Robotic Pedicle Screw Placement with 3D MRI Registration: Moving Towards Radiation Free Robotic Spine Surgery.

BACKGROUND CONTEXT: Preoperative imaging for lumbar spine surgery often includes magnetic resonance imaging (MRI) for soft tissues and computer tomography (CT) for bony detail. While CT scans expose patients to ionizing radiation, whereas MRI scans do not. Emerging MRI techniques allow CT-like three-dimensional (3D) visualization of bony structures, potentially removing the need for ionizing radiation from CT scans. PURPOSE: This study aims to explore the accuracy of robot-assisted lumbar pedicle screw placement based on preoperative CT-like 3D MRI as the data source for robotic registration. STUDY DESIGN: Human cadaveric study. METHODS: CT-like 3D MRI scans of the lumbar spine were acquired in ten human cadavers. A robotic navigation platform was used to plan and navigate pedicle screw placement based on the CT-like 3D MRI. Postoperative CT scans assessed the accuracy of screw positioning compared to preoperative planning based on the Gertzbein-Robbins scale (GRS) and by direct measurement (mm). RESULTS: A total of 100 lumbar pedicle screws were robotically placed in ten cadavers (L1 through L5 bilaterally) based on CT-like 3D MRI. On postoperative CT evaluation, 99.0% of the positioned screws achieved an acceptable grade on the GRS (Grade A: n = 89 or Grade B: n = 10), with 89.0% classified as Grade A and 10.0% as Grade B. Meaning that 89.0% of screws were fully contained within the pedicle (GRS A), and 10% had a minor cortical breach <2mm (GRS B). The median deviation from the planned trajectory was 0.2 mm (axial IQR: 0.1 to 0.5 mm; sagittal: IQR: 0.1 to 0.4 mm), in both axial and sagittal planes. CONCLUSION: This study showed that image registration of CT-like 3D MRI for robotic-assisted spine surgery is technically feasible and that accurate pedicle screw placement can be achieved without preoperative CT. Each CT-like 3D MRI was successfully registered for robotic navigation. CLINICAL SIGNIFICANCE: The results suggest that CT-like 3D MRI has the potential to be a radiation-free alternative for preoperative planning and navigation in lumbar spine instrumentation procedures.

O-arm navigation without apnoea in thoracolumbar and lumbar spine surgery: Outcomes and considerations in a prospective study.

Background: Intra operative three dimensional navigation-assisted pedicle screw insertion typically requires apnoea for reliable image production. However this carries potential risks to the physiologically compromised patients such as patients having COPD, obesity, cardiac illnesses, and anaemia. In such patients' safe apnoea time may be as low as 1 min, and can cause life threatening complications. Therefore, this study was done to evaluate the accuracy of thoracolumbar and lumbar pedicle screw insertion using O-arm without using apnoea during imaging, to prevent such possible complications. Methods: This is a single centre prospective study of 238 patients treated with pedicle screw implantation under O-arm guidance, without using apnoea while imaging. The pedicle breach rate during screw insertion was graded on Gertzbein classification. Also, two senior spine surgeons independently evaluated motion artifacts in the intra operative images and rated them as 'Significant' or 'Non-Significant' for the procedure. Values of p < 0.05 were considered statistically significant. Results: Despite not using apnoea in 238 patients with 1120 screws, there were nil screw related complications. Only in one paediatric case of dorsal spine deformity, there were blurred and inaccurate images because of chest expansion, without apnoea. Hence he was given apnoea to render the image reliable for pedicle screw insertion. The screw placement in the pedicles was checked intraoperatively and graded for breach. Grade 2 breach were seen in only 2 cases (n = 3 screws) which were revised intra operatively. The interobserver agreement on motion artifacts was good (κ = 0.565, p < 0.001). Conclusions: The results of pedicular screw insertion performed without induced apnea are comparable to those achieved with apnea when using O-arm imaging. This technique has proven to be a safe and reliable method for pedicle screw insertion in the thoracolumbar and lumbar spine, potentially mitigating physiological complications. Nonetheless, even minor motion artifacts, on the order of a few millimeters, can significantly impact outcomes in the cervical and upper thoracic spine. Therefore, further research is warranted to evaluate the efficacy and safety of this approach in these regions of the spine.

Advancing the design of interspinous fixation devices for improved biomechanical performance: dual vs. single-locking set screw mechanisms and symmetrical vs. asymmetrical plate designs.

Background: Interspinous devices were introduced in the field of spine surgery as an alternative to traditional pedicle screw fixation in selected patients for treatment of spinal stenosis and fixation. These devices designs have evolved from non-fixated extension blocks to sophisticated interspinous fixation devices (IFDs). There is an absence of literature comparing the biomechanical fixation strength of different IFD plate designs and the role of set screw locking systems. The aim of this study was to evaluate fixation strengths by bench testing static disassembly and pullout strength of two dissimilar IFD designs and locking mechanisms. We hypothesized that the InSpan (InSpan LLC, Burlington, MA, USA) dual-locking symmetrically IFD plate designed will have stronger fixation than the Aspen (ZimVie, Parsippany, NJ, USA) single-locking asymmetric IFD plate design. Methods: We conducted two biomechanical bench tests to evaluate the load to failure locking characteristics of symmetrical InSpan and asymmetrical Aspen IFD designs. Static pullout testing involved locking each IFD to the stainless steel and 40 pcf cellular polyurethane foam and measuring pullout load and displacement six times. Seven InSpan and two Aspen IFDs (including the "used" IFDs from the pullout testing) underwent static disassembly tests using a pair of disassembly fixtures positioned between the IFD plates to measure disassembly force and displacement. All tests were performed under ambient conditions using an INSTRON 8874 Bi-Axial Tabletop Servohydraulic Dynamic Testing System (INSTRON, Norwood, MA, USA), and data was collected at a 0.2 mm/s displacement control rate until the test was stopped when there was a drop in the continuously increasing force against resistance (gross failure). Results: The InSpan IFD experienced 94.81% higher resistance to pullout compared to the Aspen IFD in static pullout testing (P<0.05), owing to its notably larger footprint area of 69.8%. Gross failure for both IFD implant designs occurred at the foam block-block interface. In static disassembly testing, pristine InSpan required 60.7% higher force over pristine Aspen and 401.3% for "used" IFDs. Gross failure was characterized by the gradual distraction of the plates and material removal at the set screw contact points. Implant failure at the block-implant interface emphasized the pivotal role of teeth design and the contact surface area of the plates in ensuring stability. Conclusions: The dual-locking symmetrical InSpan IFD outperformed single-locking asymmetric Aspen IFD in both static disassembly and pullout bench tests. This highlights the benefits of InSpan's improved design and its potential for enhanced long-term stability in spinal fixation applications.

A comparative cadaveric biomechanical study of bilateral FacetFuse® transfacet pedicle screws versus bilateral or unilateral pedicle screw-rod construct.

Background: Achieving optimal immediate stability is crucial in lumbar fusion surgeries. Traditionally, four pedicle screws have been utilized to provide posterior stability at the L5-S1 level. However, the use of bilateral transfacet pedicle screws (TFPS) as an alternative construct has shown promising results in terms of biomechanical stability. This research paper investigates the biomechanical stability of TFPS with a lag design in comparison to equivalent-sized unilateral or bilateral fully threaded pedicle screw-rod (PSR) constructs at the L5-S1 disc level. The study assesses the immediate stability achieved by these constructs which have clinical implications in achieving lumbar segment fusion. We hypothesized that bilateral TFPS will yield immediate lumbar fixation that is comparable to unilateral or bilateral PSR constructs. Methods: Cadaveric biomechanical testing was conducted in vitro to evaluate the stability of posterior fixation using bilateral TFPS (FacetFuse®, LESSpine, Burlington, MA, USA), bilateral and unilateral PSR (PedFuse Return, LESSpine, Burlington, MA, USA) constructs measuring 5.0 mm × 40 mm. A comprehensive analysis of range of motion (ROM) and stability under various loading conditions was performed to a maximum of 7.5 Nm. The constructs were assessed for their ability to provide immediate stability at the L5-S1 disc level. Results: Fourteen specimens were analyzed with an average age of 53.14±10.99 years and comparable bone mineral density. TFPS demonstrated a reduced ROM that was notably lower than that of unilateral PSR in all loading modes and was comparable to bilateral PSR, especially in extension and axial rotation (AR). The unilateral and bilateral PSR groups differed notably in lateral bending (LB) and AR. Conclusions: Bilateral TFPS demonstrated superior immediate stability than unilateral PSR and was an equivalent substitute to bilateral PSR constructs at the L5-S1 disc level. Further clinical investigations are necessary to validate these results and ascertain the long-term outcomes and advantages associated with the use of bilateral TFPS as an alternative construct. Our findings showed that bilateral TFPS could potentially reduce the number of required pedicle screws while achieving comparable stability in lumbar fusion procedures.

A novel pedicle screw design to maximize screw-bone interface strength using finite element analysis and design of experiment techniques.

Study Design: Basic study. Purpose: This study aimed to utilize finite element (FE) analysis and design of experiment (DoE) techniques to propose and optimize a novel pedicle screw design and compare its pull-out force with that of a control device. Overview of Literature: Pedicle screw-based fixation is the gold-standard treatment for spine diseases, particularly in fusion procedures. However, pedicle screw loosening and breakage still occur in osteoporotic and non-osteoporotic patients. This research investigates screw design modifications to enhance screw-bone interface strength and reduce the likelihood of loosening. Methods: We conceptualized a novel pedicle screw considering vertebral bone morphology and strength differences. A validated FE model was developed and used in conjunction with DoE to determine the screw՚s optimum geometrical parameters. The FE model was validated through simulation and laboratory experiments using the control device. The optimized thread profiles for cortical bone and cancellous bone were determined, with pull-out force as the primary factor for screw design evaluation. Results: FE analysis results for the control device closely matched experimental results, with less than 5% difference. The chosen unique pitch/depth ratio showed maximum pull-out force for cortical bone, while DoE enabled the optimization of design parameters for cancellous bone. The optimized pedicle screw exhibited a 15% increase in pull-out force compared to the control device. Conclusions: The study proposes a novel pedicle screw design with better pull-out strength than the control device. Combining FE analysis with DoE is an effective approach for screw design optimization, reducing the need for extensive prototyping tests. A two-variable analysis suffices for optimizing cortical bone design parameters, while a multi-variable analysis is more effective for optimizing cancellous bone design parameters.

Robotic spine systems: overcoming surgeon experience in pedicle screw accuracy: a prospective study.

Study Design: Prospective single-center study. Purpose: To compare the accuracy of pedicle screws placed by freehand and under fluoroscopy and robotic assistance with intraoperative image acquisition. Overview of Literature: Pedicle screws are the most commonly used spinal anchors owing to their ability to stabilize all three spinal columns. Various techniques such as freehand, fluoroscopy-assisted, and navigation-assisted pedicle screw placements have been used with varying degrees of accuracy. Most studies on robotic-assisted pedicle screw placement have utilized preoperatively acquired computed tomography scans. To our knowledge, this is the only study in the literature that compared freehand with fluoroscopy-guided and robotic-assisted pedicle screw insertion with freehand and fluoroscopy. Methods: In this prospective study, a total of 1,120 pedicle screws were placed in the freehand group (n=175), 1,250 in the fluoroscopyassisted group (n=172), and 1,225 in the robotic-assisted group (n=180). Surgical parameters and screw accuracy were analyzed between the three groups. The preoperative plan overlapped with the postoperative O-arm scan to determine if the screws were executed as planned. Results: The frequency of clinically acceptable screw placement (Gertzbein-Robbins grades A and B) in the freehand, fluoroscopy-assisted, and robotic-assisted groups were 97.7%, 98.6%, and 99.34%, respectively. With robotic assistance, an experience-neutralizing effect implied that surgeons with varying levels of experience achieved comparable pedicle screw accuracy, blood loss, O-arm time, robot time, and time per screw. No significant difference in these parameters was found between surgeries commencing before and after 2 PM. No significant differences were noted between the planned and executed screw trajectories in the robotic-assisted group irrespective of surgical experience. Conclusions: The third-generation robotic-assisted pedicle screw placement system used in conjunction with intraoperative threedimensional O-arm imaging consistently demonstrates safe and accurate screw placement with an experience-neutralizing effect.

Expert consensus on the clinical application of cortical bone trajectory for lumbar pedicle screws: results from a modified Delphi study.

Study Design: A modified Delphi study. Purpose: This study sought to establish expert consensus on the use of cortical bone trajectory (CBT) for lumbar pedicle screws. Overview of Literature: The CBT technique is widely used in the treatment of various degenerative lumbar diseases because it reduces surgical time, soft tissue exposure, and blood loss; improves biomechanical stability; and allows for faster patient recovery. However, as an emerging surgical technique, CBT remains controversial in terms of preoperative evaluation methods, key surgical techniques, complication prevention and treatment, postoperative follow-up, and other aspects, resulting in unclear indications and contraindications for some doctors and posing great challenges to the steady promotion of this technique. Methods: From May 2021 to August 2021, panelists were chosen to collect expert feedback using the modified Delphi method, and 74 spine surgeons from across China agreed to participate. Four rounds were conducted: one in-person meeting and three subsequent survey rounds. Each question received at least 70.0% agreement, indicating a consensus. The grade A, B, and C recommendation were defined as having ≥90.0%, 80.0%-89.9%, and 70.0%-79.9% agreement on each question, respectively. Results: The panelist group consisted of 74 experts, and 72, 70, and 69 questionnaires were collected in three rounds, respectively. In total, 24 questions with 59 options reached consensus after the Delphi rounds, including indications (adjacent vertebral diseases after lumbar internal fixation) and contraindications (previous surgery or bone destructive diseases lead to the destruction or absence of bone in the lamina or isthmus); advantages (intraoperative traction of paravertebral soft tissue is small) and disadvantages (not three-column fixation.); preoperative evaluation; complications; and postoperative follow-up evaluation, of CBT. Conclusions: The modified Delphi method achieved expert consensus on the clinical use of CBT for lumbar pedicle screws. This consensus document establishes clear guidelines for indications, contraindications, surgical techniques, and postoperative management, thereby enhancing clinical decision-making and promoting the safe and effective use of CBT. While the initial study focused on Chinese surgeons, future research will seek to validate and expand these findings from a broader international perspective.

Neuro Navigation Versus Conventional Spinal Techniques in Analyzing Nerve Injury and Anatomical Accuracy: A Systematic Review.

Neuronavigation, a computer-assisted surgical technique, enhances the accuracy of spinal surgery by using medical imaging to guide the surgeon's instruments. This method mitigates the serious complications of screw misplacement, such as dural tears, nerve damage, vascular injuries, and internal organ damage, by integrating pre-operative imaging data with real-time intraoperative sensor readings. Because of this integration, it is possible to visualize the spine in three dimensions, guaranteeing accurate instrument placement and greatly lowering the risk of complications. Despite its growing popularity, the benefits of neuronavigation in spinal instrumentation are debated. While some studies report improved accuracy in pedicle screw placement, others find no significant difference compared to conventional freehand techniques. Further research is required to determine the long-term benefits of neuronavigation, including its impact on patient outcomes, like reduced pain and improved function. This systematic review will evaluate the evidence on the risks and benefits of neuronavigation in spinal instrumentation surgery, compared to conventional techniques.

Stability of medially and laterally malpositioned screws: a biomechanical study on cadavers.

BACKGROUND CONTEXT: Pedicle screw instrumentation is widely used in spine surgery. Axial screw misplacement is a common complication. In addition to the recognized neurovascular risks associated with screw misplacement, the biomechanical stability of misplaced screws remains a subject of debate. PURPOSE: The present study investigates whether screw misplacement in the lumbar spine reduces mechanical screw hold. STUDY DESIGN/SETTING: Cadaveric biomechanical study. METHODS: Pedicle screw (mis)placement was planned for 12 fresh frozen cadaveric spines between the T12 and the L5 levels. The screws were then implanted into the vertebrae with the help of 3D-printed template guides. Pre- and postinstrumentation computed tomography (CT) scans were acquired for instrumentation planning and quantification of the misplacement. The instrumented vertebrae were potted into CT transparent boxes using Polymethyl methacrylate and mounted on a standardized biomechanical setup for pull-out (PO) testing with uniaxial tensile load. RESULTS: The bone density of all the specimens as per HU was comparable. The predicted pull-out force (POF) for screws medially misplaced by 2 , 4, and 6 mm was respectively 985 N (SD 474), 968 N (SD 476) and 822 N (SD 478). For screws laterally misplaced by 2 , 4, and 6 mm the POF was respectively 605 N (SD 473), 411 N (SD 475), and 334 N (SD 477). Screws that did not perforate the pedicle (control) resisted pull-out forces of 837 N (SD 471). CONCLUSIONS: Medial misplacement is associated with increased axial screw hold against static loads compared to correctly placed screws and laterally placed screws. CLINICAL SIGNIFICANCE: In clinical settings, the reinsertion of medially misplaced screws should primarily aim to prevent neurological complications while the reinsertion of lateral misplaced screws should aim to prevent screw loosening.

Development and validation of deep learning models for identifying the brand of pedicle screws on plain spine radiographs.

Background: In spinal revision surgery, previous pedicle screws (PS) may need to be replaced with new implants. Failure to accurately identify the brand of PS-based instrumentation preoperatively may increase the risk of perioperative complications. This study aimed to develop and validate an optimal deep learning (DL) model to identify the brand of PS-based instrumentation on plain radiographs of spine (PRS) using anteroposterior (AP) and lateral images. Methods: A total of 529 patients who received PS-based instrumentation from seven manufacturers were enrolled in this retrospective study. The postoperative PRS were gathered as ground truths. The training, validation, and testing datasets contained 338, 85, and 106 patients, respectively. YOLOv5 was used to crop out the screws' trajectory, and the EfficientNet-b0 model was used to develop single models (AP, Lateral, Merge, and Concatenated) based on the different PRS images. The ensemble models were different combinations of the single models. Primary outcomes were the models' performance in accuracy, sensitivity, precision, F1-score, kappa value, and area under the curve (AUC). Secondary outcomes were the relative performance of models versus human readers and external validation of the DL models. Results: The Lateral model had the most stable performance among single models. The discriminative performance was improved by the ensemble method. The AP + Lateral ensemble model had the most stable performance, with an accuracy of 0.9434, F1 score of 0.9388, and AUC of 0.9834. The performance of the ensemble models was comparable to that of experienced orthopedic surgeons and superior to that of inexperienced orthopedic surgeons. External validation revealed that the Lat + Concat ensemble model had the best accuracy (0.9412). Conclusion: The DL models demonstrated stable performance in identifying the brand of PS-based instrumentation based on AP and/or lateral images of PRS, which may assist orthopedic spine surgeons in preoperative revision planning in clinical practice.

The Legacy of Harrington's Rod and the Evolution of Long-Segment Constructs in Spine Surgery.

This paper delves into the historical evolution of spinal surgery, focusing on the pivotal role of the Harrington rod in treating spinal deformities. Introduced in 1955, the Harrington rod marked a significant breakthrough in neurosurgery, especially for scoliosis treatment, by offering a novel approach to spinal stabilization. Through a retrospective analysis, this study examines the development and impact of the Harrington rod, highlighting Dr. Paul Harrington's contributions to spinal surgery. His innovative technique revolutionized the management of spinal deformities, laying the groundwork for future advancements in spinal instrumentation. Despite initial skepticism, Harrington's methods gained acceptance, significantly influencing neurosurgical practices and patient outcomes. This study also explores subsequent advancements that built on Harrington's work, including the transition to long-segment spine constructs and the introduction of segmental pedicle screws, which allowed for more precise deformity correction. Reflecting on Harrington's legacy, this paper acknowledges the continuous evolution of spinal surgery, driven by the interplay between clinical challenges and technological innovations. Harrington's pioneering spirit exemplifies the ongoing pursuit of better surgical outcomes, underscoring the importance of innovation in the field of neurosurgery.

Improving C1 Pedicle Screw Placement for Atlantoaxial Instability with Ultrasonic Bone Burr Assistance.

OBJECTIVE: This study aims to evaluate the safety and efficacy of the ultrasonic bone burr (UBB) in facilitating C1 pedicle screw placement for atlantoaxial instability treatment, compared to the conventional high-speed drill (HSD) technique. METHODS: A retrospective analysis was conducted on patients undergoing posterior screw-rod fixation for atlantoaxial instability between December 2017 and July 2023. The patients were divided into 2 groups based on the tools used for screw placement: UBB and HSD. Data on surgical duration, estimated blood loss, spinal cord and arterial injury incidence, screw placement accuracy, neurological status measured by the Japanese Orthopedic Association score, and fusion rates were collected and analyzed. RESULTS: Thirteen patients received C1 pedicle screw placement via UBB facilitation, while 8 were treated using the HSD approach. The UBB group showed a significant reduction in blood loss and operation time compared to the HSD group (P = 0.002 and P < 0.001, respectively). No spinal cord or arterial injuries occurred in either group. Optimal screw placement was confirmed in all UBB cases versus 87.5% in the HSD group (P = 0.139). Both groups demonstrated significant improvements in Japanese Orthopedic Association scores with no intergroup difference. The fusion rate was 100% in the UBB group and 87.5% in the HSD group, not statistically different (P = 0.381). CONCLUSIONS: UBB is a viable alternative for C1 pedicle screw placement, associated with reduced blood loss and shorter operation time, while achieving comparable clinical outcomes to the conventional HSD method. Nevertheless, further research with a larger sample size is needed.

Effect of the cone-beam CT acquisition trajectory on image quality in spine surgery: experimental cadaver study.

BACKGROUND: Intraoperative 3D imaging with cone-beam CT (CBCT) improves assessment of implant position and reduces complications in spine surgery. It is also used for image-guided surgical techniques, resulting in improved quality of care. However, in some cases, metal artifacts can reduce image quality and make it difficult to assess pedicle screw position and reduction. PURPOSE: The objective of this study was to investigate whether a change in CBCT acquisition trajectory in relation to pedicle screw position during dorsal instrumentation can reduce metal artifacts and consequently improve image quality and clinical assessability. STUDY DESIGN: Experimental cadaver study. METHODS: A human cadaver was instrumented with pedicle screws in the thoracic and lumbar spine region (Th11 to L5). Then, the acquisition trajectory of the CBCT (Cios Spin, Siemens, Germany) to the pedicle screws was systematically changed in 5° steps in angulation (-30° to +30°) and swivel (-25° to +25°). Subsequently, radiological evaluation was performed by 3 blinded, qualified raters on image quality using 9 questions (including anatomical structures, implant position, appearance of artifacts) with a score (1-5 points). For statistical evaluation, the image quality of the different acquisition trajectories was compared to the standard acquisition trajectory and checked for significant differences. RESULTS: The angulated acquisition trajectory significantly increased the score for subjective image quality (p<.001) as well as the clinical assessability of pedicle screw position (p<.001) with particularly strong effects on subjective image quality in the vertebral pedicle region (d=1.61). Swivel of the acquisition trajectory significantly improved all queried domains of subjective image quality (p<.001) as well as clinical assessability of pedicle screw position (p<.001). CONCLUSIONS: In this cadaver study, the angulation as well as the swivel of the acquisition trajectory led to a significantly improved image quality in intraoperative 3D imaging (CBCT) with a constant isocenter. The data show that maximizing the angulation/swivel angle towards 30°/25° provides the best tested subjective image quality and enhances clinical assessability. Therefore, a correct adjustment of the acquisition trajectory can help to make intraoperative revision decisions more reliably. CLINICAL SIGNIFICANCE: The knowledge of enhanced image quality by changing the acquisition trajectory in intraoperative 3D imaging can be used for the assessment of critical screw positions in spine surgery. The implementation of this knowledge requires only a minor change of the current intraoperative imaging workflow without additional technical equipment and could further reduce the need for revision surgery.

Comparison of accuracy, revision, and perioperative outcomes in robot-assisted spine surgeries: systematic review and meta-analysis.

OBJECTIVE: Pedicle screw placement guidance is critical in spinal fusions, and spinal surgery robots aim to improve accuracy and reduce complications. Current literature has yet to compare the relative merits of available robotic systems. In this review, the authors aimed to 1) assess the current state of spinal robotics literature; 2) conduct a meta-analysis of robotic performance based on accuracy, speed, and safety; and 3) offer recommendations for robotic system selection. METHODS: Following PRISMA guidelines, the authors conducted a systematic literature review across PubMed, Embase, Cochrane Library, Web of Science, and Scopus as of April 28, 2022, for studies on approved robots for placing lumbar pedicle screws. Three reviewers screened and extracted data relating to the study characteristics, accuracy rate, intraoperative revisions, and reoperations. Secondary performance metrics included operative time, blood loss, and radiation exposure. The authors statistically compared the performance of the robots using a random-effects model to account for variation within and between the studies. Each robot was also compared with performance benchmarks of traditional techniques including freehand, fluoroscopic, and CT-navigated insertion. Finally, we performed a Duval and Tweedie trim-and-fill test to assess for the presence of publication bias. RESULTS: The authors identified 46 studies, describing 4670 patients and 25,054 screws, that evaluated 4 different robotic systems: Mazor X, ROSA, ExcelsiusGPS, and Cirq. The weighted accuracy rates of Gertzbein-Robbins classification grade A or B screws were as follows: ExcelsiusGPS, 98.0%; ROSA, 98.0%; Mazor, 98.2%; and Cirq, 94.2%. No robot was significantly more accurate than the others. However, the accuracy of the ExcelsiusGPS was significantly higher than that of traditional methods, and the accuracies of the Mazor and ROSA were significantly higher than that of fluoroscopy. The intraoperative revision rates were Cirq, 0.55%; ROSA, 0.91%; Mazor, 0.98%; and ExcelsiusGPS, 1.08%. The reoperation rates were Cirq, 0.28%; ExcelsiusGPS, 0.32%; and Mazor, 0.76% (no reoperations were reported for ROSA). Operative times were similar for all robots. Both the ExcelsiusGPS and Mazor were associated with significantly less blood loss than the ROSA. The Cirq had the lowest radiation exposure. Robots tended to be more accurate and generally their use was associated with fewer reoperations and less blood loss than freehand, fluoroscopic, or CT-navigated techniques. CONCLUSIONS: Robotic platforms perform comparably based on key metrics, with high accuracy rates and low intraoperative revision and reoperation rates. The spinal robotics publication rate will continue to accelerate, and choosing a robot will depend on the context of the practice.

Design, fabrication, and evaluation of single- and multi-level 3D-printed non-covering cervical spinal fusion surgery templates.

Background: Cervical spinal fusion surgeries require accurate placement of the pedicle screws. Any misplacement/misalignment of these screws may lead to injuries to the spinal cord, arteries and other organs. Template guides have emerged as accurate and cost-effective tools for the safe and rapid insertions of pedicle screws. Questions/Purposes: Novel patient-specific single- and multi-level non-covering templates for cervical pedicle screw insertions were designed, 3D-printed, and evaluated. Methods: CT scans of two patients were acquired to reconstruct their 3D spine model. Two sets of single-level (C3-C7) and multi-level (C4-C6) templates were designed and 3D-printed. Pedicle screws were inserted into the 3D-printed vertebrae by free-hand and guided techniques. For single-level templates, a total of 40 screws (2 patients × 5 vertebrae × 2 methods × 2 screws) and for multi-level templates 24 screws (2 patients × 3 vertebrae × 2 methods × 2 screws) were inserted by an experienced surgeon. Postoperative CT images were acquired to measure the errors of the entry point, 3D angle, as well as axial and sagittal plane angles of the inserted screws as compared to the initial pre-surgery designs. Accuracy of free-hand and guided screw insertions, as well as those of the single- and multi-level guides, were also compared using paired t-tests. Results: Despite the minimal removal of soft tissues, the 3D-printed templates had acceptable stability on the vertebrae during drillings and their utilization led to statistically significant reductions in all error variables. The mean error of entry point decreased from 3.02 mm (free-hand) to 0.29 mm (guided) using the single-level templates and from 5.7 mm to 0.76 mm using the multi-level templates. The percentage reduction in mean of other error variables for, respectively, single- and multi-level templates were as follows: axial plane angle: 72% and 87%, sagittal plane angle: 56% and 78%, and 3D angle: 67% and 83%. The error variables for the multi-level templates generally exceeded those of the single-level templates. The use of single- and multi-level templates also considerably reduced the duration of pedicle screw placements. Conclusion: The novel single- and multi-level non-covering templates are valuable tools for the accurate placement of cervical pedicle screws.

Consistent anatomical relationships of pedicle, lamina, and superior articulating process in severe idiopathic scoliosis allow for safe freehand pedicle screw placement: A proof-of-concept technical study.

Introduction: Transpedicular screw placement has superior pullout strength compared to alternative forms of spinal fusion and is often performed in deformity correction surgery with navigation for optimal accuracy and reliability. Freehand technique for pedicle screws minimizes operation time and radiation exposure without fluoroscopy but is not widely adopted given the challenge of difficult anatomical corridors and accurate placement, especially in idiopathic scoliosis and advanced deformity. We used a computer-generated model to assess a proof-of-concept and anatomical feasibility of a freehand screw technique in severe scoliosis. Methods: Three-dimensional (3D) reconstructions of vertebra from a sample of two male patients with severe idiopathic scoliosis deformity (1 thoracic and 1 lumbar) with Cobb angles of 100° were used for planned placement of 17 levels of thoracolumbar (6.5 mm × 45 mm) pedicle screws. 3D reconstruction of each vertebra was created and measurements of screw entries and trajectories were reproduced with a 3D slicer software image computing platform. Results: Accurate transpedicular screw placement is possible with anatomical landmarks based on the 3D reconstructed vertebral levels. A series of 5 figures were assembled to demonstrate sagittal, coronal, and axial planes and key anatomical landmarks and trajectories of thoracic and lumbar freehand pedicle screws in severe idiopathic scoliosis. Conclusions: Anatomical landmarks for freehand transpedicular screw placement (between pedicle, lamina, and superior articulating process) are constant and reliable in severe idiopathic scoliosis as evidenced by 3D computer modeling. Preoperative computed tomography modeling may assist appropriate screw entry and trajectory based on anatomical landmarks for spine surgeons, and guide freehand technique for screw placement in adolescent idiopathic scoliosis.

3D Printed Pedicle Screws with Microarc Oxidation Ceramic Interfaces Enhance Osteointegration and Orthopedic Fixation Feasibility.

Effective osteointegration is of great importance for pedicle screws in spinal fusion surgeries. However, the lack of osteoinductive activity of current screws diminishes their feasibility for osteointegration and fixation, making screw loosening a common complication worldwide. In this study, Ti-6Al-4V pedicle screws with full through-hole design were fabricated via selective laser melting (SLM) 3D printing and then deposited with porous oxide coatings by microarc oxidation (MAO). The porous surface morphology of the oxide coating and the release of bioactive ions could effectively support cell adhesion, migration, vascularization, and osteogenesis in vitro. Furthermore, an in vivo goat model demonstrated the efficacy of modified screws in improving bone maturation and osseointegration, thus providing a promising method for feasible orthopedic internal fixation.

Pedicle screw insertion into infected vertebrae reduces operative time and range of fixation in minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis: a multicenter retrospective cohort study.

BACKGROUND: Minimally invasive posterior fixation surgery for pyogenic spondylitis is known to reduce invasiveness and complication rates; however, the outcomes of concomitant insertion of pedicle screws (PS) into the infected vertebrae via the posterior approach are undetermined. This study aimed to assess the safety and efficacy of PS insertion into infected vertebrae in minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis. METHODS: This multicenter retrospective cohort study included 70 patients undergoing minimally invasive posterior fixation for thoracolumbar pyogenic spondylitis across nine institutions. Patients were categorized into insertion and skip groups based on PS insertion into infected vertebrae, and surgical data and postoperative outcomes, particularly unplanned reoperations due to complications, were compared. RESULTS: The mean age of the 70 patients was 72.8 years. The insertion group (n = 36) had shorter operative times (146 versus 195 min, p = 0.032) and a reduced range of fixation (5.4 versus 6.9 vertebrae, p = 0.0009) compared to the skip group (n = 34). Unplanned reoperations occurred in 24% (n = 17) due to surgical site infections (SSI) or implant failure; the incidence was comparable between the groups. Poor infection control necessitating additional anterior surgery was reported in four patients in the skip group. CONCLUSIONS: PS insertion into infected vertebrae during minimally invasive posterior fixation reduces the operative time and range of fixation without increasing the occurrence of unplanned reoperations due to SSI or implant failure. Judicious PS insertion in patients with minimal bone destruction in thoracolumbar pyogenic spondylitis can minimize surgical invasiveness.

[Percutaneous pedicle screw anchored vertebral augmentation for the treatment of Kümmell disease without neurological symptoms].

OBJECTIVE: To explore the clinical effect of percutaneous pedicle screw anchored vertebral augmentation(PPSAVA) in the treatment of asymptomatic Kümmell disease without neurological symptoms. METHODS: The clinical data of 20 patients with Kümmell disease without neurological symptoms treated with PPSAVA in our hospital from January 2019 to December 2021 were analyzed retrospectively, including 5 males and 15 females, aged 56 to 88 (74.95±9.93) years old. and the course of disease was 7 to 60 days with an average of (21.35±14.46) days. All patients were treated with PPSAVA. The time of operation, the amount of bone cement injected and the leakage of bone cement were recorded. The visual analogue scale(VAS), Oswestry disability index(ODI), vertebral body angle(VBA), anterior edge height and midline height of vertebral body were compared among the before operation, 3 days after operation and during the final follow-up. The loosening and displacement of bone cement were observed during the final follow-up. RESULTS: All the 20 patients completed the operation successfully. The operation time was 30 to 56 min with an average of (41.15±7.65) min, and the amount of bone cement injection was 6.0 to 12.0 ml with an average of (9.30±1.49) ml. Bone cement leakage occurred in 6 cases and there were no obvious clinical symptoms. The follow-up time was 6 to 12 months with an average of (8.43±2.82) months. The VBA, anterior edge height and midline height of of injured vertebral body were significantly improved 3 days after operation and the final follow-up(P<0.05), and the VBA, anterior edge height and midline height of of injured vertebral body were lost in different degrees at the final follow-up (P<0.05). The VAS and ODI at 3 days after operation and at the final follow-up were significantly lower than those at preoperatively(P<0.05), but the VAS score and ODI at the final follow-up were not significantly different from those at 3 d after operation(P>0.05). At the last follow-up, no patients showed loosening or displacement of bone cement. CONCLUSION: PPSAVA is highly effective in treating Kümmell disease without neurological symptoms, improving patients' pain and functional impairment, and reducing the risk of cement loosening and displacement postoperatively.

Comparative Analysis of Monoaxial and Polyaxial Pedicle Screws in the Surgical Correction of Adolescent Idiopathic Scoliosis.

Background: Although several biomechanical studies have been reported, few clinical studies have compared the efficacy of monoaxial and polyaxial pedicle screws in the surgical treatment of adolescent idiopathic scoliosis (AIS). This study aims to compare the radiological and clinical outcomes of mono- and polyaxial pedicle screws in the surgical treatment of AIS. Methods: A total of 46 AIS patients who underwent surgery to treat scoliosis using pedicle screw instrumentation (PSI) and rod derotation (RD) were divided into two groups according to the use of pedicle screws: the monoaxial group (n = 23) and polyaxial group (n = 23). Results: The correction rate of the main Cobb's angle was higher in the monoaxial group (70.2%) than in the polyaxial group (65.3%) (p = 0.040). No differences in the rotational correction of the apical vertebra were evident between the two groups. SRS-22 scores showed no significant differences according to the type of pedicle screws used. Conclusions: The use of polyaxial pedicle screws resulted in coronal, sagittal, and rotational correction outcomes comparable to those associated with the use of monoaxial pedicle screws for surgical treatment using PSI and RD to treat moderate cases of AIS.