Accuracy Of Pedicle Screw Insertion Research Articles

Fully automated determination of robotic pedicle screw accuracy and precision utilizing computer vision algorithms

Historically, pedicle screw accuracy measurements have relied on CT and expert visual assessment of the position of pedicle screws relative to preoperative plans. Proper pedicle screw placement is necessary to avoid complications, cost and morbidity of revision procedures. The aim of this study was to determine accuracy and precision of pedicle screw insertion via a novel computer vision algorithm using preoperative and postoperative computed tomography (CT) scans. Three cadaveric specimens were utilized. Screw placement planning on preoperative CT was performed according to standard clinical practice. Two experienced surgeons performed bilateral T2–L4 instrumentation using robotic-assisted navigation. Postoperative CT scans of the instrumented levels were obtained. Automated segmentation and computer vision techniques were employed to align each preoperative vertebra with its postoperative counterpart and then compare screw positions along all three axes. Registration accuracy was assessed by preoperatively embedding spherical markers (tantalum beads) to measure discrepancies in landmark alignment. Eighty-eight pedicle screws were placed in 3 cadavers’ spines. Automated registrations between pre- and postoperative CT achieved sub-voxel accuracy. For the screw tip and tail, the mean three-dimensional errors were 1.67 mm and 1.78 mm, respectively. Mean angular deviation of screw axes from plan was 1.58°. For screw mid-pedicular accuracy, mean absolute error in the medial–lateral and superior–inferior directions were 0.75 mm and 0.60 mm, respectively. This study introduces automated algorithms for determining accuracy and precision of planned pedicle screws. Our accuracy outcomes are comparable or superior to recent robotic-assisted in vivo and cadaver studies. This computerized workflow establishes a standardized protocol for assessing pedicle screw placement accuracy and precision and provides detailed 3D translational and angular accuracy and precision for baseline comparison.

Surgical outcomes of robotic-assisted percutaneous fixation for thoracolumbar fractures in patients with ankylosing spondylitis

BackgroundSpinal fractures in patients with ankylosing spondylitis (AS) mainly present as instability, involving all three columns of the spine, and surgical intervention is often considered necessary. However, in AS patients, the significant alterations in bony structure and anatomy result in a lack of identifiable landmarks, which increases the difficulty of pedicle screw implantation. Therefore, we present the clinical outcomes of robotic-assisted percutaneous fixation for thoracolumbar fractures in patients with AS.MethodsA retrospective review was conducted on a series of 12 patients diagnosed with AS. All patients sustained thoracolumbar fractures between October 2018 and October 2022 and underwent posterior robotic-assisted percutaneous fixation procedures. Outcomes of interest included operative time, intra-operative blood loss, complications, duration of hospital stay and fracture union. The clinical outcomes were assessed using the visual analogue scale (VAS) and Oswestry Disability Index (ODI). To investigate the achieved operative correction, pre- and postoperative radiographs in the lateral plane were analyzed by measuring the Cobb angle.ResultsThe 12 patients had a mean age of 62.8 ± 13.0 years and a mean follow-up duration of 32.7 ± 18.9 months. Mean hospital stay duration was 15 ± 8.0 days. The mean operative time was 119.6 ± 32.2 min, and the median blood loss was 50 (50, 250) ml. The VAS value improved from 6.8 ± 0.9 preoperatively to 1.3 ± 1.0 at the final follow-up (P < 0.05). The ODI value improved from 83.6 ± 6.1% preoperatively to 11.8 ± 6.6% at the latest follow-up (P < 0.05). The average Cobb angle changed from 15.2 ± 11.0 pre-operatively to 8.3 ± 7.1 at final follow-up (P < 0.05). Bone healing was consistently achieved, with an average healing time of 6 (5.3, 7.0) months. Of the 108 screws implanted, 2 (1.9%) were improperly positioned. One patient experienced delayed nerve injury after the operation, but the nerve function returned to normal upon discharge.ConclusionPosterior robotic-assisted percutaneous internal fixation can be used as an ideal surgical treatment for thoracolumbar fractures in AS patients. However, while robot-assisted pedicle screw placement can enhance the accuracy of pedicle screw insertion, it should not be relied upon solely.

A Novel Intraoperative CT Navigation System for Spinal Fusion Surgery in Lumbar Degenerative Disease: Accuracy and Safety of Pedicle Screw Placement.

Background: In recent years, intraoperative computed tomography (CT) navigation has become widely used for the insertion of pedicle screws in spinal fusion surgery. However, conventional intraoperative CT navigation may be impaired by infrared interference between the infrared camera and surgical instruments, which can lead to the misplacement of pedicle screws. Recently, a novel intraoperative CT navigation system, NextAR, has been developed. It uses a small infrared camera mounted on surgical instruments within the surgical field. NextAR navigation can minimize the problem of infrared interference and be expected to improve the accuracy of pedicle screw placement. Methods: This study investigated the accuracy of pedicle screw insertion under NextAR navigation in spinal fusion surgery for lumbar degenerative diseases. The accuracy of pedicle screw placement was evaluated in 15 consecutive patients using a CT grading scale. Results: Screw perforation occurred in only 1 of the total 70 screws (1.4%). Specifically, there was one grade 1 perforation within 2 mm, but no perforations larger than 2 mm. There were no reoperations or neurological complications due to screw misplacement. Conclusions: NextAR navigation can provide high accuracy for pedicle screw insertion and help ensure safe spinal fusion surgery for lumbar degenerative diseases.

The accuracy and feasibility study of freehand pedicle screw insertion for subaxial cervical spine assisted with safe core-referred technique

Objectives: To construct the "safe core" of the pedicle screw trajectory using CT imaging data of the subaxial cervical spine in adults, and to assess the accuracy and feasibility of the pedicle screw insertion assisted with the "safe core-referred technique" for subaxial cervical spine with a cadaver specimen study. Methods: This is an experimental study. From January 2015 to March 2020,60 adults' CT images data of the cervical spine were collected from the database of the First Affiliated Hospital of Gannan Medical University,and were imported into Mimics 20.0 software. Virtual cervical pedicle trajectory and safe core were constructed according to the self-designed "virtual construction method of pedicle in the subaxial cervical spine". The success rate of the construction and the spatial position data of the virtual safe core of was recorded,including the distance between the safe core and the tangent line of the upper and lower outer edge of Luschka's joint on coronal plane,and the distance between the safe core and the posterior edge of the vertebral body on sagittal plane.The 3.5 mm column was used to simulate the pedicle screw placement,using the safe core as the only hub in pedicle screw trajectory.The length of the anterior pedicle screw trajectory,the interval of the abductive angle of the pedicle screw in axial plane, and the projection area of the entry area on periapical radiograph was calculated.In addition,8 adult cervical cadaver specimens were collected for the pedicle screw insertion experiment.The left side group used the "safe core-referred technique" for pedicle screw insertion,while the right side group used the Abumi method for pedicle screw insertion.The accuracy of pedicle screw placement was verified by CT scan.The difference between the accuracy of subjective judgment based on X-ray monitoring of operator and the actual accuracy of pedicle screw insertion verified by CT scan was compared between the two groups.The chi-square test was used to compare the intergroup data. Results: The total success rate of the virtual construction method for the safe core of the subaxial cervical spine was 97.0% (291/300); The distance between the safe core and the tangent line of the upper and lower outer edge of Luschka's joint on coronal plane was (M(IQR)) 0.91 (0.98) mm (range: 0 to 1.85 mm);The distance between the safe core and the posterior wall on the sagittal plane of the vertebral body was (2.01±0.86) mm (range: 0.67 to 3.53 mm). The distance (anterior pedicle screw trajectory) from the posterior cortex to the central point of the safe core was (11.58±1.00)mm (range: 8.27 to 14.93 mm).The projection area of the entry point on the coronal plane was (36.18±11.67) mm2 (range: 13.38 to 83.11 mm2). Pedicle screw insertion experiment in cervical cadaver specimen showed the rate of intraoperative correction of the pedicle screw trajectory was 7.5% (3/40) in the experimental group and 12.5% (5/40) in the control group (χ2=0.139,P=0.709). The operator 's correct rate of subjective judgment on CT in the stage of pedicle screw trajectory preparation was 100% (40/40) in the experimental group and 82.5% (33/40) in the control group, the difference was statistically significant (χ2=5.638,P=0.018). The actual correct rate of CT verification in the stage of pedicle screw insertion was 100% (40/40) in the experimental group and 90.0% (36/40) in the control group, the difference was statistically significant (χ2=2.368,P=0.124); The operator 's correct rate of subjective judgment in the stage of pedicle screw insertion completion was 100% (83/83) in the experimental group and 92.9% (79/85) in the control group (χ2=4.199,P=0.040). Conclusions: The virtual safe-core of subaxial cervical spine can be use as a reliable anatomical fluoroscopy landmark for freehand pedicle screw insertion."Safe core-referred technique" can improve the accuracy rate of the operator's subjective judgment on the intraoperative fluoroscopy monitoring,and hence improve the accuracy of freehand pedicle screw insertion technology for subaxial cervical spine. And it still needs to be further verified in clinical practice.

Pedicle screw accuracy placed with assistance of machine vision technology in patients with neuromuscular scoliosis.

Pedicle screws are the primary method of vertebral fixation in scoliosis surgery, but there are lingering concerns over potential malposition. The rates of pedicle screw malposition in pediatric spine surgery vary from 10% to 21%. Malpositioned screws can lead to potentially catastrophic neurological, vascular, and visceral complications. Pedicle screw positioning in patients with neuromuscular scoliosis is challenging due to a combination of large curves, complex pelvic anatomy, and osteopenia. This study aimed to determine the rate of pedicle screw malposition, associated complications, and subsequent revision from screws placed with the assistance of machine vision navigation technology in patients with neuromuscular scoliosis undergoing posterior instrumentation and fusion. A retrospective analysis of the records of patients with neuromuscular scoliosis who underwent thoracolumbar pedicle screw insertion with the assistance of machine-vision image guidance navigation was performed. Screws were inserted by either a staff surgeon, orthopaedic fellow, or orthopaedic resident. Post-operative ultra-low dose CT scans were used to assess pedicle screw accuracy. The Gertzbein classification was used to grade any pedicle breaches (grade 0, no breach; grade 1, <2 mm; grade 2, 2-4 mm; grade 3, >4 mm). A screw was deemed accurate if no breach was identified (grade 0). 25 patients were included in the analysis, with a mean age of 13.6 years (range 11 to 18 years; 13/25 (52.0%) were female. The average pre-operative supine Cobb angle was 90.0 degrees (48-120 degrees). A total of 687 screws from 25 patients were analyzed (402 thoracic, 241 lumbosacral, 44 S2 alar-iliac (S2AI) screws). Surgical trainees (fellows and orthopaedic residents) inserted 46.6% (320/687) of screws with 98.8% (4/320) accuracy. The overall accuracy of pedicle screw insertion was 98.0% (Grade 0, no breach). All 13 breaches that occurred in the thoracic and lumbar screws were Grade 1. Of the 44 S2AI screws placed, one screw had a Grade 3 breach (2.3%) noted on intra-operative radiographs following rod placement and correction. This screw was subsequently revised. None of the breaches resulted in neuromonitoring changes, vessel, or visceral injuries. Machine vision navigation technology combined with careful free-hand pedicle screw insertion techniques demonstrated high levels of pedicle screw insertion accuracy, even in patients with challenging anatomy.

Clinical Outcome Analysis of Robot-Assisted Pedicle Screw Insertion in the Treatment of Ankylosing Spondylitis Complicated with Spinal Fractures

BackgroundVague spinal anatomical landmarks in patients with ankylosing spondylitis (AS) make intraoperative insertion of pedicle screws difficult under direct vision. Currently, the clinical outcome is significantly improved with robot guidance. This study aims to explore the efficacy of robot-assisted pedicle screw insertion in treating AS combined with spinal fractures. Methods40 patients (341 screws) who underwent pedicle screw insertion with AS complicated with spinal fractures were included. According to different surgical methods, 16 patients (135 screws) were classified into the robot group and 24 (206 screws) into the free-hand group. Intraoperative blood loss, operative duration, and adverse events were compared between the two groups. Gertzbein and Robbins classification was used to classify the accuracy of screw position. Clinical outcomes were evaluated by Visual Analog Scale, Japanese Orthopedic Association, and Oswestry Disability Index. ResultsNo statistically significant differences between baseline data of the groups. The difference in the blood loss between groups wasn’t significant, nor was the operative duration. No severe adverse events related to pedicle screw insertion were reported in either group. Notably, the accuracy of screw insertion was significantly higher in the robot group (129/135) than in the free-hand group (182/206). The lateral perforation prevalence didn’t differ among groups. VAS in the third month postoperatively was lower in the robot group than in the free-hand group, with a significant difference. ConclusionsThe study demonstrates statistically superior accuracy and surgical outcome of robot-assisted pedicle screw insertion in the treatment of AS complicated with spinal fractures compared with the traditional free-hand operation.

EVALUATION OF CLINICAL OUTCOMES AND ACCURACY IN TRANSPEDICULAR SCREW FIXATION USING INTRAOPERATIVE CT-GUIDED NAVIGATION FOR LUMBAR SPONDYLOLISTHESIS

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&lt;.01). ODI decreased from 35.4%±15 to 11.8%±14 (p&lt;.01). An increase of SF-36 from 51.5±14 to 76±13 (p&lt;.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.

CT-navigated C2 Pedicle Screw insertion using dynamic reference array on C2 spinous process: A Novel Technique

ntroduction: Spine surgeons have endeavoured to improve the accuracy of pedicle screw insertion. Computed tomography (CT) guided navigation has been helpful in precisely passing pedicle screws even further accurately but, there were shortcomings noted with the technique due to movement between reference frame and anatomical landmarks, especially in the cervical spine which led to injury of vital neurovascular structures. Thus, there was a need for developing a technique which would eliminate the inherent error due to movement in the vertebral body while passing screws. Research Question: Can using C2 spinous process as an attachment for the reference array improve accuracy of C2 pedicle screws. Material and Methods: We prospectively studied data of 10 patients (20 screws) in whom Computed tomography navigated C2 pedicle screws insertion was carried out using the reference array on C2 spinous process. Accuracy of pedicle screws were confirmed by post instrumentation Computed tomography scan immediately intra operatively. Results: With the presented technique overall breach rate was 5% with one screw having a medial breach of grade 1 with no incidence of neurovascular injury or need for further revision. Discussion and Conclusion: Results from this study shows better accuracy than other techniques described to pass C2 pedicle screws eliminating the error in movement from the cervical vertebrae and the reference frame being nearest to the C2 pedicle. Although there is a learning curve with the adoption of the navigation system, with experience, the challenges associated with Cervical pedicle screws (CPS) insertion can be overcome.

Three-Dimensional Quantitative Assessment of Pedicle Screw Accuracy in Clinical Utilization of a New Robotic System in Spine Surgery: A Multicenter Study.

The objective of this study was to evaluate the accuracy of pedicle screw placement in patients undergoing percutaneous pedicle screw fixation with robotic guidance, using a newly developed 3-dimensional quantitative measurement system. The study also aimed to assess the clinical feasibility of the robotic system in the field of spinal surgery. A total of 113 patients underwent pedicle screw insertion using the CUVIS-spine pedicle screw guide system (CUREXO Inc.). Intraoperative O-arm images were obtained, and screw insertion pathways were planned accordingly. Image registration was performed using paired-point registration and iterative closest point methods. The accuracy of the robotic-guided pedicle screw insertion was assessed using 3-dimensional offset calculation and the Gertzbein-Robbins system (GRS). A total of 448 screws were inserted in the 113 patients. The image registration success rate was 95.16%. The average error of entry offset was 2.86 mm, target offset was 2.48 mm, depth offset was 1.99 mm, and angular offset was 3.07°. According to the GRS grading system, 88.39% of the screws were classified as grade A, 9.60% as grade B, 1.56% as grade C, 0.22% as grade D, and 0.22% as grade E. Clinically acceptable screws (GRS grade A or B) accounted for 97.54% of the total, with no reported neurologic complications. Our study demonstrated that pedicle screw insertion using the novel robot-assisted navigation method is both accurate and safe. Further prospective studies are necessary to explore the potential benefits of this robot-assisted technique in comparison to conventional approaches.

Robotics and navigation in spine surgery: A narrative review

IntroductionIn recent decades, there has been a rising trend of spinal surgical interventional techniques, especially Minimally Invasive Spine Surgery (MIS), to improve the quality of life in an effective and safe manner. However, MIS techniques tend to be difficult to adapt and are associated with an increased risk of radiation exposure. This led to the development of ‘computer-assisted surgery’ in 1983, which integrated CT images into spinal procedures evolving into the present day robotic-assisted spine surgery. The authors aim to review the development of spine surgeries and provide an overview of the benefits offered. It includes all the comparative studies available to date. MethodsThe manuscript has been prepared as per “SANRA-a scale for the quality assessment of narrative review articles”. The authors searched Pubmed, Embase, and Scopus using the terms “(((((Robotics) OR (Navigation)) OR (computer assisted)) OR (3D navigation)) OR (Freehand)) OR (O-Arm)) AND (spine surgery)” and 68 articles were included for analysis excluding review articles, meta-analyses, or systematic literature. ResultsThe authors noted that 49 out of 68 studies showed increased precision of pedicle screw insertion, 10 out of 19 studies show decreased radiation exposure, 13 studies noted decreased operative time, 4 out of 8 studies showed reduced hospital stay and significant reduction in rates of infections, neurological deficits, the need for revision surgeries, and rates of radiological ASD, with computer-assisted techniques. ConclusionComputer-assisted surgeries have better accuracy of pedicle screw insertion, decreased blood loss and operative time, reduced radiation exposure, improved functional outcomes, and lesser complications.

Comparative Study on Accuracy of Intra-Operative Computed Tomography-Navigation Based Pedicle Screw Placement With Skin vs Bone Fixed Dynamic Reference Frame in Minimally Invasive Transforaminal Lumbar Interbody Fusion.

Retrospective comparative study. To compare the accuracy of intra-operative navigation-assisted percutaneous pedicle screw insertion between bone fixed and skin fixed dynamic reference frame (DRF) in Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Between October 2018 and September 2022, patients who underwent MIS-TLIF were included in this study with DRF fixed either on bone (group B) or skin (group S). Pedicle screws were inserted under the guidance of intra-operative Cone bean Computed tomography (cbCT) based navigation. Accuracy of pedicle screw placement was immediately checked by a final intra-operative cbCT Spin. Among 170 patients, group B included 91 patients and group S included 79 patients. Out of total 680 screws, 364 screws (group B) and 316 screws (group S) were placed. Patient's demographic data and distribution of screws showed no statistically significant difference. The accuracy showed no significant difference between both the groups (94.5% in group B and 94.3% in group S). Skin fixed DRF can serve as an alternate way for placement and avoids extra incision with similar accuracy in pedicle screw insertions with bone fixed DRF using intra-operative CT guided navigation in MIS TLIF.

Analysis of accuracy of pedicle screw placement in dysplastic pedicles in adolescent idiopathic scoliosis using the pedicle expansion technique with CT-based navigation

BackgroundThis study aimed to study the accuracy of pedicle screw (PS) insertion into dysplastic pedicles in adolescent idiopathic scoliosis (AIS) comparing cannulated screw using the pedicle expansion technique (PET) versus conventional technique. MethodsForty-two AIS patients with 766 PSs were evaluated. In total, 236 screws were inserted into dysplastic pedicles: 138 and 98 screws were inserted using the PET (PET group) and standard technique (conventional group), respectively. Both methods used CT-based navigation to determine the insertion point. In the PET, a rigid ball tip feeler was tapped with a mallet to create an insertion route, a guide wire was passed through the tap, the pedicle was enlarged, and then a cannulated PS with a diameter of 4.35 mm was inserted. Postoperative CT was used to compare the accuracy of PS insertion. ResultsIn total, 23/236 (9.7%) perforations occurred. Regarding overall perforation, there were six (4.3%) and 17 (17.3%) cases in the PET and conventional group, respectively (P = 0.008). In terms of medial perforation, the PET group (n = 2, 1.4%) was significantly better than the conventional group (n = 7, 7.1%) (P = 0.021). In terms of lateral perforation, the PET group (n = 4, 2.9%) was significantly better than conventional group (n = 10, 10.2%) (P = 0.030). Only grade 1 perforation had occurred in the PET group, whereas grades 2 and 3 perforation occurred in the conventional group. ConclusionUse of the PET with CT-based navigation significantly increased the accuracy and safety of PS insertion in dysplastic pedicles in AIS.

Do 3D printed templates aid in exposure, improve the accuracy and safety of pedicle screw insertion in complex spinal kypho-scoliotic deformities? A comparative cohort study

Do 3D printed templates aid in exposure, improve the accuracy and safety of pedicle screw insertion in complex spinal kypho-scoliotic deformities? A comparative cohort study

Development and Clinical Trial of a New Orthopedic Surgical Robot for Positioning and Navigation.

Robot-assisted orthopedic surgery has great application prospects, and the accuracy of the robot is the key to its overall performance. The aim of this study was to develop a new orthopedic surgical robot to assist in spinal surgeries and to compare its feasibility and accuracy with the existing orthopedic robot. A new type of high-precision orthopedic surgical robot (Tuoshou) was developed. A multicenter, randomized controlled trial was carried out to compare the Tuoshou with the TiRobot (TINAVI Medical Technologies Co., Ltd., Beijing) to evaluate the accuracy and safety of their navigation and positioning. A total of 112 patients were randomized, and 108 patients completed the study. The position deviation of the Kirschner wire placement in the Tuoshou group was smaller than that in the TiRobot group (p = 0.014). The Tuoshou group was better than the TiRobot group in terms of the pedicle screw insertion accuracy (p = 0.016) and entry point deviation (p < 0.001). No differences were observed in endpoint deviation (p = 0.170), axial deviation (p = 0.170), sagittal deviation (p = 0.324), and spatial deviation (p = 0.299). There was no difference in security indicators. The new orthopedic surgical robot was highly accurate and optimized for clinical practice, making it suitable for clinical application.

Patient-Specific Drill Guide Template for Pedicle Screw Insertion into the Atlantoaxial Cervical Spine Using Stereolithographic Modeling: An In Vitro Study.

Cadaveric study. This study aimed to assess the accuracy and feasibility of cervical pedicle screw (CPS) insertion into the atlantoaxial cervical spine using a patient-specific drill guide template constructed from a stereolithographic model. CPS fixation is a widely accepted procedure for posterior cervical fixation because of its biomechanical advantages, particularly in the subaxial cervical region. The extremely narrow corridors of the atlantoaxial spine make CPS insertion more difficult, requiring the development of new tools to ensure accurate placement. Fifteen atlantoaxial cervical vertebra specimens from 15 cadavers were scanned into thin slices using computed tomography. Images of the cadaver spine were digitally processed and rendered stl files so that they could be printed to scale as threedimensional (3D) plastic models. Manually molded dental acrylic drill guide templates with pins inserted in the pedicles of the plastic cervical models were placed over the 3D printed models. The drill guide templates were used for precise placement of the drill holes in the pedicles of cadaveric specimens for pedicle screw fixation. The accuracy of screw placement was evaluated by an independent evaluator. A total of 60 pedicles (combined C1 and C2) from 15 cadaveric axial cervical vertebrae were evaluated. The total acceptable accuracy for pedicle screw insertion in the atlantoaxial cervical vertebrae is 95%. An accuracy rate of 100% was achieved for C1 while an acceptable accuracy rate of 90% was achieved for C2. The use of a patient-specific drill guide constructed using stereolithography improved the accuracy of CPS placement in a cadaveric model.

Novel C-arm-based planning robotic spinal surgery in a cadaver model using quantitative accuracy assessment methodology.

This preclinical study emulating the clinical environment quantitatively analysed the accuracy of pedicle screw insertion using a navigated robotic system. Pedicle screws were placed from T7 to L5 in the whole-body form of a cadaver. After the insertion of multiple artificial markers into each vertebra, errors between the planned insertion path and the inserted screw were quantified using the Gertzbein-Robbins system (GRS) and offset calculation. A total of 22 screws were placed. Almost all (95.45% [21/22]) were classified as GRS A or B, while one (4.55%) was GRS C. The mean and standard deviations of entry, tip, and angular offset were 1.78±0.94mm, 2.30±1.01mm, and 2.64±1.05°, respectively. This study demonstrated that pedicle screw insertion using a navigated robotic system had high accuracy and safety. A future clinical study is necessary to validate our findings.

Does three-dimensional preoperative planning improve accuracy of pedicle screw insertion?

Does three-dimensional preoperative planning improve accuracy of pedicle screw insertion?

Accuracy and safety of percutaneous pedicle screw placement using the K-wireless minimally invasive spine percutaneous pedicle screw system in Japan: A randomized active controlled study

BackgroundMinimally invasive lumbar fusion has recently become a widely used technique worldwide. This randomized active controlled study was conducted to demonstrate the non-inferiority of the K-wireless Minimally Invasive Spine (MIS) Percutaneous Pedicle Screw (PPS) system compared with use of the six pedicle screw systems currently used in our practices with respect to the accuracy of pedicle screw placement.Also to compare the screw-insertion time and number of fluoroscopic observations during screw insertion between the groups. MethodsA total of 80 patients with degenerative spinal diseases or vertebral fractures were assigned, including 41 patients in the K-wireless MIS PPS system group (K-wireless group) and 39 in the control group (K-wire group).The accuracy of the screw insertion, screw-insertion time, number of fluoroscopic observations during screw insertion, and the incidence of adverse events were compared between the K-wireless group and the K-wire group. The accuracy rate was calculated as the number of screws with no breach divided by the total number of screws. ResultsThe accuracy rates of screw insertion were 85.7% and 75.0% in the K-wireless and K-wire groups, respectively, with an intergroup difference of 10.7% (95% confidence interval: 2.3–19.1%). The K-wireless group demonstrated non-inferiority compared with the K-wire group. The mean screw-insertion time was significantly shorter in the K-wireless group (2.62 and 2.97 min in the K-wireless and K-wire groups, respectively; P=0.005). There were also significantly fewer fluoroscopies in the K-wireless group (10.7 and 17.4 in the K-wireless and K-wire groups, respectively; P<0.001). There were no device-related or study treatment-related adverse events in either group. ConclusionsThe accuracy of pedicle screw insertion using the K-wireless MIS PPS system was not inferior to that of existing products. In terms of safety, no product-related or treatment-related adverse events were identified in this study and no new safety concerns were noted.

Ultrasound-based navigated pedicle screw insertion without intraoperative radiation: feasibility study on porcine cadavers

BACKGROUNDNavigation systems for spinal fusion surgery rely on intraoperative computed tomography (CT) or fluoroscopy imaging. Both expose patient, surgeons and operating room staff to significant amounts of radiation. Alternative methods involving intraoperative ultrasound (iUS) imaging have recently shown promise for image-to-patient registration. Yet, the feasibility and safety of iUS navigation in spinal fusion have not been demonstrated. PURPOSETo evaluate the accuracy of pedicle screw insertion in lumbar and thoracolumbar spinal fusion using a fully automated iUS navigation system. STUDY DESIGNProspective porcine cadaver study. METHODSFive porcine cadavers were used to instrument the lumbar and thoracolumbar spine using posterior open surgery. During the procedure, iUS images were acquired and used to establish automatic registration between the anatomy and preoperative CT images. Navigation was performed with the preoperative CT using tracked instruments. The accuracy of the system was measured as the distance of manually collected points to the preoperative CT vertebral surface and compared against fiducial-based registration. A postoperative CT was acquired, and screw placements were manually verified. We report breach rates, as well as axial and sagittal screw deviations. RESULTSA total of 56 screws were inserted (5.50 mm diameter n=50, and 6.50 mm diameter n=6). Fifty-two screws were inserted safely without breach. Four screws (7.14%) presented a medial breach with an average deviation of 1.35±0.37 mm (all <2 mm). Two breaches were caused by 6.50 mm diameter screws, and two by 5.50 mm screws. For vertebrae instrumented with 5.50 mm screws, the average axial diameter of the pedicle was 9.29 mm leaving a 1.89 mm margin in the left and right pedicle. For vertebrae instrumented with 6.50 mm screws, the average axial diameter of the pedicle was 8.99 mm leaving a 1.24 mm error margin in the left and right pedicle. The average distance to the vertebral surface was 0.96 mm using iUS registration and 0.97 mm using fiducial-based registration. CONCLUSIONSWe successfully implanted all pedicle screws in the thoracolumbar spine using the ultrasound-based navigation system. All breaches recorded were minor (<2 mm) and the breach rate (7.14%) was comparable to existing literature. More investigation is needed to evaluate consistency, reproducibility, and performance in surgical context. CLINICAL SIGNIFICANCEIntraoperative US-based navigation is feasible and practical for pedicle screw insertion in a porcine model. It might be used as a low-cost and radiation-free alternative to intraoperative CT and fluoroscopy in the future.

Characteristics of pedicle screw misplacement using freehand technique in degenerative scoliosis surgery.

This study aimed to estimate the accuracy of pedicle screw (PS) placement in degenerative scoliosis surgery, characterize a patient population with PS misplacement, and analyze the association between misplaced PS vector and lumbar coronal curve. In this study, 122 patients (average age 68.6years), who underwent corrective and decompression surgery, were selected retrospectively. PS accuracy was evaluated in the thoracic to lumbar spine. We identified characteristics of misplacement in each patient. Screw positions were categorized into grade A, entirely in the pedicle; grade B, < 2mm breach; grade C, 2-4mm breach; and grade D, > 4mm breach using postoperative computed tomography. The mean preoperative lumbar coronal curve was 32.3 ± 18.4°, and the number of fused vertebrae was 8.9 ± 2.8. A total of 2032 PS were categorized as follows: grade A, 1897 PS (93.3%); grade B, 67 (3.3%); grade C, 26 (1.3%); and grade D, 43 (2.1%). One PS (grade D), inserted at T5, needed surgery for removal due to neurological deficit. The misplacement group (grades C and D) had a significantly stronger lumbar coronal curve and apical vertebral rotation than the accuracy group (grades A and B). Misplaced PS vector (direction and degree) was significantly correlated with inserted vertebral rotation. Grade D misplacement was distributed mainly around the transitional vertebra of the lumbar curve. The accuracy of PS insertion in the thoracic to lumbar spine was high in DS surgery, but the need for care was highlighted in the transitional vertebra.