Patient-specific template-guided versus standard freehand lumbar pedicle screw implantation: a randomized controlled trial.

OBJECTIVE: Patient-specific template-guided (TG) pedicle screw placement currently achieves the highest reported accuracy in cadaveric and early clinical studies, with reports of reduced use of radiation and less surgical time. However, a clinical randomized controlled trial (RCT) eliminating potential biases is lacking. This study compares TG and standard freehand (FH) pedicle screw insertion techniques in an RCT. METHODS: Twenty-four patients (mean age 64 years, 9 men and 15 women) scheduled consecutively and independently from this study for 1-, 2-, or 3-level lumbar fusion were randomized to either the FH (n = 12) or TG (n = 12) group. Accuracy of pedicle screw placement, intraoperative parameters, and short-term complications were compared. RESULTS: A total of 112 screws (58 FH and 54 TG screws) were implanted in the lumbar spine. Radiation exposure was significantly less in the TG group (78.0 ± 46.3 cGycm2) compared with the FH group (234.1 ± 138.1 cGycm2, p = 0.001). There were 4 pedicle screw perforations (6.9%) in the FH group and 2 (3.7%) in the TG group (p > 0.99), with no clinical consequences. Clinically relevant complications were 1 postoperative pedicle fracture in the FH group (p > 0.99), 1 infection in the FH group, and 2 infections in the TG group (p > 0.99). There were no significant differences in surgical exposure time, screw insertion time, overall surgical time, or blood loss between the FH and TG groups. CONCLUSIONS: In this RCT, patient-specific TG pedicle screw insertion in the lumbar region achieved a high accuracy, but not better than a standardized FH technique. Even if intraoperative radiation exposure is less with the TG technique, the need for a preoperative CT scan counterbalances this advantage. However, more difficult trajectories might reveal potential benefits of the TG technique and need further research.