Robot-assisted percutaneous pedicle screw placement accuracy compared with alternative guidance in lateral single-position surgery

J Neurosurg Spine 39:443–451, 2023

While single-position surgery (SPS) eliminates the need for patient repositioning, the placement of screws in the unconventional lateral position poses unique challenges related to asymmetry relative to the surgical table. Use of robotic guidance or intraoperative navigation can help to overcome this. The aim of this study was to compare the relative accuracies offered by these various navigation modalities for pedicle screws placed in lateral SPS.

METHODS According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the PubMed/Medline, Embase, and Cochrane Library databases were queried for studies reporting pedicle screw placement accuracy using fluoroscopic, CT-navigated, O-arm, or robotic guidance in lateral SPS, and a systematic review and meta-analysis was performed. Included studies all compared evaluated screw placement accuracy in lateral SPS using a single navigation method. Quality assessment was performed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system; risk of bias was assessed using the Newcastle-Ottawa Scale and the Joanna Briggs Institute checklist. The primary outcome, rate of pedicle screw breach, was analyzed using random-effects meta-analysis.

RESULTS Eleven studies were included comprising 548 patients who underwent the placement of instrumentation with 2488 screws. For the fluoroscopic, CT-navigated, O-arm, and robotic guidance cohorts, there were 3, 2, 3, and 3 studies, respectively. Breach rates by modality were as follows: fluoroscopic guidance (6.6%), CT navigation (4.7%), O-arm (3.9%), and robotic guidance (3.9%). Random-effects meta-analysis showed a significant difference between studies, with an overall breach rate of 4.9% (95% CI 3.1%–7.5%; p < 0.001); however, testing for subgroup differences failed to show a significant difference between guidance modalities (Q M = 0.69, df = 3; p = 0.88). Heterogeneity between studies was significant (I 2 = 79.0%, τ 2 = 0.41, χ 2 = 47.65, df = 10; p < 0.001).

CONCLUSIONS Robotic guidance of screws is noninferior to alternative guidance modalities in lateral SPS; however, additional prospective studies directly comparing different guidance types are merited.

Retrospective single-surgeon study of prone versus lateral robotic pedicle screw placement: a CT-based assessment of accuracy

J Neurosurg Spine 39:490–497, 2023

Lateral lumbar interbody fusion including anterior-to-psoas oblique lumbar interbody fusion has conventionally relied on pedicle screw placement (PSP) for construct stabilization. Single-position surgery with lumbar interbody fusion in the lateral decubitus position with concomitant PSP has been associated with increased operative efficiency. What remains unclear is the accuracy of PSP with robotic guidance when compared with the more familiar prone patient positioning. The present study aimed to compare robot-assisted screw placement accuracy between patients with instrumentation placed in the prone and lateral positions.

METHODS The authors identified all consecutive patients treated with interbody fusion and PSP in the prone or lateral position by a single surgeon between January 2019 and October 2022. All pedicle screws placed were analyzed using CT scans to determine appropriate positioning according to the Gertzbein-Robbins classification grading system (grade C or worse was considered as a radiographically significant breach). Multivariate logistic regression models were constructed to identify risk factors for the occurrence of a radiographically significant breach.

RESULTS Eighty-nine consecutive patients (690 screws) were included, of whom 46 (477 screws) were treated in the prone position and 43 (213 screws) in the lateral decubitus position. There were fewer breaches in the prone (n = 13, 2.7%) than the lateral decubitus (n = 15, 7.0%) group (p = 0.012). Nine (1.9%) radiographically significant breaches occurred in the prone group compared with 10 (4.7%) in the lateral decubitus group (p = 0.019), for a prone versus lateral decubitus PSP accuracy rate of 98.1% versus 95.3%. There were no significant differences in BMI between prone versus lateral decubitus cohorts (30.1 vs 29.6) or patients with screw breach versus those without (31.2 vs 29.5). In multivariate models, the prone position was the only significant protective factor for screw accuracy; no other significant risk factors for screw breach were identified.

CONCLUSIONS The present data suggest that pedicle screws placed with robotic assistance have higher placement accuracy in the prone position. Further studies will be needed to validate the accuracy of PSP in the lateral position as single-position surgery becomes more commonplace in the treatment of spinal disorders.

Robot‑assisted endoscopic third ventriculostomy under intraoperative CT imaging guidance

Acta Neurochirurgica (2023) 165:2525–2531

The robot-assisted neurosurgical procedures have recently benefited of the evolution of intraoperative imaging, including mobile CT unit available in the operating room. This facilitated use paved the way to perform more neurosurgical procedures under robotic assistance. Endoscopic third ventriculocisternostomy requires both a safe transcortical trajectory and a smooth manipulation.

Method We describe our technique of robot-assisted endoscopic third ventriculocisternostomy combining robotic assistance and intraoperative CT imaging.

Conclusion Robot-assisted endoscopic third ventriculocisternostomy using modern intraoperative neuroimaging can be easily implemented and prevented erroneous trajectory and abrupt endoscopic movements, reducing surgically induced brain damages.

Robotic Instruments Inside the MRI Bore: Key Concepts and Evolving Paradigms in Imaging-enhanced Cranial Neurosurgery

World Neurosurg. (2023) 176:127-139

Intraoperative MRI has been increasingly used to robotically deliver electrodes and catheters into the human brain using a linear trajectory with great clinical success.

Current cranial MR guided robotics do not allow for continuous realtime imaging during the procedure because most surgical instruments are not MR-conditional. MRI guided robotic cranial surgery can achieve its full potential if all the traditional advantages of robotics (such as tremor-filtering, precision motion scaling, etc.) can be incorporated with the neurosurgeon physically present in the MRI bore or working remotely through controlled robotic arms.

The technological limitations of design optimization, choice of sensing, kinematic modeling, physical constraints, and real-time control had hampered early developments in this emerging field, but continued research and development in these areas over time has granted neurosurgeons far greater confidence in using cranial robotic techniques.

This article elucidates the role of MR-guided robotic procedures using clinical devices like NeuroBlate and Clearpoint that have several thousands of cases operated in a “linear cranial trajectory” and planned clinical trials, such as LAANTERN for MR guided robotics in cranial neurosurgery using LITT and MR-guided putaminal delivery of AAV2 GDNF in Parkinson’s disease. The next logical improvisation would be a steerable curvilinear trajectory in cranial robotics with added DOFs and distal tip dexterity to the neurosurgical tools. Similarly, the novel concept of robotic actuators that are powered, imaged, and controlled by the MRI itself is discussed in this article, with its potential for seamless cranial neurosurgery.

Feasibility and Accuracy of Robot-Assisted, Stereotactic Biopsy Using 3-Dimensional Intraoperative Imaging and Frameless Registration Tool

Neurosurgery 92:803–811, 2023

Robot-assisted stereotactic biopsy is evolving: 3-dimensional intraoperative imaging tools and new frameless registration systems are spreading.

OBJECTIVE: To investigate the accuracy and effectiveness of a new stereotactic biopsy procedure.

METHODS: Observational, retrospective analysis of consecutive robot-assisted stereotactic biopsies using the Neurolocate (Renishaw) frameless registration system and intraoperative O-Arm (Medtronic) performed at a single institution in adults (2019-2021) and comparisonwith a historical series from the same institution (2006-2016) not using the Neurolocate nor the O-Arm.

RESULTS: In 100 patients (55%men), 6.2 ± 2.5 (1-14) biopsy sampleswere obtained at 1.7 ± 0.7 (1-3) biopsy sites. An histomolecular diagnosis was obtained in 96% of cases. The mean duration of the procedure was 59.0 ± 22.3 min. Themean distance between the planned and the actual target was 0.7 ± 0.7 mm. On systematic postoperative computed tomography scans, a hemorrhage ≥10 mm was observed in 8 cases (8%) while pneumocephalus was distant from the biopsy site in 76%. A Karnofsky Performance Status score decrease ≥20 points postoperatively was observed in 4%. The average dose length product was 159.7 ± 63.4mGy cm. Compared with the historical neurosurgical procedure, this newprocedure had similar diagnostic yield (96 vs 98.7%; P = .111) and rate of postoperative disability (4.0 vs 4.2%, P = .914) but was shorter (57.8 ± 22.9 vs 77.8 ± 20.9 min; P < .001) despite older patients.

CONCLUSION: Robot-assisted stereotactic biopsy using the Neurolocate frameless registration system and intraoperative O-Arm is a safe and effective neurosurgical procedure. The accuracy of this robot-assisted surgery supports its effectiveness for daily use in stereotactic neurosurgery.

A Retrospective Analysis of Pedicle Screw Placement Accuracy Using the ExcelsiusGPS Robotic Guidance System

Operative Neurosurgery 24:242–247, 2023

Robotic guidance has become widespread in spine surgery. Although the intent is improved screw placement, further system-specific data are required to substantiate this intention for pedicle screws in spinal stabilization constructs.

OBJECTIVE: To determine the accuracy of pedicle screws placed with the aid of a robot in a cohort of patients immediately after the adoption of the robot-assisted surgery technique.

METHODS: A retrospective, Institutional Review Board–approved study was performed on the first 100 patients at a single facility, who had undergone spinal surgeries with the use of robotic techniques. Pedicle screw accuracy was graded using the Gertzbein– Robbins Scale based on pedicle wall breach, with grade A representing 0 mm breach and successive grades increasing breach thresholds by 2 mm increments. Preoperative and postoperative computed tomography scans were also used to assess offsets between the objective plan and true screw placements.

RESULTS: A total of 326 screws were analyzed among 72 patients with sufficient imaging data. Ages ranged from 21 to 84 years. The total accuracy rate based on the Gertzbein– Robbins Scale was 97.5%, and the rate for each grade is as follows: A, 82%; B, 15.5%; C, 1.5%; D, 1%; and E, 0. The average tip offset was 1.9 mm, the average tail offset was 2.0 mm, and the average angular offset was 2.6°.

CONCLUSION: Robotic-assisted surgery allowed for accurate implantation of pedicle screws on immediate adoption of this technique. There were no complications attributable to the robotic technique, and no hardware revisions were required.

Robot-assisted and augmented reality–assisted spinal instrumentation

J Neurosurg Spine 37:299–314, 2022

The use of technology-enhanced methods in spine surgery has increased immensely over the past decade. Here, the authors present the largest systematic review and meta-analysis to date that specifically addresses patient-centered outcomes, including the risk of inaccurate screw placement and perioperative outcomes in spinal surgeries using robotic instrumentation and/or augmented reality surgical navigation (ARSN).

METHODS A systematic review of the literature in the PubMed, EMBASE, Web of Science, and Cochrane Library databases spanning the last decade (January 2011–November 2021) was performed to present all clinical studies comparing robot-assisted instrumentation and ARSN with conventional instrumentation techniques in lumbar spine surgery. The authors compared these two technologies as they relate to screw accuracy, estimated blood loss (EBL), intraoperative time, length of stay (LOS), perioperative complications, radiation dose and time, and the rate of reoperation.

RESULTS A total of 64 studies were analyzed that included 11,113 patients receiving 20,547 screws. Robot-assisted instrumentation was associated with less risk of inaccurate screw placement (p < 0.0001) regardless of control arm approach (freehand, fluoroscopy guided, or navigation guided), fewer reoperations (p < 0.0001), fewer perioperative complications (p < 0.0001), lower EBL (p = 0.0005), decreased LOS (p < 0.0001), and increased intraoperative time (p = 0.0003). ARSN was associated with decreased radiation exposure compared with robotic instrumentation (p = 0.0091) and fluoroscopy-guided (p < 0.0001) techniques.

CONCLUSIONS Altogether, the pooled data suggest that technology-enhanced thoracolumbar instrumentation is advantageous for both patients and surgeons. As the technology progresses and indications expand, it remains essential to continue investigations of both robotic instrumentation and ARSN to validate meaningful benefit over conventional instrumentation techniques in spine surgery.

Systematic review registration no.: CRD42021283631 (https://www.crd.york.ac.uk/prospero/)

Lateral versus prone robot-assisted percutaneous pedicle screw placement: a CT-based comparative assessment of accuracy

J Neurosurg Spine 37:112–120, 2022

Single-position lateral lumbar interbody fusion (SP-LLIF) has recently gained significant popularity due to increased operative efficiency, but it remains technically challenging. Robot-assisted percutaneous pedicle screw (RAPPS) placement can facilitate screw placement in the lateral position. The authors have reported their initial experience with SP-LLIF with RA-PPS placement in the lateral position, and they have compared this accuracy with that of RA-PPS placement in the prone position.

METHODS The authors reviewed prospectively collected data from their first 100 lateral-position RA-PPSs. The authors graded screw accuracy on CT and compared it to the accuracy of all prone-position RA-PPS procedures during the same time period. The authors analyzed the effect of several demographic and perioperative metrics, as a whole and specifically for lateral-position RA-PPS placement.

RESULTS The authors placed 99 lateral-position RA-PPSs by using the ExcelsiusGPS robotic platform in the first 18 consecutive patients who underwent SP-LLIF with postoperative CT imaging; these patients were compared with 346 prone-position RA-PPSs that were placed in the first consecutive 64 patients during the same time period. All screws were placed at L1 to S1. Overall, the lateral group had 14 breaches (14.1%) and the prone group had 25 breaches (7.2%) (p = 0.032). The lateral group had 5 breaches (5.1%) greater than 2 mm (grade C or worse), and the prone group had 4 (1.2%) (p = 0.015). The operative level had an effect on the breach rate, with breach rates (grade C or worse) of 7.1% at L3 and 2.8% at L4. Most breaches were grade B (< 2 mm) and lateral, and no breach had clinical sequelae or required revision. Within the lateral group, multivariate regression analysis demonstrated that BMI and number of levels affected accuracy, but the side that was positioned up or down did not.

CONCLUSIONS RA-PPSs can improve the feasibility of SP-LLIF. Spine surgeons should be cautious and selective with this technique owing to decreased accuracy in the lateral position, particularly in obese patients. Further studies should compare SP-LLIF techniques performed while the patient is in the prone and lateral positions.

Ninety-day complication, revision, and readmission rates for current-generation robot-assisted thoracolumbar spinal fusion surgery

J Neurosurg Spine 36:841–848, 2022

Robotics is a major area for research and development in spine surgery. The high accuracy of robot-assisted placement of thoracolumbar pedicle screws is documented in the literature. The authors present the largest case series to date evaluating 90-day complication, revision, and readmission rates for robot-assisted spine surgery using the current generation of robotic guidance systems.

METHODS An analysis of a retrospective, multicenter database of open and minimally invasive thoracolumbar instrumented fusion surgeries using the Mazor X or Mazor X Stealth Edition robotic guidance systems was performed. Patients 18 years of age or older and undergoing primary or revision surgery for degenerative spinal conditions were included. Descriptive statistics were used to calculate rates of malpositioned screws requiring revision, as well as overall complication, revision, and readmission rates within 90 days.

RESULTS In total, 799 surgical cases (Mazor X: 48.81%; Mazor X Stealth Edition: 51.19%) were evaluated, involving robot-assisted placement of 4838 pedicle screws. The overall intraoperative complication rate was 3.13%. No intraoperative implant-related complications were encountered. Postoperatively, 129 patients suffered a total of 146 complications by 90 days, representing an incidence of 16.1%. The rate of an unrecognized malpositioned screw resulting in a new postoperative radiculopathy requiring revision surgery was 0.63% (5 cases). Medical and pain-related complications unrelated to hardware placement accounted for the bulk of postoperative complications within 90 days. The overall surgical revision rate at 90 days was 6.63% with 7 implant-related revisions, representing an implant-related revision rate of 0.88%. The 90-day readmission rate was 7.13% with 2 implant-related readmissions, representing an implant-related readmission rate of 0.25% of cases.

CONCLUSIONS The results of this multicenter case series and literature review suggest current-generation robotic guidance systems are associated with low rates of intraoperative and postoperative implant-related complications, revisions, and readmissions at 90 days. Future outcomes-based studies are necessary to evaluate complication, revision, and readmission rates compared to conventional surgery.

 

Robotic-Assisted vs Nonrobotic-Assisted Minimally Invasive Transforaminal Lumbar Interbody Fusion: A Cost-Utility Analysis

Neurosurgery 90:192–198, 2022

Management of degenerative disease of the spine has evolved to favor minimally invasive techniques, including nonrobotic-assisted and robotic-assisted minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Value-based spending is being increasingly implemented to control rising costs in the US healthcare system. With an aging population, it is fundamental to understand which procedure(s) may be most cost-effective.

OBJECTIVE: To compare robotic and nonrobotic MIS-TLIF through a cost-utility analysis.

METHODS: We considered direct medical costs related to surgical intervention and to the hospital stay, as well as 1-yr utilities. We estimated costs by assessing all cases involving adults undergoing robotic surgery at a single institution and an equal number of patients undergoing nonrobotic surgery, matched by demographic and clinical characteristics. We adopted a willingness to pay of $50 000/quality-adjusted life year (QALY). Uncertainty was addressed by deterministic and probabilistic sensitivity analyses.

RESULTS: Costs were estimated based on a total of 76 patients, including 38 undergoing robot-assisted and 38 matched patients undergoing nonrobot MIS-TLIF. Using point estimates, robotic surgery was projected to cost $21 546.80 and to be associated with 0.68 QALY, and nonrobotic surgery was projected to cost $22 398.98 and to be associated with 0.67 QALY. Robotic surgery was found to be more cost-effective strategy, with costeffectiveness being sensitive operating room/materials and room costs. Probabilistic sensitivity analysis identified robotic surgery as cost-effective in 63% of simulations.

CONCLUSION: Our results suggest that at a willingness to pay of $50 000/QALY, robotic assisted MIS-TLIF was cost-effective in 63% of simulations. Cost-effectiveness depends on operating room and room (admission) costs, with potentially different results under distinct neurosurgical practices.

Collaborative spinal robot system for laminectomy: a preliminary study

Neurosurg Focus 52 (1):E11, 2022

The application of robots in the field of pedicle screw placement has achieved great success. However, decompressive laminectomy, a step that is just as critical as pedicle screw placement, does not have a mature robot-assisted system. To address this lack, the authors designed a collaborative spine robot system to assist with laminectomy. In this study, they aimed to investigate the reliability of this novel collaborative spinal robot system and compare it with manual laminectomy (ML).

METHODS Thirty in vitro porcine lumbar vertebral specimens were obtained as experimental bone specimens. Robot-assisted laminectomy (RAL) was performed on the left side of the lamina (n = 30) and ML was performed on the right side (n = 30). The time required for laminectomy on one side, whether the lamina was penetrated, and the remaining thickness of the lamina were compared between the two groups.

RESULTS The time required for laminectomy on one side was longer in the RAL group than in the ML group (median 326 seconds [IQR 133 seconds] vs 108.5 seconds [IQR 43 seconds], p < 0.001). In the RAL group, complete lamina penetration occurred twice (6.7%), while in the ML group, it occurred 9 times (30%); the difference was statistically significant (p = 0.045). There was no statistically significant difference in the remaining lamina thickness between the two groups (median 1.035 mm [IQR 0.419 mm] vs 1.084 mm [IQR 0.383 mm], p = 0.842).

CONCLUSIONS The results of this study confirm the safety of this novel spinal robot system for laminectomy. However, its efficiency requires further improvement.

Three-dimensional assessment of robot-assisted pedicle screw placement accuracy and instrumentation reliability based on a preplanned trajectory

J Neurosurg Spine 33:519–528, 2020

Robotic spine surgery systems are increasingly used in the US market. As this technology gains traction, however, it is necessary to identify mechanisms that assess its effectiveness and allow for its continued improvement. One such mechanism is the development of a new 3D grading system that can serve as the foundation for error-based learning in robot systems. Herein the authors attempted 1) to define a system of providing accuracy data along all three pedicle screw placement axes, that is, cephalocaudal, mediolateral, and screw long axes; and 2) to use the grading system to evaluate the mean accuracy of thoracolumbar pedicle screws placed using a single commercially available robotic system.

METHODS The authors retrospectively reviewed a prospectively maintained, IRB-approved database of patients at a single tertiary care center who had undergone instrumented fusion of the thoracic or lumbosacral spine using robotic assistance. Patients with preoperatively planned screw trajectories and postoperative CT studies were included in the final analysis. Screw accuracy was measured as the net deviation of the planned trajectory from the actual screw trajectory in the mediolateral, cephalocaudal, and screw long axes.

RESULTS The authors identified 47 patients, 51% male, whose pedicles had been instrumented with a total of 254 screws (63 thoracic, 191 lumbosacral). The patients had a mean age of 61.1 years and a mean BMI of 30.0 kg/m2. The mean screw tip accuracies were 1.3 ± 1.3 mm, 1.2 ± 1.1 mm, and 2.6 ± 2.2 mm in the mediolateral, cephalocaudal, and screw long axes, respectively, for a net linear deviation of 3.6 ± 2.3 mm and net angular deviation of 3.6° ± 2.8°. According to the Gertzbein-Robbins grading system, 184 screws (72%) were classified as grade A and 70 screws (28%) as grade B. Placement of 100% of the screws was clinically acceptable.

CONCLUSIONS The accuracy of the discussed robotic spine system is similar to that described for other surgical systems. Additionally, the authors outline a new method of grading screw placement accuracy that measures deviation in all three relevant axes. This grading system could provide the error signal necessary for unsupervised machine learning by robotic systems, which would in turn support continued improvement in instrumentation placement accuracy.

 

Laser Ablation of Abnormal Neurological Tissue Using Robotic Neuroblate System (LAANTERN)

Neurosurgery 86:538–547, 2020

Stereotactic laser ablation (SLA) has demonstrated potential utility for a spectrum of difficult to treat neurosurgical pathologies in multiple small and/or retrospective single-institutional series. Here, we present the safety profile of SLA of intracranial lesions from the Laser Ablation of Abnormal Neurological Tissue using Robotic NeuroBlate System (LAANTERN; Monteris Medical) multi-institutional, international prospective observational registry.

OBJECTIVE: To determine the procedural safety of SLA for intracranial lesions.

METHODS: Prospective procedural safety and hospitalization data from the first 100 treated LAANTERN patients was collected and analyzed.

RESULTS: Mean age and baseline Karnofsky Performance Status (KPS) were 51(±17) yr and 83(± 15), respectively. In total, 81.2% of patients had undergone prior surgical or radiation treatment. Most patients had a single lesion (79%) ablated through 1 burr hole (1.2±0.7 per patient), immediately following a lesion biopsy. In total, >90% of the lesion was ablated in 72% of treated lesions. Average total procedural time was 188.2 ± 69.6 min, and average blood loss was 17.7 ± 55.6 ccs. The average length of intensive care unit (ICU) and hospital stays before discharge were 38.1 ± 62.7 h and 61.1 ± 87.2 h, respectively. There were 5 adverse events (AEs) attributable to SLA (5/100; 5%). After the procedure, 84.8% of patients were discharged home. There was 1 mortality within 30 d of the procedure (1/100; 1%), which was not attributable to SLA.

CONCLUSION: SLA is a safe, minimally invasive procedure with favorable postprocedural ICU and hospital utilization profiles.

A novel robot-guided minimally invasive technique for brain tumor biopsies

J Neurosurg 132:150–158, 2020

As decisions regarding tumor diagnosis and subsequent treatment are increasingly based on molecular pathology, the frequency of brain biopsies is increasing. Robotic devices overcome limitations of frame-based and frameless techniques in terms of accuracy and usability. The aim of the present study was to present a novel, minimally invasive, robot-guided biopsy technique and compare the results with those of standard burr hole biopsy.

METHODS A tubular minimally invasive instrument set was custom-designed for the iSYS-1 robot-guided biopsies. Feasibility, accuracy, duration, and outcome were compared in a consecutive series of 66 cases of robot-guided stereotactic biopsies between the minimally invasive (32 patients) and standard (34 patients) procedures.

RESULTS Application of the minimally invasive instrument set was feasible in all patients. Compared with the standard burr hole technique, accuracy was significantly higher both at entry (median 1.5 mm [range 0.2–3.2 mm] vs 1.7 mm [range 0.8–5.1 mm], p = 0.008) and at target (median 1.5 mm [range 0.4–3.4 mm] vs 2.0 mm [range 0.8–3.9 mm], p = 0.019). The incision-to-suture time was significantly shorter (median 30 minutes [range 15–50 minutes] vs 37.5 minutes [range 25–105 minutes], p < 0.001). The skin incision was significantly shorter (median 16.3 mm [range 12.7–23.4 mm] vs 28.4 mm [range 20–42.2 mm], p = 0.002). A diagnostic tissue sample was obtained in all cases.

CONCLUSIONS Application of the novel instrument set was feasible in all patients. According to the authors’ data, the minimally invasive robot-guidance procedure can significantly improve accuracy, reduce operating time, and improve the cosmetic result of stereotactic biopsies.

Safety and accuracy of robot-assisted versus fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery

J Neurosurg Spine 30:615–622, 2019

The object of this study was to compare the safety and accuracy of pedicle screw placement using the TiRobot system versus conventional fluoroscopy in thoracolumbar spinal surgery.

METHODS Patients with degenerative or traumatic thoracolumbar spinal disorders requiring spinal instrumentation were randomly assigned to either the TiRobot-assisted group (RG) or the freehand fluoroscopy-assisted group (FG) at a 1:1 ratio. The primary outcome measure was the accuracy of screw placement according to the Gertzbein-Robbins scale; grades A and B (pedicle breach < 2 mm) were considered clinically acceptable. In the RG, discrepancies between the planned and actual screw placements were measured by merging postoperative CT images with the trajectory planning images. Secondary outcome parameters included proximal facet joint violation, duration of surgery, intraoperative blood loss, conversion to freehand approach in the RG, postoperative hospital stay, and radiation exposure.

RESULTS A total of 1116 pedicle screws were implanted in 234 patients (119 in the FG, and 115 in the RG). In the RG, 95.3% of the screws were perfectly positioned (grade A); the remaining screws were graded B (3.4%), C (0.9%), and D (0.4%). In the FG, 86.1% screws were perfectly positioned (grade A); the remaining screws were graded B (7.4%), C (4.6%), D (1.4%), and E (0.5%). The proportion of clinically acceptable screws was significantly greater in the RG than in the FG (p < 0.01). In the RG, the mean deviation was 1.5 ± 0.8 mm for each screw. The most common direction of screw deviation was lateral in the RG and medial in the FG. Two misplaced screws in the FG required revision surgery, whereas no revision was required in the RG. None of the screws in the RG violated the proximal facet joint, whereas 12 screws (2.1%) in the FG violated the proximal facet joint (p < 0.01). The RG had significantly less blood loss (186.0 ± 255.3 ml) than the FG (217.0 ± 174.3 ml; p < 0.05). There were no significant differences between the two groups in terms of surgical time and postoperative hospital stay. The mean cumulative radiation time was 81.5 ± 38.6 seconds in the RG and 71.5 ± 44.2 seconds in the FG (p = 0.07). Surgeon radiation exposure was significantly less in the RG (21.7 ± 11.5 μSv) than in the FG (70.5 ± 42.0 μSv; p < 0.01).

CONCLUSIONS TiRobot-guided pedicle screw placement is safe and useful in thoracolumbar spinal surgery. Clinical trial registration no.: NCT02890043 (clinicaltrials.gov)

 

Pedicle Screw Placement Using Augmented Reality Surgical Navigation With Intraoperative 3D Imaging

Spine 2019;44:517–525

The aim of this study was to evaluate the accuracy of pedicle screw placement using augmented reality surgical navigation (ARSN) in a clinical trial.

Summary of Background Data. Recent cadaveric studies have shown improved accuracy for pedicle screw placement in the thoracic spine using ARSN with intraoperative 3D imaging, without the need for periprocedural x-ray. In this clinical study, we used the same system to place pedicle screws in the thoracic and lumbosacral spine of 20 patients.

Methods. The study was performed in a hybrid operating room with an integrated ARSN system encompassing a surgical table, a motorized flat detector C-arm with intraoperative 2D/3D capabilities, integrated optical cameras for augmented reality navigation, and noninvasive patient motion tracking. Three independent reviewers assessed screw placement accuracy using the Gertzbein grading on 3D scans obtained before wound closure. In addition, the navigation time per screw placement was measured.

Results. One orthopedic spinal surgeon placed 253 lumbosacral and thoracic pedicle screws on 20 consenting patients scheduled for spinal fixation surgery. An overall accuracy of 94.1% of primarily thoracic pedicle screws was achieved. No screws were deemed severely misplaced (Gertzbein grade 3). Fifteen (5.9%) screws had 2 to 4mm breach (Gertzbein grade 2), occurring in scoliosis patients only. Thirteen of those 15 screws were larger than the pedicle in which they were placed. Two medial breaches were observed and 13 were lateral. Thirteen of the grade 2 breaches were in the thoracic spine. The average screw placement time was 5.24.1 minutes. During the study, no device-related adverse event occurred. Conclusion. ARSN can be clinically used to place thoracic and lumbosacral pedicle screws with high accuracy and with acceptable navigation time. Consequently, the risk for revision surgery and complications could be minimized. Key words: augmented reality, image-guided surgery, intraoperative 3D cone beam computed tomography imaging, pedicle screw accuracy, scoliosis.

Level of Evidence: 3

 

Robot-assisted stereoelectroencephalography in children

J Neurosurg Pediatr 23:288–296, 2019

The goal in the study was to describe the clinical outcomes associated with robot-assisted stereoelectroencephalography (SEEG) in children.

METHODS The authors performed a retrospective, single-center study in consecutive children with medically refractory epilepsy who were undergoing robot-assisted SEEG. Kaplan-Meier survival analysis was used to calculate the probability of seizure freedom. Both univariate and multivariate methods were used to analyze the preoperative and operative factors associated with seizure freedom.

RESULTS Fifty-seven children underwent a total of 64 robot-assisted procedures. The patients’ mean age was 12 years, an average of 6.4 antiepileptic drugs (AEDs) per patient had failed prior to implantation, and in 56% of the patients the disease was considered nonlesional. On average, children had 12.4 electrodes placed per implantation, with an implantation time of 9.6 minutes per electrode and a 10-day postoperative stay. SEEG analysis yielded a definable epileptogenic zone in 51 (89%) patients; 42 (74%) patients underwent surgery, half of whom were seizure free at last follow-up, 19.6 months from resection. In a multivariate generalized linear model, resective surgery, older age, and shorter SEEGrelated hospital length of stay were associated with seizure freedom. In a Cox proportional hazards model including only the children who underwent resective surgery, older age was the only significant factor associated with seizure freedom. Complications related to bleeding were the major contributors to morbidity. One patient (1.5%) had a symptomatic hemorrhage resulting in a permanent neurological deficit.

CONCLUSIONS The authors report one of the largest pediatric-specific SEEG series demonstrating that the modern surgical management of medically refractory epilepsy in children can lead to seizure freedom in many patients, while also highlighting the challenges posed by this difficult patient population.

 

Treating cerebrovascular diseases in hybrid operating room equipped with a robotic angiographic fluoroscopy system: level of necessity and 5-year experiences

Acta Neurochirurgica (2019) 161:611–619

A hybrid operating room (OR) equipped with robotic angiographic fluoroscopy system has become prevalent in neurosurgery. The level of necessity of the hybrid OR in treating cerebrovascular diseases (CVD) is rarely discussed.

Objective The authors proposed a scoring and classification system to evaluate the cerebrovascular procedures according to the level of treatment necessity for CVD in a hybrid OR and shared our 5-year experiences. Methods From December 2009 to January 2016, the registry of cerebrovascular procedures performed in the hybrid OR was retrieved. A scoring system was used to evaluate the importance of the surgical and interventional components of a cerebrovascular procedure performed in the hybrid OR. The score of either component ranged from 1, 1.5, to 2 (1 = no role, 1.5 = supplementary or informative, 2 = important or therapeutic). The total score of a procedure was by multiplying two individual scores. Levels of necessity were classified into level A (important), level B (beneficial), and level C (replaceable).

Results A total of 1027 cerebrovascular procedures were performed during this period: diagnostic angiography in 328, carotid artery stenting in 286, aneurysm coiling in 128, intra-operative DSA in 101, aspiration of ICH under image guidance in 79, intraarterial thrombolysis/thrombectomy in 51, intracranial angioplasty/stenting in 30, hybrid surgery/serial procedures in 19, and rescue surgery during embolization in 5. According to the scoring system, hybrid surgery and serial procedures scored the highest points (2 × 2). The percentages distributed at each level: levels A (2.3%), B (17.5%), and C (80.2%).

Conclusion This study conveys a concept of what a hybrid OR equipped with robotic angiographic fluoroscopy system is capable of and its potential. For cerebrovascular diseases, hybrid OR exerts its value via hybrid surgery or avoiding patient transportation in serial procedures (level A), via providing real-time high-quality angiography and image guidance (level B), which constituted about 20% of the cases. The subspecialty of the group using the hybrid OR directly reflects on the number of procedures categorized in each level. In a hybrid OR, innovative treatment strategies for difficult-to-treat CVD can be developed.

Robot-assisted intravertebral augmentation corrects local kyphosis more effectively than a conventional fluoroscopy-guided technique

J Neurosurg Spine 30:289–295, 2019

Intravertebral augmentation (IVA) is a reliable minimally invasive technique for treating Magerl type A vertebral body fractures. However, poor correction of kyphotic angulation, the risk of cement leakage, and significant exposure to radiation (for the surgeon, the operating room staff, and the patient) remain significant issues. The authors conducted a study to assess the value of robot-assisted IVA (RA-IVA) for thoracolumbar vertebral body fractures.

METHODS The authors performed a retrospective, single-center study of patients who had undergone RA-IVA or conventional fluoroscopy-guided IVA (F-IVA) for thoracolumbar vertebral body fractures. Installation and operating times, guidance accuracy, residual local kyphosis, degree of restoration of vertebral body height, incidence of cement leakage, rate of morbidity, length of hospital stay, and radiation-related data were recorded.

RESULTS Data obtained in 30 patients who underwent RA-IVA were compared with those obtained in 30 patients who underwent F-IVA during the same period (the surgical indications were identical, but the surgeons were different). The mean ± SD installation time in the RA-IVA group (24 ± 7.5 minutes) was significantly shorter (p = 0.005) than that in the F-IVA group (26 ± 8 minutes). The mean operating time for the RA-IVA group (52 ± 11 minutes) was significantly longer (p = 0.026) than that for the F-IVA group (30 ± 11 minutes). All RA-IVAs and F-IVAs were Ravi’s scale grade A (no pedicle breach). The mean degree of residual local kyphosis (4.7° ± 3.15°) and the percentage of vertebral body height restoration (63.6% ± 21.4%) were significantly better after RA-IVA than after F-IVA (8.4° ± 5.4° and 30% ± 34%, respectively). The incidence of cement leakage was significantly lower in the RA-IVA group (p < 0.05). The mean length of hospital stay after surgery was 3.2 days for both groups. No surgery-related complications occurred in either group. With RA-IVA, the mean radiation exposure was 438 ± 147 mGy × cm for the patient and 30 ± 17 mGy for the surgeon.

CONCLUSIONS RA-IVA provided better vertebral body fracture correction than the conventional F-IVA. However, RAIVA requires more time than F-IVA.

 

Robot-assisted multi-level anterior lumbar interbody fusion: an anatomical study

Acta Neurochirurgica (2018) 160:1891–189

Minimally invasive surgical approaches still provide limited exposure. Access to the L2–L5 intervertebral discs during a single procedure is challenging and often requires repositioning of the patient and adopting an alternative approach.

Objectives Investigate the windows to the L2–L5 intervertebral discs to assess the dimensions of the interbody implants suitable for the procedure and evaluate the feasibility of multi-level lumbar intervertebral disc surgery in robot-assisted surgery (RAS)

Methods Sixteen fresh-frozen cadaveric specimens underwent a retroperitoneal approach to access the L2–L5 intervertebral discs. The L2–L3 to L4–L5 windows were defined as the distance between the left lateral border of the aorta (or nearest common iliac vessel) and the medial border of the psoas, measured in a static state and after gentle medial retraction of the vascular structures. Two living porcine specimens and one cadaveric specimen underwent da Vinci robot-assisted transperitoneal approach to expose the L2–L3 to L4–L5 intervertebral discs and perform multi-level discectomy and interbody implant placement.

Results The L2–L3 to L4–L5 intervertebral disc windows significantly increased from a static to a retracted state (p < 0.05). The mean L2–L3, L3–L4, and L4–L5 windows measured respectively 20.1, 21.6, and 19.6 mm in the static state, and 27.2, 30.9, and 30.3 mm after gentle vascular retraction. The intervertebral windows from L2–L3 to L4–L5 were successfully exposed through an anterior transperitoneal approach with the da Vinci robot on the cadaveric and living porcine specimens, and interbody implants were inserted.

Conclusion RAS appears to be feasible for a mini-invasive multi-level lumbar intervertebral disc surgery. The RAS procedure, longer and more expensive than conventional MIS approaches, should be reserved for elective patients.