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