm; 95% confidence interval, 217-2053 mGy-cm; p < 0.001).

CONCLUSIONS: In patients with moderate idiopathic scoliosis undergoing primary surgery, we did not observe benefits of pedicle screw placement with CT-based navigation, but the patients experienced greater exposure to radiation.

LEVEL OF EVIDENCE: Level III, therapeutic study.