Pedicle screw fixation is an effective and reliable method for achieving stabilization in lumbar degenerative disease. The procedure carries a risk of violating the spinal and neural canal which can lead to nerve injury. This audit examines the accuracy of screw placement using intra-operative image guidance. Retrospective audit of patients undergoing lumbar pedicle screw fixation using image guidance systems over an 18-month period. Case records were reviewed to identify complications related to screw placement and post-operative CT scans reviewed to study the accuracy of screw position. Of the 98 pedicle screws placed in 25 patients, pedicle violation occurred in 4 screw placements (4.1%). Medial or inferior breach of the pedicle cortex was seen in 2 screws (2%). Nerve root injury as a consequence of this violation was seen in one patient resulting in irreversible partial nerve root dysfunction. Mean set up time for the guidance system was 42 minutes. The mean operative time was 192 minutes. Violation of either the medial or inferior pedicle cortex during placement of fixation screws is a rare, but potentially serious complication bearing lasting consequences. Image-guided placement can be helpful and possibly improve accuracy; particularly in patients with distorted spinal anatomy

The use of intraoperative navigation and robotic surgery for minimally invasive lumbar fusion has been increasing over the past decade. The aim of this study is to evaluate postoperative clinical outcomes, intraoperative parameters, and accuracy of pedicle screw insertion guided by intraoperative navigation in patients undergoing lumbar interbody fusion for spondylolisthesis. Patients who underwent posterior lumbar fusion interbody using intraoperative 3D navigation since December 2021 were included. Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and Short Form Health Survey-36 (SF-36) were assessed preoperatively and postoperatively at 1, 3, and 6 months. Screw placement accuracy, measured by Gertzbein and Robbins classification, and facet joint infringement, measured by Yson classification, were assessed by intraoperative Cone Beam CT scans performed at the end of instrumentation. Finally, operation time, intraoperative blood loss, hospital stay, and screw insertion time were evaluated. This study involved 50 patients with a mean age of 63.7 years. VAS decreased from 65.8±23 to 20±22 (p<.01). ODI decreased from 35.4%±15 to 11.8%±14 (p<.01). An increase of SF-36 from 51.5±14 to 76±13 (p<.01) was demonstrated. The accuracy of “perfect” and “clinically acceptable” pedicle screw fixation was 89.5% and 98.4%, respectively. Regarding facet violation, 96.8% of the screws were at grade 0. Finally, the average screw insertion time was 4.3±2 min, hospital stay was 4.2±0.8 days, operation time was 205±53 min, and blood loss was 169±107 ml. Finally, a statistically significant correlation of operation time with hospital stay, blood loss and placement time per screw was found. We demonstrated excellent results for accuracy of pedicle screw fixation and violation of facet joints. VAS, ODI and SF-36 showed statistically significant improvements from the control at one month after surgery. Navigation with intraoperative 3D images represents an effective system to improve operative performance in the surgical treatment of spondylolisthesis

Summary Statement. Incorrect pedicle screw placement can lead to neurological complications. Practice outside the operating room on realistic bone models, with force feedback, could improve safety. Pedicle forces in cadaveric specimens are reported, to support development of a training tool for residents. Introduction. Inserting screws into the vertebral pedicles is a challenging step in spinal fusion and scoliosis surgeries. Errors in placement can lead to neurological complications and poor mechanical fixation. The more experienced the surgeon, the better the accuracy of the screw placement. A physical training system would provide orthopaedic residents with the feel of performing pedicle cannulation before operating on a patient. The proposed system consists of realistic bone models mimicking the geometry and material properties of typical patients, coupled with a force feedback probe. The purpose of the present study was to determine the forces encountered during pedicle probing to aid in the development of this training system. Methods. We performed two separate investigations. In the first study, 15 participants (9 expert surgeons, 3 fellows, 3 residents) were asked to press a standard pedicle awl three times onto a mechanical scale, blinded to the force, demonstrating what force they would apply during safe pedicle cannulation and during unsafe cortical breach. In the second study, three experienced surgeons used a standard pedicle awl fitted with a one-degree of freedom load cell to probe selected thoracolumbar vertebrae of eight cadaveric specimens to measure the forces required during pedicle cannulation and deliberate breaching, in randomised order. A total of 42 pedicles were tested. Results. Both studies had wide variations in the results, but were in general agreement. Cannulation (safe) forces averaged approximately 90 N (20 lb) whereas breach (unsafe) forces averaged approximately 135–155 N (30–35 lb). The lowest average forces in the cadaveric study were for pedicle cannulation, averaging 86 N (range, 23–125 N), which was significantly lower (p<0.001) than for anterior breach (135 N; range, 80–195 N); medial breach (149 N; range, 98–186 N) and lateral breach (157 N; range, 114–228 N). There were no significant differences among the breach forces (p>0.1). Cannulation forces were on average 59% of the breach forces (range, 19–84%) or conversely, breach forces were 70% higher than cannulation forces. Discussion. To our knowledge, axial force data have not previously been reported for pedicle cannulation and breaching. A large range of forces was measured, as is experienced clinically. Additional testing is planned with a six-degree-of-freedom load cell to determine all of the forces and moments involved in cannulation and breaching throughout the thoracolumbar spine. These results will inform the development of a realistic bone model as well as a breach prediction algorithm for a physical training system for spine surgery. The opportunity to learn and practice outside of the operating room, including learning from deliberate mistakes, should increase the confidence and comprehension of residents performing the procedure, enhance patient safety, reduce surgical time, and allow faster progression of learning inside the operating room

Pedicle screws fixation to stabilize lumbar spinal fusion has become the gold standard for posterior stabilization. However their positioning remain difficult due to variation in anatomical shape, dimensions and orientation, which can determine the inefficacy of treatment or severe damages to close neurologic structures. Image guided navigation allows to drastically decrease errors in screw placement but it is used only by few surgeons due to its cost and troubles related to its using, like the need of a localizer in the surgical scenario and the need of a registration procedure. An alternative image guided approach, less expensive and less complex, is the using of patient specific templates similar to the ones used for dental implants or knee prosthesis. Like proposed by other authors we decided to design the templates using CT scans. (slice thickness of 2.0 mm). Template developing is done, for each vertebra, using a modified version of ITK-SNAP 1.5 segmentation software, which allow to insert cylinders (full or empty) in the segmented images. At first we segment the spine bone and then the surgeon chose screw axes using the same software. We design each template with two hollow cylinders aligned with the axes, to guide the insertion in the pedicle, adding contact points that fit on the vertebra, to obtain a template right positioning. Finally we realize the templates in ABS using rapid prototyping. After same in-vitro tests, using a synthetic spine (by Sawbones), we studied a solution to guarantee template stability with simple positioning and minimizing intervention invasiveness. Preliminary ex-vivo animal testing on porcine specimens has been conducted to evaluate template performance in presence of soft-tissue in place, simulating dissection and vertebra exposure. For verification, the surgeon examined post-operative CT-scans to evaluate Kirschner wires positioning. During the ex-vivo animal test sessions, template alignment resulted easy thanks to the spinous process contact point. Their insertion required no additional tissue removal respect to the traditional approach. The positioning of contact points on vertebra's lamina and articular processes required just to shift the soft tissue under the cylinders bases. The surgeon in some cases evaluated false stable template positions since not each of the 4 contact points were actually in contact with the bone surface and tried the right position. CT evaluation demonstrate a positive results in 96.5% of the Kirschner wires implanted. Our approach allows to obtain patient specific templates that does not require the complete removal of soft tissue around vertebra. Guide positioning is facilitated thanks to the using of the spinous processes contact point, while false stable positions can be avoided using four redundant contact points. The templates can be used to guide the drill, the insertion of Kirschner in case of use of cannulated screws or to guide directly the screw. After these preliminary ex-vivo animal tests we obtained the authorization of the Italian Health Ministry to start the human study

Summary Statement. From a mechanical point of view, the clinical use of pedicle screws in the atlas is a promising alternative to lateral mass screws due to an increased biomechanical fixation. Introduction. The most established surgical technique for posterior screw fixation in the atlas (C1) is realised by screw placement through the lateral mass [1]. This surgical placement may lead to extended bleeding from the paravertebral venous plexus as well as a violation of the axis (C2) nerve roots [1]. Using pedicle screws is an emerging technique which utilises the canal passing through the posterior arch enabling the use of longer screws with a greater contact area while avoiding the venous plexus and axis nerve roots. The aim of this ex vivo study was to investigate if pedicle screws in C1 bear the potential to replace the more common lateral mass screws. Therefore, the comparative biomechanical fixation strengths in terms of cycles to failure, stiffness, and removal torque were investigated. Methods. Nine C1 cadaveric vertebrae from donors aged 58.0 ± 11.1 years were separated, CT scanned (Mx8000 IDT 16, Philips Healthcare, DA Best, The NL) with a phantom, and stored at −22°C. Each vertebra received one lateral mass screw and one pedicle screw of the same size (diameter: 3.5 mm, length: 26 mm, Synapse System, Synthes GmbH, Oberdorf, CH). The side on which each screw was placed into the vertebra was allocated based on BMD, age, gender, and testing order. Depending on the surgical technique the entry point varied; the pedicle screw entered through the posterior arch, and the lateral mass screw was inserted further inferior through the lateral mass. The screw tips converged to the same height and depth. Specimens were subjected to a sinusoidal, cyclic (0.5 Hz) fatigue loading at the screw head (858 Bionix®, MTS, Eden Prairie, MN). The peak compressive and tensile forces started from ±15 N and increased by 0.05 N every cycle. Testing was stopped at 5 mm displacement. Cycles to failure, displacement, initial and final cyclic stiffness were measured. After fatigue testing a surgeon evaluated each screw by hand for looseness. Final CT scans were taken and then the removal torque was measured. Results. The specimens were of normal bone quality (BMD = 226 ± 69.0 mgHA/cm. 3. ). The pedicle screw technique consistently and significantly out-performed the lateral mass technique in cycles to failure (p=0.001, r. 2. =0.48), initial stiffness (p=0.01, r. 2. =0.29), end stiffness (p=0.005, r. 2. =0.18), and removal torque (∗p=0.05, r. 2. =0.18). After testing only 33% of pedicle screws were loose compared to 100% of lateral mass screws. Discussion. Utilizing the C1 posterior arch, the pedicle screws were able to withstand a 32% higher toggle force than the lateral mass screws while maintaining a higher stiffness throughout and after testing. The advantages likely arise due to an increased depth into the bone and the smaller canal width. Due to the fixation benefits in the atlas, the clinical use of pedicle screws is a promising alternative to lateral mass screws. Funding from the State of Hamburg and the Marie Curie ITN project, SpineFX, is kindly acknowledged. The authors thank Synthes GmbH for providing the screws

Background. The overall incidence of neurological symptoms attributed to lumbar misplaced screws has been described to occur in 3.48% of patients undergoing surgery. These lumbar radicular neurological lesions are undetected with conventional intraoperative neurophysiological and radiological controls. The hypothesis of this study was that direct stimulation of the pedicle screw after placement in the lumbar spine may not work as well as for screws placed in the thoracic pedicles. A more suitable method for the lumbar spine could be the stimulation of the pedicle track with a ball-tipped probe. Methods. Comparative observational study on the detection of malpostioned lumbar pedicle screws using two different techniques in two different periods: t-EMG screw stimulation (2011–2012) and track stimulation (2013–2014). A total of 1440 lumbar pedicle screws were placed in 242 patients undergoing surgery for vertebral deformities in the last four years (2011–2014). In the first two years, 802 lumbar screws were neuromonitored using t-EMG during. In the last two years, 638 screws were placed after probe stimulation of the pedicle track. Standardised t-EMG conventional registration and fluoroscopy were afterwards performed in all cases. Results. Six patients (4.4%) in the t-EMG group without signs of screw misplacement developed radicular pain. After checking with CT scan, a caudal prominence of the screw at the inferior aspect of the pedicle was detected in 7 screws (0.9%) and they were removed. After removal, probe stimulation was performed at the middle track showing abnormal thresholds (3.9–9.7mA). In the second group (track stimulation), 11 cases (10.8%) had thresholds below 7 mA. In these cases, the intrapedicular route was changed. None of these 106 patients presented postoperative radiculopathy and CT scans showed that all screws were well positioned. Conclusions. The t-EMG stimulation of lumbar pedicle screws offer some false negatives cases. However, the record in the middle pedicle track is able to detect misplaced screws and prevent the development of lumbar radiculopathy. Therefore, systematic pedicle track stimulation is strongly recommended in the lumbar spine. Level of Evidence. Level III

Objectives

Intramedullary fixation is considered the most stable treatment for pertrochanteric fractures of the proximal femur and cut-out is one of the most frequent mechanical complications. In order to determine the role of clinical variables and radiological parameters in predicting the risk of this complication, we analysed the data pertaining to a group of patients recruited over the course of six years.

The aim of this biomechanical study was to investigate the role of the dorsal vertebral cortex in transpedicular screw fixation. Moss transpedicular screws were introduced into both pedicles of each vertebra in 25 human cadaver vertebrae. The dorsal vertebral cortex and subcortical bone corresponding to the entrance site of the screw were removed on one side and preserved on the other. Biomechanical testing showed that the mean peak pull-out strength for the inserted screws, following removal of the dorsal cortex, was 956.16 N. If the dorsal cortex was preserved, the mean peak pullout strength was 1295.64 N. The mean increase was 339.48 N (26.13%; p = 0.033). The bone mineral density correlated positively with peak pull-out strength.

Preservation of the dorsal vertebral cortex at the site of insertion of the screw offers a significant increase in peak pull-out strength. This may result from engagement by the final screw threads in the denser bone of the dorsal cortex and the underlying subcortical area. Every effort should be made to preserve the dorsal vertebral cortex during insertion of transpedicular screws.