The accuracy of pedicle screw placement is essential for successful spinal reconstructive surgery. The authors of several previous studies have described the use of image-based navigational templates for pedicle screw placement. These are designed based on a pre-operative computed tomographic (CT) image that fits into a unique position on an individual's bone, and holes are carefully designed to guide the drill or the pedicle probe through a pre-planned trajectory. The current study was conducted to optimise navigational template design and establish its designing method for safe and accurate pedicle screw placement. Thin-section CT scans were obtained from 10 spine surgery patients including 7 patients with adolescent idiopathic scoliosis (AIS) and three with thoracic ossification of the posterior longitudinal ligament (OPLL). The CT image data were transferred to the commercially available image-processing software and were used to reconstruct a three-dimensional (3D) model of the bony structures and plan pedicle screw placement. These data were transferred to the 3D-CAD software for the design of the template. Care was taken in designing the template so that the best intraoperative handling would be achieved by choosing several round contact surfaces on the visualised posterior vertebral bony structure, such as transverse process, spinous process and lamina. These contact surfaces and holes to guide the drill or the pedicle probe were then connected by a curved pipe. STL format files for the bony models with planned pedicle screw holes and individual templates were prepared for rapid prototype fabrication of the physical models. The bony models were made using gypsum-based 3D printer and individual templates were fabricated by a selective laser melting machine using commercially pure titanium powder. Pedicle screw trajectory of the bony model, adaptation and stability of the template on the bony model, and screw hole orientation of the template were evaluated using physical models. Custom-made titanium templates with adequate adaptation and stability in addition to proper orientation of the screw holes were sterilised by autoclave and evaluated during surgery. During segmentation, reproducibility of transverse and spinous processes were inferior to the lamina and considered inadequate to select as contact surfaces. A template design with more bone contact area might enhance the stability of the template on the bone but it is susceptible to intervening soft tissue and geometric inaccuracy of the template. In the bony model evaluation, the stability and adaptation of the templates were sufficient with few small round contact surfaces on each lamina; thus, a large contact surface was not necessary. In clinical patients, proper fit for positioning the template was easily found manually during the operation and 141/142 screws were inserted accurately with 1 insignificant pedicle wall breach in AIS patient. This study provides a useful design concept for the development and introduction of custom-fit navigational template for placing pedicle screws easily and safely

We present an analysis of manual and computer-assisted preoperative pedicle screw placement planning. Preoperative planning of 256 pedicle screws was performed manually twice by two experienced spine surgeons (M1 and M2) and automatically once by a computer-assisted method (C) on three-dimensional computed tomography images of 17 patients with thoracic spinal deformities. Statistical analysis was performed to obtain the intraobserver and interobserver variability for the pedicle screw size (i.e. diameter and length) and insertion trajectory (i.e. pedicle crossing point, sagittal and axial inclination, and normalized screw fastening strength). In our previous study, we showed that the differences among both manual plannings (M1 and M2) and computer-assisted planning (C) are comparable to the differences between manual plannings, except for the pedicle screw inclination in the sagittal plane. In this study, however, we obtained also the intraobserver variability for both manual plannings (M1 and M2), which revealed that larger differences occurred again for the sagittal screw inclination, especially in the case of manual planning M2 with average differences of up to 18.3°. On the other hand, the interobserver variability analysis revealed that the intraobserver variability for each pedicle screw parameter was, in terms of magnitude, comparable to the interobserver variability among both manual and computer-assisted plannings. The results indicate that computer-assisted pedicle screw placement planning is not only more reproducible and faster than, but also as reliable as manual planning

Background. Accurate insertion of pedicle screws in scoliosis patients is a great challenge for surgeons due to the severe deformity of thoracic and lumbar spine. Meanwhile, mal-position of pedicle screw in scoliosis patients could lead to severe complications. Computer-assisted navigation technique may help improving the accuracy of screw placement and reducing complications. Thus, this meta-analysis of the published researches was conducted concentrating on accuracy of pedicle screw placement and postoperative assessment in scoliosis patients using computer-assisted navigation technique. Methods. PubMed, Cochrane and Web of Science databases search was executed. In vivo comparative studies that assessed accuracy and postoperative evaluation of pedicle screw placement in scoliosis patients with or without navigation techniques were involved and analysed. Results. One published randomised controlled trial (RCT) and seven retrospective comparative studies met the inclusion criteria. These studies included 321 patients with 3821 pedicle screws inserted. Accuracy of pedicle screw insertion was significantly increased with using of navigation system, while average surgery time was not significantly different with non-navigated surgery. And Correction rate for scoliosis in navigated surgery was not significantly different with non-navigated surgery. Conclusions. Navigation technique does indeed improve the accuracy of pedicle screw placement in scoliosis surgery, without prolong the surgery time or decrease the deformity correction effect

Introduction. Pedicle screw fixation is considered gold standard as it provides stable and adequate fixation of all the three columns of spine. Mal-placement of screws in dorso-lumbar region, using fluoroscopic control only, varies from 15% to 30 %. The aim of this study was to determine whether accuracy of pedicle screw placement can be improved using CT based navigation technique. Material & methods. 15 patients with fracture of D12 in 4 patients, L1 in 6 patients, L2 in 4 patients, and L4 in 1 patient underwent pedicle screw fixation using CT based navigation. Each fracture was fixed with 4 pedicle screws, 2 each in one level above and one level below the fractured vertebrae. A total of 60 pedicle screws was inserted. A pre-operative 1mm slice planning CT scan was taken from two levels above to two levels below the fractured vertebrae. It was loaded into the workstation and pre-operative planning was made of screw trajectory and screw size i.e. thickness and length, according to the dimensions of the pedicle and vertebral body. Screws were then inserted using opto-electronic navigation system. Screw placement was analysed in all patients using post-operative CT scan and graded according to the Laine's system. Results. The average time for matching was 10.8 minutes and average time for screw insertion was 4.3 minutes (range 2-8 minutes). One screw in right sided pedicle of L2 perforated the lateral cortex (1.66%). There was no neuro-vascular complication. Conclusion. The incidence of a misplaced screw in the present study is only 1.66% which is much less than reported with conventional technique, reflecting enhanced accuracy with computer assisted navigation. Thus computer assisted navigation is a potent tool in the hands of a spine surgeon in improving the accuracy of pedicle screw placement

The use of cervical pedicle screws as anchors in posterior reconstruction surgery has not been widely accepted due to the neurological or vascular injury. We thus sought to investigate the accuracy of free-handed pedicle screw placement in the cervical and upper thoracic spine at the early stage of clinical application. Eight patients (five males and three females) were included in this study. Mean age was 63 years (31 to 78 years). There were three patients with rheumatoid arthritis, three with cervical fracture-dislocation, and two with spinal metastasis. Twenty-four pedicle screws (3.5 mm diameter: Vertex, Medtronic Sofamordanek) were placed into the pedicle from C2 to T2 level by free-handed technique2). Grade of breaching of pedicle cortex was divided into four groups (Grade 0–3). In addition, screw axis angle (SAA) were calculated from the horizontal and sagittal CT images and compared with pedicle transverse angle (PTA). Furthermore, perioperative complications were also examined. Our free-handed pedicle screw placement with carving technique is as follows: A longitudinal gutter was created at the lamina-lateral mass junction and then transverse gutter perpendicular to the longitudinal gutter was made at the lateral notch of lateral mass. The entry point of the pedicle screw was on the midline of lateral mass. Medial pedicle cortex through the ventral lamina was identified using the probes to create the hole within the pedicle. The hole was tapped and the screw was gently introduced into the pedicle to ensure the sagittal trajectory using fluoroscopy. In the transverse direction, 22 out of 24 screws (92%) were entirely contained within the pedicle (Grade 0). In contrast, only teo screws (8%) produced breaches less than half the screw diameter (Grade 1). In the sagittal direction, all screws were within the pedicle (Grade 0). Screw trajectories were not consistent with anatomical pedicle axis angle; the mean SAA were smaller than the mean PTA at all levels. The pedicle diameter ranged from 3.9 to 9.2 mm. The mean value gradually increased toward the caudal level. There were no neurological and vascular complications related to screw placement

Pedicle screws fixation to stabilise lumbar spinal fusion is the gold standard for posterior stabilisation. Pedicle screws are today positioned in free hand or under fluoroscopic guidance with an error from 20% up to 40–50%, which can determine the inefficacy of treatment or severe damages to close neurologic structures. Surgical navigation drastically increases screws placement accuracy. However its clinical application is limited due to cost reasons and troubles related to the presence of a localiser in the OR and the need to perform a registration procedure before surgery. An alternative image guided approach is the use of patient specific templates similar to the ones used for dental implants or knee prosthesis. Until now, the proposed solutions allow to guide the drill, and in some cases, as templates fit completely around vertebra, they require the complete removal of soft tissues on a large portion of the spine, so increasing intervention invasiveness. To reduce the soft tissue demolition, some authors proposed a fitting based on small “V shape” contact points, but these solutions can determine instability of the template and the reacting of wrong stable positions.

In our solution, after spine CT acquisition, each vertebra is segmented using a modified version of ITK-SNAP software, on which the surgeon plans screws positioning and finally the template is designed around the chosen trajectories, using a tool which allows to insert cylinders (full or empty) in the segmented images. Each template, printed in ABS, contains two hollow cylinders, to guide the screws, and multiple contact points on the bone surface, for template stabilisation.

We made an in-vitro evaluation on synthetic spine models (by Sawbones) to study different template designs. During this first step an ongoing redesign allowed to obtain an optimal template stability and an easy template positioning to minimise the intervention invasiveness. A first contact point, which fits on the sides of the spinous process, is used to simplify template alignment. The other 4 contact points, which consists of cylinders (diameter 5 mm), fit exactly on spine surface in correspondence to the vertebra's lamina and articular processes to stabilise the template in an unique position. Templates can be used to guide not only the drill, but also Kirschner wires, to guide cannulated screws. After the Kirschner wires insertion the template can be dismounted for its removal (the direction of the kirschner wires are not parallel).

After the definitive template design an ex-vivo animal test on 2 porcine specimens has been conducted to evaluate template performance in presence of soft-tissue in place. The specimens have been scanned with CT, we realised a total of 14 templates and we performed the insertion of 28 Kirschner wires. We evaluated that after the soft tissue dissection and the bone exposure, the template can be easily positioned in the right unique position, with no additional tissue removal compared to the traditional approach, requiring just removal of the soft tissue under the small contact points using an electric cutter. The surgeon evaluated (and corrected) some wrong stable template positions when not all the contact points were in contact with the bone surface. The post-op evaluation was made with a CT scan that showed 1 cortical pedicle violation (3.5%) (grade II according to the FU classification).

Introduction. Pedicle screw fixation commonly uses a manual probe technique for preparation and insertion of the screw. However, the accuracy of obtaining a centrally located path using the probe is often dependent on the experience of the surgeon and may lead to increased complications. Fluoroscopy and navigation assistance improves accuracy but may expose the patient and surgeon to excessive radiation. DSG measures electrical conductivity at the tip and provides the surgeon with real-time audio and visual feedback based on differences in tissue density between cortical and cancellous bone and soft tissue. The authors investigated the effectiveness of DSG for training residents on safe placement of pedicle screws. Methods. 15 male cadaveric thoracolumbar spine specimens were fresh-frozen at the time of expiration. Residents were assigned 3 specimens each and randomised by pedicle side and order of technique for pedicle screw placement (free-hand versus DSG). Fluoroscopy and other navigation assistance were not used for pedicle preparation. All specimens were imaged using CT following insertion of all pedicle screws. The accuracy was assessed by a senior radiologist and graded as within (≤ 2mm breach) or outside (> 2mm breach) the pedicle. Results. 15 specimens were dissected in standard fashion to expose the thoracolumbar spine (T7-L5). 5 residents were randomised and assigned 3 specimens each to prepare bilateral pedicles from T8 to L5 (60 pedicles per resident) using either PediGuard or free-hand technique. A total of 249 pedicle screws were placed. Post-procedure CT scans demonstrated 214 (85.9%) screws within the pedicle. Breach rate for the DSG group was 8.2% and 19.7% for the non-DSG group, with an overall reduction of 58% (p=0.025). Conclusion. The use of Dynamic Surgical Guidance decreased the pedicle screw placement learning curve in residents, while improving breach rate by 58%. This study demonstrates that DSG has the potential for resident education and refinement in operative technique

To introduce a new robot-assisted surgical system for spinal posterior fixation which called TiRobot, based on intraoperative three-dimensional images. TiRobot has three components: the planning and navigation system, optical tracking system and robotic arm system. By combining navigation and robot techniques, TiRobot can guide the screw trajectories for orthopedic surgeries. In this randomised controlled study approved by the Ethics Committee, 40 patients were involved and all has been fully informed and sign the informed consent. 17 patients were treated by free-hand fluoroscopy-guided surgery, and 23 patients were treated by robot-assisted spinal surgery. A total of 190 pedicle screws were implanted. The overall operation times were not different for both groups. None of the screws necessitated re-surgery for revised placement. In the robot-assisted group, assessment of pedicle screw accuracy showed that 102 of 102 screws (100%) were safely placed (<2 mm, category A+B). And mean deviation in entry point was 1.70 +/− 0.83mm, mean deviation in end point was 1.84 +/− 1.04mm. In the conventional freehand group, assessment of pedicle screw accuracy showed that 87 of 88 (98.9%) were safely placed (<2 mm, category A+B), 1 screw fall in category C, mean deviation in entry point was 3.73 +/− 2.28mm, mean deviation in end point was 4.11 +/− 2.31mm. This randomised controlled study verified that robot-assisted pedicle screw placement with real-time navigation is a more accuracy and safer method, and also revealed great clinical potential of robot-assisted surgery in the future

The objective of this paper is to demonstrate the difference in post-operative complication rates between Computer-assisted surgery (CAS) and conventional techniques in spine surgery. Several studies have shown that the accuracy of pedicle screw placement significantly improves with use of CAS. Yet, few studies have compared the incidence of post-operative complications between CAS and conventional techniques. The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database was used to identify patients that underwent posterior lumbar fusion from 2011 to 2013. Multivariate analysis was conducted to demonstrate the difference in post-operative complication rates between CAS and conventional techniques in spine surgery. Out of 15,222 patients, 14,382 (95.1%) were operated with conventional techniques and 740 (4.90%) were operated with CAS. Multivariate analysis showed that patients in the CAS group had less odds to experience adverse events post-operatively (OR 0.57, P <0.001). This paper examined the complications in lumbar spinal surgery with or without the use of CAS. These results suggest that CAS may provide a safer technique for implant placement in lumbar fusion surgeries

Introduction. The education of residents in the proper placement of pedicle screws is key to the safety of the surgery. The more experienced the surgeon, the more accurately the pedicle screws tend to be placed. A physical bone model, with properties and tactile feel similar to human bone, was developed with the intention of using the bone model to train residents in pedicle screw placement. The purpose of this study was to test whether the model improves the performance of orthopaedic residents when cannulating spinal pedicles, as judged by the number of breaches, and to gain feedback from the residents on their experiences. Materials and Methods. Six orthopaedic residents were recruited, with ethics approval. Prior to testing, the residents were given an instructional video describing the correct cannulation of a lumbar vertebra. The residents were each provided with 12 bones mounted in holders: 3 for initial skills assessment, 6 for free practice, and 3 for final skills assessment. In the pre- and post-practice sets, the 3 bone models had different properties: weak, normal and strong. The residents were asked to complete both pre and post-testing questionnaires. The number of breaches was counted in initial and final bone testing. The forces for each bone model were compared using an ANOVA; these were followed by post-hoc t-tests if significant (p<0.05). Results. All but one of the residents improved the number of breaches with practice, and the one that did not improve did not make the same breaches twice. The total number of breaches in the final testing (14) was lower than in the initial testing (31). The entry points chosen by the residents were all deemed appropriate as per the video instruction. The resident with the most experience had the least number of breaches; the resident with the least amount of experience had the most breaches. Discussion. The reduction of the number of breaches between the initial and final testing indicates that the residents did learn. Overall the response from the residents was positive; they all indicated they would like to have the simulator as part of their training; most even indicated an interest to use them outside of training hours. Almost all indicated that the bones felt more realistic than those currently available (if they were aware of them). Positively, the more surgical experience the resident had, the more their survey responses indicated a positive impression of the bones

Summary. Optimum position of pedicle screws can be determined preoperatively by CT based planning. We conducted a comparative study in order to analyse manually determined pedicle screw plans and those that were obtained automatically by a computer software and found an agreement in plans between both methods, yet an increase in fastening strengths was observed for automatically obtained plans. Hypothesys. Automatic planning of pedicle screw positions and sizing is not inferior to manual planning. Design. Prospective comparative study. Introduction. Preoperative planning in spinal deformity surgery starts by a proper selection of implant anchors throughout the instrumented spine, where pedicle screws provide the optimum choice for bone fixation. In the case of severe spinal deformities, dysplastic pedicles can limit screw usage, and therefore studying the anatomy of vertebrae from preoperative images can aid in achieving the safest screw position through optimal fastening strength. The purpose of this study is to compare manually and automatically obtained preoperative pedicle screw plans. Materials and Methods. CT scans of 17 deformed thoracic spines were studied by two experienced spine deformity surgeons, who placed 316 pedicle screws in 3D using a software positioning tool by aiming for the safest trajectory that permitted the largest possible screw sizes. The resulting manually obtained screw sizes, trajectory angles, entry points and normalised fastening strengths were compared to those obtained automatically by a dedicated computer software that, basing on vertebral anatomy and bone density in 3D, determined optimal screw sizes and trajectories. Results. Statistically significant differences were observed between manually and automatically obtained plans for screw sizes (p < 0.05) and trajectory angles (p < 0.001). However, for automatically obtained plans, screws were not smaller in diameter (p < 0.05) or shorter in length (p < 0.001), while screw normalised fastening strengths were higher (p < 0.001). Conclusions. In comparison to manual planning, automatically obtained plans did not result in smaller screw diameters or shorter screw lengths, which is in agreement with the definition of the pull-out strength, but in different screw trajectory angles, which is reflected by higher normalised fastening strengths. Captions. Fig. 1. Visual comparison among automatically obtained (green colour) and manually defined pedicle screw placement plans by two experienced spine surgeons (red and blue colour) for three different patients with adolescent idiopathic scoliosis, shown from top to bottom in a three-dimensional view, left sagittal, right sagittal and coronal view. Fig. 2. Histograms of differences between observers and (left column), between observer and automated method (middle column), and between observer and automated method (right column), shown from top to bottom for differences in pedicle screw pedicle screw diameter, sagittal inclination, and normalised fastening strength. For figures/tables, please contact authors directly.

While image guidance and neuro-navigation have enabled a more accurate positioning of pedicle implants, robot-assisted placement of pedicle screws appears to overcome the disadvantages of the two first systems. However, recent data concerning the superiority of robots currently available to assist spinal surgeons in the accurate positioning of implants are conflicting. The aim of our study was to evaluate the percentage of accurate positioning of pedicle screws inserted using a new robotic-guidance system. Patients were operated on successively by the same surgeon using robotic-assistance (RA; n=40) or by the freehand conventional technique (FH; n=54). Ten and eleven patients from the robot (RG) and freehand (FHG) groups respectively, age-matched and all suffering from degenerative lumbar spine disease were compared. Patient characteristics as well as the duration of the operation and of exposure to X-rays were recorded. The Gertzbein Robbins classification was used to evaluate implant placement. Data wer compared between the groups. Pedicle screw placement in RG patients was achieved using the ROSA™ (Medtech) robot comprising a compact robotic arm on a floor-fixable mobile base. By permanently monitoring the patient's movements, this image-guided tool helps more accurately to pinpoint the pedicle entry point and to control the trajectory. The mean age of patients in each group (RG and FHG) was 63 years. Mean BMI and operating time among the RG and FHG were respectively 26 and 27 kg/m. 2. , and 187 and 119 min. Accurate placement of the implant (score A-B) was achieved in 97.2% of patients in the RG (n=36) and in 92.6% of those in the FHG (n=54). Four implants in the RG were placed manually following failed robotic assistance. The mean duration of X-ray exposure per patient was 1 min 42s in the RG and 41s in the FHG. We report a higher rate of accuracy with robotic assistance as compared to the FH technique. Exposure time was greater in the RG partly due to the fluoroscopic control of the implants required for this pilot study of feasibility. Limitations of the study include its small sized and non-randomised sample. Nevertheless, these preliminary results are encouraging for the development of new robotic techniques for spinal surgery