Clinical application of spinal robot in cervical spine surgery: safety and accuracy of posterior pedicle screw placement in comparison with conventional freehand methods.

The novel robot-assisted (RA) technique has been utilized increasingly to improve the accuracy of cervical pedicle screw placement. Although the clinical application of the RA technique has been investigated in several case series and comparative studies, the superiority and safety of RA over conventional freehand (FH) methods remain controversial. Meanwhile, the intra-pedicular accuracy of the two methods has not been compared for patients with cervical traumatic conditions. This study aimed to compare the rate and risk factors of intra-pedicular accuracy of RA versus the conventional FH approach for posterior pedicle screw placement in cervical traumatic diseases. A total of 52 patients with cervical traumatic diseases who received cervical screw placement using RA (26 patients) and FH (26 patients) techniques were retrospectively included. The primary outcome was the intra-pedicular accuracy of cervical pedicle screw placement according to the Gertzbin-Robbins scale. Secondary outcome parameters included surgical time, intraoperative blood loss, postoperative drainage, postoperative hospital stay, and complications. Moreover, the risk factors that possibly affected intra-pedicular accuracy were assessed using univariate analyses. Out of 52 screws inserted using the RA method, 43 screws (82.7%) were classified as grade A, with the remaining 7 (13.5%) and 2 (3.8%) screws classified as grades B and C. In the FH cohort, 60.8% of the 79 screws were graded A, with the remaining screws graded B (21, 26.6%), C (8, 10.1%), and D (2, 2.5%). The RA technique showed a significantly higher rate of optimal intra-pedicular accuracy than the FH method (P = 0.008), but there was no significant difference between the two groups in terms of clinically acceptable accuracy (P = 0.161). Besides, the RA technique showed remarkably longer surgery time, less postoperative drainage, shorter postoperative hospital stay, and equivalent intraoperative blood loss and complications than the FH technique. Furthermore, the univariate analyses showed that severe obliquity of the lateral atlantoaxial joint in the coronal plane (P = 0.003) and shorter width of the lateral mass at the inferior margin of the posterior arch (P = 0.014) were risk factors related to the inaccuracy of C1 screw placement. The diagnosis of HRVA (P < 0.001), severe obliquity of the lateral atlantoaxial joint in the coronal plane (P < 0.001), short pedicle width (P < 0.001), and short pedicle height (P < 0.001) were risk factors related to the inaccuracy of C2 screw placement. RA cervical pedicle screw placement was associated with a higher rate of optimal intra-pedicular accuracy to the FH technique for patients with cervical traumatic conditions. The severe obliquity of the lateral atlantoaxial joint in the coronal plane independently contributed to high rates of the inaccuracy of C1 and C2 screw placements. RA pedicle screw placement is safe and useful for cervical traumatic surgery.

Comparison of major spine navigation platforms based on key performance metrics: a meta-analysis of 16,040 screws.

PURPOSE: The objective of this meta-analysis is to compare available computer-assisted navigation platforms by key performance metrics including pedicle screw placement accuracy, operative time, neurological complications, and blood loss. METHODS: A systematic review was conducted using major databases for articles comparing pedicle screw accuracy of computer-assisted navigation to conventional (freehand or fluoroscopy) controls via post-operative computed tomography. Outcome data were extracted and pooled by random-effects model for analysis. RESULTS: All navigation platforms demonstrated significant reduction in risk of breach, with Stryker demonstrating the highest accuracy compared to controls (OR 0.16 95% CI 0.06 to 0.41, P < 0.00001, I2 = 0%) followed by Medtronic. There were no significant differences in accuracy or most surgical outcome measures between platforms; however, BrainLab demonstrated significantly faster operative time compared to Medtronic by 30 min (95% CI - 63.27 to - 2.47, P = 0.03, I2 = 74%). Together, there was significantly lower risk of major breach in the navigation group compared to controls (OR 0.42, 95% CI 0.27-0.63, P < 0.0001, I2 = 56%). CONCLUSIONS: When comparing between platforms, Stryker demonstrated the highest accuracy, and Brainlab the shortest operative time, both followed by Medtronic. No significant difference was found between platforms regarding neurologic complications or blood loss. Overall, our results demonstrated a 60% reduction in risk of major breach utilizing computer-assisted navigation, coinciding with previous studies, and supporting its validity. This study is the first to directly compare available navigation platforms offering insight for further investigation and aiding in the institutional procurement of platforms. LEVEL 3 EVIDENCE: Meta-analysis of Level 3 studies.

Effects of tracer position on screw placement technique in robot-assisted posterior spine surgery: a case-control study.

INTRODUCTION: Robot-assisted spine surgery is increasingly used in clinical work, and the installation of tracers as a key step in robotic surgery has rarely been studied. OBJECTIVE: To explore the potential effects of tracers on surgical outcomes in robot-assisted posterior spine surgery. METHODS: We reviewed all patients who underwent robotic-assisted posterior spine surgery at Beijing Shijitan Hospital over a 2-year period from September 2020 to September 2022. Patients were divided into two groups based on the location of the tracer (iliac spine or vertebral spinous process) during robotic surgery and a case-control study was conducted to determine the potential impact of tracer location on the surgical procedure. Data analysis was performed using SPSS.25 statistical software (SPSS Inc., Chicago, Illinois). RESULTS: A total of 525 pedicle screws placed in 92 robot-assisted surgeries were analyzed. The rate of perfect screw positioning was 94.9% in all patients who underwent robot-assisted spine surgery (498/525). After grouping studies based on the location of tracers, we found there was no significant difference in age, sex, height and body weight between the two groups. The screw accuracy (p < 0.01)was significantly higher in the spinous process group compared to the iliac group (97.5% versus 92.6%), but the operation time (p = 0.09) was longer in comparison. CONCLUSION: Placing the tracer on the spinous process as opposed to the iliac spine may result in longer procedure duration or increased bleeding, but enhanced satisfaction of screw placement.

Percutaneous thoraco-lumbar-sacral pedicle screw placement accuracy results from a multi-center, prospective clinical study using a skin marker-based optical navigation system.

STUDY DESIGN: Prospective multi-center study. OBJECTIVE: The study aimed to evaluate the accuracy of pedicle screw placement using a skin marker-based optical surgical navigation system for minimal invasive thoraco-lumbar-sacral pedicle screw placement. METHODS: The study was performed in a hybrid Operating Room with a video camera-based navigation system integrated in the imaging hardware. The patient was tracked with non-invasive skin markers while the instrument tracking was via an on-shaft optical marker pattern. The screw placement accuracy assessment was performed by three independent reviewers, using the Gertzbein grading. The screw placement time as well as the staff and patient radiation doses was also measured. RESULTS: In total, 211 screws in 39 patients were analyzed for screw placement accuracy. Of these 32.7% were in the thoracic region, 59.7% were in the lumbar region, and 7.6% were in the sacral region. An overall accuracy of 98.1% was achieved. No screws were deemed severely misplaced (Gertzbein grading 3). The average time for screw placement was 6 min and 25 secs (± 3 min 33 secs). The average operator radiation dose per subject was 40.3 µSv. The mean patient effective dose (ED) was 11.94 mSv. CONCLUSION: Skin marker-based ON can be used to achieve very accurate thoracolumbarsacral pedicle screw placements.

When giants talk; robotic dialog during thoracolumbar and sacral surgery.

BACKGROUND: Spinal trauma patients treated in a specialized hybrid operating room (OR) using two robotic systems communicating during surgery. METHODS: Retrospective review of patients with thoracolumbar or sacral fractures who underwent surgical fixation between Jan 2017 to Jan 2020 with robotic-guided percutaneous pedicle screw insertion in the specialized hybrid OR with Robotic flat panel 3D C-arm (ArtisZeego) for intraoperative interventional imaging connected with the robotic-guidance platform Renaissance (Mazor Robotics). RESULTS: Twenty eight surgeries were performed in 27 patients; 23 with traumatic spinal fractures, 4 with multi-level thoracolumbar compression fractures due to severe osteoporosis. Average patient age 49 (range 12-86). Average radiation exposure time 40 s (range 12-114 s). Average radiation exposure dose 11,584 ± SD uGym2 (range 4454-58,959). Lumber levels operated on were between T5 and S2 (shortest three vertebras and longest eight vertebras). 235 (range 5-11) trajectories were performed. All trajectories were accurate in all cases percutaneous pedicle screws placement was correct, without breach noted at the pedicle in any of the cases. No major complications reported. In all cases, follow-up X-rays showed adequate fracture reduction with restoration. CONCLUSIONS: Merging of surgical robotics technologies increases patient safety and surgeon and patient confidence in percutaneous spine traumatic procedures.

Predictors of accurate intrapedicular screw placement in single-level lumbar (L4-5) fusion: robot-assisted pedicle screw, traditional pedicle screw, and cortical bone trajectory screw insertion.

BACKGROUND: The superiorities in proximal facet joint protection of robot-assisted (RA) pedicle screw placement and screw implantation via the cortical bone trajectory (CBT) have rarely been compared. Moreover, findings on the screw accuracy of both techniques are inconsistent. Therefore, we analyzed the screw accuracy and incidence of facet joint violation (FJV) of RA and CBT screw insertion in the same study and compared them with those of conventional pedicle screw (PS) insertion. The possible factors affecting screw accuracy and FJV were also analyzed. METHODS: A total of 166 patients with lumbar degenerative diseases requiring posterior L4-5 fusion were retrospectively included and divided into the RA, PS, and CBT groups from March 2019 to December 2021. The grades of intrapedicular accuracy and superior FJV were evaluated according to the Gertzbin-Robbins scale and the Babu scale based on postoperative CT. Univariable and multivariable analyses were conducted to assess the possible risk factors associated with intrapedicular accuracy and superior FJV. RESULTS: The rates of optimal screw insertion in the RA, PS, and CBT groups were 87.3%, 81.3%, and 76.5%, respectively. The difference between the RA and CBT groups was statistically significant (P = 0.004). Superior FJVs occurred in 28.2% of screws in RA, 45.0% in PS, and 21.6% in CBT. The RA and CBT groups had fewer superior FJVs than the PS group (P = 0.008 and P < 0.001, respectively), and no significant difference was observed between the RA and CBT groups (P = 0.267). Multivariable analysis revealed that the CBT technique was an independent risk factor for intrapedicular accuracy. Furthermore, older age, the conventional PS technique and a smaller facet angle were independently associated with the incidence of superior FJVs. CONCLUSIONS: The RA and CBT techniques were associated with fewer proximal FJVs than the PS technique. The RA technique showed a higher rate of intrapedicular accuracy than the CBT technique. The CBT technique was independently associated with screw inaccuracy. Older age, conventional PS technique and coronal orientation of the facet join were independent risk factors for superior FJV.

Accuracy Assessment of Percutaneous Pedicle Screw Placement Using Cone Beam Computed Tomography with Metal Artifact Reduction.

Metal artifact reduction (MAR) algorithms are used with cone beam computed tomography (CBCT) during augmented reality surgical navigation for minimally invasive pedicle screw instrumentation. The aim of this study was to assess intra- and inter-observer reliability of pedicle screw placement and to compare the perception of baseline image quality (NoMAR) with optimized image quality (MAR). CBCT images of 24 patients operated on for degenerative spondylolisthesis using minimally invasive lumbar fusion were analyzed retrospectively. Images were treated using NoMAR and MAR by an engineer, thus creating 48 randomized files, which were then independently analyzed by 3 spine surgeons and 3 radiologists. The Gertzbein and Robins classification was used for screw accuracy rating, and an image quality scale rated the clarity of pedicle screw and bony landmark depiction. Intra-class correlation coefficients (ICC) were calculated. NoMAR and MAR led to similarly good intra-observer (ICC > 0.6) and excellent inter-observer (ICC > 0.8) assessment reliability of pedicle screw placement accuracy. The image quality scale showed more variability in individual image perception between spine surgeons and radiologists (ICC range 0.51−0.91). This study indicates that intraoperative screw positioning can be reliably assessed on CBCT for augmented reality surgical navigation when using optimized image quality. Subjective image quality was rated slightly superior for MAR compared to NoMAR.

CT-Navigated Spinal Instrumentations-Three-Dimensional Evaluation of Screw Placement Accuracy in Relation to a Screw Trajectory Plan.

Background and Objectives: In the literature, spinal navigation and robot-assisted surgery improved screw placement accuracy, but the majority of studies only qualitatively report on screw positioning within the vertebra. We sought to evaluate screw placement accuracy in relation to a preoperative trajectory plan by three-dimensional quantification to elucidate technical benefits of navigation for lumbar pedicle screws. Materials and Methods: In 27 CT-navigated instrumentations for degenerative disease, a dedicated intraoperative 3D-trajectory plan was created for all screws. Final screw positions were defined on postoperative CT. Trajectory plans and final screw positions were co-registered and quantitatively compared computing minimal absolute differences (MAD) of screw head and tip points (mm) and screw axis (degree) in 3D-space, respectively. Differences were evaluated with consideration of the navigation target registration error. Clinical acceptability of screws was evaluated using the Gertzbein−Robbins (GR) classification. Results: Data included 140 screws covering levels L1-S1. While screw placement was clinically acceptable in all cases (GR grade A and B in 112 (80%) and 28 (20%) cases, respectively), implanted screws showed considerable deviation compared to the trajectory plan: Mean axis deviation was 6.3° ± 3.6°, screw head and tip points showed mean MAD of 5.2 ± 2.4 mm and 5.5 ± 2.7 mm, respectively. Deviations significantly exceeded the mean navigation registration error of 0.87 ± 0.22 mm (p < 0.001). Conclusions: Screw placement was clinically acceptable in all screws after navigated placement but nevertheless, considerable deviation in implanted screws was noted compared to the initial trajectory plan. Our data provides a 3D-quantitative benchmark for screw accuracy achievable by CT-navigation in routine spine surgery and suggests a framework for objective comparison of screw outcome after navigated or robot-assisted procedures. Factors contributing to screw deviations should be considered to assure optimal surgical results when applying navigation for spinal instrumentation.

Augmented reality-navigated pedicle screw placement: a cadaveric pilot study.

PURPOSE: Augmented reality (AR) is an emerging technology with great potential for surgical navigation through its ability to provide 3D holographic projection of otherwise hidden anatomical information. This pilot cadaver study investigated the feasibility and accuracy of one of the first holographic navigation techniques for lumbar pedicle screw placement. METHODS: Lumbar computer tomography scans (CT) of two cadaver specimens and their reconstructed 3D models were used for pedicle screw trajectory planning. Planned trajectories and 3D models were subsequently uploaded to an AR head-mounted device. Randomly, k-wires were placed either into the left or the right pedicle of a vertebra (L1-5) with or without AR-navigation (by holographic projection of the planned trajectory). CT-scans were subsequently performed to assess accuracy of both techniques. RESULTS: A total of 18 k-wires could be placed (8 navigated, 10 free hand) by two experienced spine surgeons. In two vertebrae, the AR-navigation was aborted because the registration of the preoperative plan with the intraoperative anatomy was imprecise due to a technical failure. The average differences of the screw entry points between planning and execution were 4.74 ± 2.37 mm in the freehand technique and 5.99 ± 3.60 mm in the AR-navigated technique (p = 0.39). The average deviation from the planned trajectories was 11.21° ± 7.64° in the freehand technique and 5.88° ± 3.69° in the AR-navigated technique (p = 0.09). CONCLUSION: This pilot study demonstrates improved angular precision in one of the first AR-navigated pedicle screw placement studies worldwide. Technical shortcomings need to be eliminated before potential clinical applications.

Navigated percutaneous versus open pedicle screw implantation using intraoperative CT and robotic cone-beam CT imaging.

PURPOSE: Percutaneous paraspinal pedicle screw implantation (PPSI) reduces soft tissue trauma, blood loss, and postoperative pain but remains technically challenging and associated with radiation exposure and implant-related artefacts. Here, we determined the feasibility, screw accessibility, and the accuracy of navigated PPSI in the thoraco-lumbar sacral spine using intraoperative computed tomography (iCT) and robotic cone-beam CT (CBCT) imaging. METHODS: Between 2015 and 2018, 465 percutaneous paraspinal pedicle screws were implanted in 75 patients using iCT- or CBCT-based spinal navigation with 230 screws connected to rod reducers during screw assessment imaging (iCT 198; CBCT 32). Clinical and demographic data, intraoperative screw accessibility, and screw accuracy were analyzed and compared to a case-matched cohort of 75 patients undergoing navigated implantation of 481 pedicle screws through an open midline approach. RESULTS: Both iCT and CBCT permitted reliable assessment of each implanted screw, regardless of artifacts caused by rod reducers. Although overall accuracy for correct placement was comparable between PPSI and open surgery (PPSI 96.6%; Open 94.2%), PPSI compared favorably to open surgery regarding complete placement within the pedicle (PPSI 90.1%; Open 75.1%; p < 0.0001), regional placement accuracy in the lumbar (PPSI 97.8%; Open 91.5%; p < 0.001), and lumbar-sacral spine (PPSI 100%; Open 81.2%; p < 0.05), next to the duration of surgery and length of hospitalization. CONCLUSIONS: PPSI with iCT- and CBCT-based spinal navigation improves the accuracy, safety, and workflow of navigated spinal instrumentation. Next, a cost-effectiveness and outcome analysis should determine whether iCT and CBCT imaging are truly economically justified. These slides can be retrieved under Electronic Supplementary Material.

Does Navigation Improve Pedicle Screw Placement Accuracy? Comparison Between Navigated and Non-navigated Percutaneous and Open Fixations.

BACKGROUND: The aim of our study was to assess how a preoperative computed tomography (CT)-based navigation system affected the correctness and safety of transpedicular screw insertion, compared with standard techniques. METHOD: Between January 2012 and February 2014, 203 patients underwent thoracic and lumbar fixation, with open and percutaneous techniques; 218 screws were implanted through an open navigated technique (1.0 Spine & Trauma 3d ver. 2.0 BrainLab, Feldkirchen Germany) in 43 patients; 220 screws were inserted with an open free-hand technique in 45 patients; 230 screws were implanted in 56 patients using percutaneous CT-based navigation; and 236 screws were inserted in 59 patients using a percutaneous fluoroscopy-guided technique. To our knowledge, this is the first work comparing these four different techniques. The position of each screw was evaluated on CT scan reconstruction and classified according to a four-point grading scale (grade 0: no breach, grade 1: breach < 2 mm, grade 2: breach between 2 and 4 mm; grade 3: breach >4 mm). Statistical analysis was assessed by two-way analysis of variance (ANOVA) t test, while the Fisher least significant difference (LSD) method was employed to determine statistical significance. RESULTS: Statistical analysis showed a significant difference in accuracy between the open CT-based navigation and the percutaneous CT-based navigation techniques (P= 0.0263) and between the open CT-based navigation and the percutaneous fluoroscopy-guided techniques (P=0.0258): a particular difference was observed in anterior misplacement between open CT-based navigation and the percutaneous fluoroscopy-guided technique (P= 0.0153). CONCLUSIONS: Our results confirm the advantages of the navigation technique, which ensures greater accuracy, in open as well as percutaneous procedures.

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

INTRODUCTION: 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. METHOD: 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). RESULTS: 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. CONCLUSION: 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.

Analysis of the Screw Accuracy and Postoperative Efficacy of Screw Placement in Single Position and Bipedal Position in Robot-Assisted Oblique Lumbar Interbody Fusion: Preliminary Results of Mazor X Stealth Usage.

OBJECTIVE: Traditional manual OLIF combined with pedicle screw implantation has many problems of manual percutaneous screw implantation, such as high difficulty of screw placement, many fluoroscopies, long operation time, and many adjustments, resulting in greater trauma. The robot can perform various types of screw placement in the lateral recumbent position, which allows OLIF combined with posterior screw placement surgery to be completed in a single position. To compare the screw accuracy and initial postoperative results of oblique anterior lumbar fusion with robot-assisted screw placement in the lateral position and screw placement in the prone position for the treatment of lumbar spondylolisthesis. METHODS: From May to June 2022, 45 patients with single-segment lumbar spondylolisthesis underwent Mazor X-assisted oblique lumbar fusion in one position and Renaissance-assisted surgery in two different positions, and screw accuracy was assessed on computed tomography scans according to a modified Gertzbein-Robbins classification. Patients were divided into a single position group and a bipedal position group (the lateral position for complete oblique lumbar fusion and then changed to the prone position for posterior screw placement), and the perioperative parameters, including operative time, number of fluoroscopies, and operative complications, were recorded separately. The results of the clinical indicators, such as the visual analog scale (VAS) for back and leg pain and the Oswestry Disability Index (ODI) score, were obtained. RESULTS: There were no significant differences in the patients' demographic data between the two groups. The single position group had a shorter operative time and fewer fluoroscopies than the bipedal position group; the single position group had a higher percentage of screw accuracy at the A level than the bipedal position group, but there was no statistically significant difference between the two groups at the acceptable level (A + B) (p > 0.05). The single-position group had better outcomes at the 1-week postoperative follow-up back pain VAS scores (p < 0.05). There was no statistically significant difference in the postoperative leg pain VAS scores or the ODI scores when compared to the control group. CONCLUSION: Robot-assisted lateral position oblique lumbar interbody fusion with pedicle screw placement has the same accuracy as prone positioning. Single position surgery can significantly shorten the operation time and reduce the fluoroscopy. There was no significant difference in the long-term efficacy between the two groups.

Accuracy of screw placement during vertebral body tethering using fluoroscopic guidance and anatomic landmarks.

PURPOSE: To determine the accuracy of screw placement using fluoroscopy and anatomic landmarks during vertebral body tethering (VBT) surgery. METHODS: Ten patients with 73 VBT screws were converted to posterior spinal fusion (PSF) after continued curve progression. The positions of each VBT screw were analyzed using intraoperative computed tomography (CT) scans performed for image guidance during VBT. Differences for screws placed using an open versus thoracoscopic approach were noted for the screw position in each vertebra, distance from the spinal canal, unicortical versus bicortical placement, the distance of screw tips from the thoracic aorta, and impingement of screws on adjacent rib heads. RESULTS: Seventy three (73) screws in ten (10) patients were available for analysis. Only 21% of screws were placed traversing the middle one-third of the vertebral body, without spinal canal penetration, with the distal tip placed unicortically or bicortically as planned, and without touching the thoracic aorta. The rates of non-ideal screw placement were not significantly different for screws placed via thoracoscopic versus open approaches. Five (5) screws (6.8%) penetrated the spinal canal 1-2 mm, but without known clinical sequelae. CONCLUSION: The majority of VBT screws available for analysis were placed in non-ideal positions, suggesting that accurate screw placement using intraoperative fluoroscopy and anatomic landmarks can be challenging, but without adverse clinical consequences.

Advancements in pelvic ring fracture surgery: Assessing INFIX screw placement accuracy with CT navigation.

The management of unstable pelvic ring fractures, typically resulting from high-energy trauma, presents a significant clinical challenge due to the complexity of injuries. While effective in many cases, the traditional stabilization methods are fraught with various complications that can significantly impact patient recovery and quality of life (QOL). This study aims to evaluate the efficacy and precision of the anterior subcutaneous internal fixator (INFIX) technique when used with intraoperative computed tomography (CT) navigation, a novel approach intended to mitigate the limitations of conventional treatment modalities. Our retrospective case series encompasses 43 patients who sustained traumatic pelvic injuries and were subsequently treated with the INFIX technique from December 2020 to January 2024. The focus of this analysis was to assess the accuracy of INFIX screw placement facilitated by intraoperative CT navigation. A total of 81 INFIX screws were inserted, and our study findings reveal a high level of precision in screw placement, with only one screw deviating, resulting in an inaccuracy rate of merely 1.2 %. This highlights the significant advantage provided by intraoperative CT navigation. The high level of accuracy not only enhances the stability of the pelvic fixation but also substantially reduces the risk of complications commonly associated with screw misplacement, such as abdominal damage, vascular injury, and issues related to incorrect hardware positioning. In conclusion, the integration of the INFIX technique with intraoperative CT navigation in the treatment of unstable pelvic ring fractures represents a significant advancement in orthopedic trauma surgery. This study provides compelling evidence supporting the efficacy and precision of this approach, suggesting its potential as a superior alternative to traditional fixation methods. Further research, ideally through prospective studies involving larger patient cohorts, is needed to validate these findings and explore the long-term implications of this technique on patient recovery and QOL.

Comparison of 3D-navigation and fluoroscopic guidance in percutaneous pedicle screw placement for traumatic fractures of the thoracolumbar junction.

Introduction: Fractures of the thoracolumbar junction are the most common vertebral fractures and can require surgical treatment. Several studies have shown that the accuracy of pedicle screw placement can be improved by the use of 3D-navigation. Still only few studies have focused on the use of navigation in traumatic spine injuries. Research question: The aim of this study was to compare the screw placement accuracy and radiation exposure for 3D-navigated and fluoroscopy-guided percutaneous pedicle screw placement in traumatic fractures of the thoracolumbar junction. Materials and methods: In this single-center study 25 patients undergoing 3D-navigated percutaneous pedicle screw placement for traumatic fractures of the thoracolumbar junction (T12-L2) were compared to a control group of 25 patients using fluoroscopy. Screw accuracy was determined in postoperative CT-scans using the Gertzbein-Robbins classification system. Additionally, duration of surgery, dose area product, fluoroscopy time and intraoperative complications were compared between the groups. Results: The accuracy of 3D-navigated percutaneous pedicle screw placement was 92.66 % while an accuracy of 88.08 % was achieved using standard fluoroscopy (p = 0.19). The fluoroscopy time was significantly less in the navigation group compared to the control group (p = 0.0002). There were no significant differences in radiation exposure, duration of surgery or intraoperative complications between the groups. Discussion and conclusion: The results suggest that 3D-navigation facilitates higher accuracy in percutaneous pedicle screw placement of traumatic fractures of the thoracolumbar junction, although limitations should be considered. In this study 3D-navigation did not increase fluoroscopy time, while radiation exposure and surgery time were comparable.

A novel technique for C1-C2 posterior screw insertion using patient-specific guides created by CT-based 3D printing.

C1-C2 fixation has been developed for the rigid fusion of atlantoaxial instability. C1 lateral mass screw (C1 LMS)-C2 pedicle screw fixation is used more frequently due to its rigid fixation and high bone fusion rate. However, C1 screw placement is relatively unsafe even with recently developed image-based navigation systems. Patient-specific screw guide templates (PSGT) were developed to improve the accuracy and safety of C1 screw placement. Herein, we investigated the outcomes of the C1-C2 posterior fixation technique using PSGT. This was a retrospective study of six patients who underwent posterior cervical spinal fusion using the PSGT between January 2022 and April 2023. Operative time, estimated blood loss, intraoperative radiation dose, surgical cost, and screw placement accuracy were evaluated and compared with those achieved with preoperative CT-based navigation (navigation group, n = 15). Screw accuracy was assessed using Neo's classification. PSGT showed good results, although the differences were not statistically significant (operation time: 104.3 ± 9.7 min vs 116.4 ± 20.8 min; estimated blood loss: 56.7 ± 72.4 mL vs 123.2 ± 162.3 mL; and radiation dose: 1.8 ± 1.2 mSv vs 2.6 ± 0.8 mSv, respectively). PSGT was particularly better in terms of the accuracy of C1 LMS (PSGT: 100%, navigation: 83.3%). The deviation at the entry point was minimal, and the difference between the sagittal and transversal angles from the preoperative plan was small. We investigated the clinical efficacy of using the PSGT for C1-C2 posterior fixation. PSGT improved the accuracy of C1 LMS insertion.

The Child's Age and the Size of the Curvature Do Not Affect the Accuracy of Screw Placement with the Free-Hand Technique in Spinal Deformities in Children and Adolescents.

BACKGROUND: The current method of treatment of spinal deformities would be almost impossible without pedicle screws (PS) placement. There are only a few studies evaluating the safety of PS placement and possible complications in children during growth. The present study was carried out to evaluate the safety and accuracy of PS placement in children with spinal deformities at any age using postoperative computed tomography (CT) scans. METHODS: 318 patients (34 males and 284 females) who underwent 6358 PS fixations for pediatric spinal deformities were enrolled in this multi-center study. The patients were divided into three age groups: less than 10 years old, 11-13 years old, and 14-18 years old. These patients underwent postoperative CT scans and were analyzed for pedicle screw malposition (anterior, superior, inferior, medial, and lateral breaches). RESULTS: The breach rate was 5.92% for all pedicles. There were 1.47% lateral and 3.12% medial breaches for all pedicles with tapping canals, and 2.66% lateral and 3.84% medial breaches for all pedicles without a tapping canal for the screw. Of the 6358 screws placed in the thoracic, lumbar, and sacral spine, 98% of the screws were accurately placed (grade 0, 1, and juxta pedicular). A total of 56 screws (0.88%) breached more than 4 mm (grade 3), and 17 (0.26%) screws were replaced. No new and permanent neurological, vascular, or visceral complications were encountered. CONCLUSIONS: The free-hand technique for pedicle screw placement in the acceptable and safety zone in pedicles and vertebral bodies was 98%. No complications associated with screw insertion in growth were noted. The free-hand technique for pedicle screw placement can be safely used in patients at any age. The screw accuracy does not depend on the child's age nor the size of the deformity curve. Segmental instrumentation with posterior fixation in children with spinal deformities can be performed with a very low complication rate. Navigation of the robot is only an auxiliary tool in the hands of the surgeons, and the result of the work ultimately depends on the surgeons.

Robotic and navigated pedicle screws are safer and more accurate than fluoroscopic freehand screws: a systematic review and meta-analysis.

BACKGROUND CONTEXT: Navigated and robotic pedicle screw placement systems have been developed to improve the accuracy of screw placement. However, the literature comparing the safety and accuracy of robotic and navigated screw placement with fluoroscopic freehand screw placement in thoracolumbar spine surgery has been limited. PURPOSE: To perform a systematic review and meta-analysis of randomized control trials that compared the accuracy and safety profiles of robotic and navigated pedicle screws with fluoroscopic freehand pedicle screws. STUDY DESIGN/SETTING: Systematic review and meta-analysis PATIENT SAMPLE: Only randomized controlled trials comparing robotic-assisted or navigated pedicle screws placement with freehand pedicle screw placement in the thoracolumbar spine were included. OUTCOME MEASURES: Odds ratio (OR) estimates for screw accuracy according to the Gertzbein-Robbins scale and relative risk (RR) for various surgical complications. METHODS: We systematically searched PubMed and EMBASE for English-language studies from inception through April 7, 2022, including references of eligible articles. The search was conducted according to PRISMA guidelines. Two reviewers conducted a full abstraction of all data, and one reviewer verified accuracy. Information was extracted on study design, quality, bias, participants, and risk estimates. Data and estimates were pooled using the Mantel-Haenszel method for random-effects meta-analysis. RESULTS: A total of 14 papers encompassing 12 randomized controlled trials were identified (n=892 patients, 4,046 screws). The pooled analysis demonstrated that robotic and navigated pedicle screw placement techniques were associated with higher odds of screw accuracy (OR 2.66, 95% CI 1.24-5.72, p=.01). Robotic and navigated screw placement was associated with a lower risk of facet joint violations (RR 0.09, 95% CI 0.02-0.38, p<.01) and major complications (RR 0.31, 95% CI 0.11-0.84, p=.02). There were no observed differences between groups in nerve root injury (RR 0.50, 95% CI 0.11-2.30, p=.37), or return to operating room for screw revision (RR 0.28, 95% CI 0.07-1.13, p=.07). CONCLUSIONS: These estimates suggest that robotic and navigated screw placement techniques are associated with higher odds of screw accuracy and superior safety profile compared with fluoroscopic freehand techniques. Additional randomized controlled trials will be needed to further validate these findings.

Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database.

STUDY DESIGN: Cross-Sectional Analysis. OBJECTIVES: To summarize medical device reports (MDRs) between August 1, 2017 and November 30, 2021 relating to robot-assisted spine systems within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: The MAUDE database was abstract for all MDRs relating to each FDA-approved robot-assisted spine system. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific robot-assisted spine systems and reported events as detailed by the MDRs. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). RESULTS: There were 263 MDRs consisting of 265 reported events. Misplaced screws represented 61.5% (n = 163) of reported events. Of the 163 reported events, 57.1% (n = 93) described greater than 1 misplaced screw, 15.3% (n = 25) required return to the operating room, 8.6% (n = 14) resulted in neurologic injury, 4.3% (n = 7) resulted in dural tear, and 1.2% (n = 2) resulted in hemorrhage or bleeding. Reported events other than misplaced screws included system imprecision detected prior to screw placement (58/265, 21.9%), mechanical failure (23/265, 8.7%), and software failure (18/265, 6.8%). CONCLUSIONS: As more robot-assisted spine systems gain FDA approval and the adoption of these systems continues to grow, documenting and understanding the range of reported events associated with each "tool" is imperative to balancing patient safety with surgical innovation. This study of the MAUDE database provides a unique summary of reported events associated with robot-assisted spine systems that is not directly linked to a research setting.