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

Abstract

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.

Biomechanical comparative study of midline cortical vs. traditional pedicle screw trajectory in osteoporotic bone

“…However, the additional time, the radiation exposure and the high cost for installation and maintenance, required space and personnel for operation, must be considered [ 12 , 26 , 32 ]. In this context the use of a patient specific screw placement guide with a preplanned screw trajectory has been considered as a promising approach [ 6 , 15 , 19 – 21 , 31 , 35 , 38 ].…”

Accuracy of Lumbosacral Pedicle Screw Placement in Dogs: A Novel 3D Printed Patient-Specific Drill Guide versus Freehand Technique in Novice and Expert Surgeons

“…In the medical literature, accuracy has been determined using specialized software that measures surface deviation, 32 but a grading system is also still used as a sole assessment of accuracy. 33 34 After taking the above in consideration, we adopted the grading system used by Chen and colleagues, which determines the ratio of the screw diameter to the implant corridor width. The overall accuracy in our study was lower compared with previous studies, which can be explained by the variety of study designs and a stricter grading system used in this study.…”

Comparison of Safety and Perioperative Outcomes Between Patient-specific Template-Guided and Fluoroscopic-Assisted Freehand Lumbar Screw Placement Using Cortical Bone Trajectory Technique

“…10 On the contrary, a randomized controlled study of 24 cases with lumbar pedicle screw implantation by Spirig et al reported that radiation exposure was 67% lower in the template-guided technique when compared with the freehand technique, with no significant difference in screw accuracy, operative time, and blood loss, which were inconsistent with the results of the present study. 11 This discrepancy might be due to two reasons as they mentioned: (1) the use of simple screw trajectory by highly experienced surgeons and (2) need for extensive dissection and meticulous removal of soft tissue to ensure proper fit of the template. In contrast to template guide for standard pedicle screw trajectory with convergent drill tubes, CBT template guide with divergent drill tubes is theoretically low profile and can be easily installed without additional surgical exposure.…”

“…Patient-specific template guide technique for pedicle screw insertion has reportedly not only improved screw placement accuracy, but also reduced operative time, screw placement time, blood loss, and intraoperative radiation exposure, compared to freehand fluoroscopic-assisted technique. [9][10][11] With regard to the template-guided CBT technique, cadaveric and clinical studies have reported highly accurate screw placement ranging from 2.5% to 9.4% without any cortical breach. [12][13][14][15][16] However, there is no study that can compare it to the standard technique, and little is known about its practical impact.…”