Robotics has remained a major area for research and development in spine surgery since the United States FDA approval of the first robotic guidance system in 2004.1 Over the past 3 decades the main focus of robot-assisted spine surgery has been trajectory guidance and the subsequent placement of thoracolumbar pedicle screws. Complications from pedicle screw malposition are well documented and may result in a significant burden on health resources, with the cost of revision surgery for a malpositioned screw estimated at $23,762.2 As a result, multiple advanced methods for the placement of spinal instrumentation have been developed beyond freehand, including fluoroscopic guidance and CT navigation. The reported incidence of screw-related complications in the literature is wide ranging, and multiple studies have sought to compare these techniques in order to determine superiority for accuracy, precision, and patient safety.3–6
Technological innovation that maximizes the safety, effectiveness, and efficiency of surgery is highly relevant in today’s healthcare environment, given an increasingly aging patient population with multiple medical comorbidities seeking advanced spine care.7 The addition of robotic technology, and most recently its combination with CT-guided navigation, is a promising technique with the potential to optimize the aforementioned parameters, without increasing cost as compared to conventional surgery.8 Several studies suggest superiority of robotic guidance compared to fluoroscopic or CT guidance with respect to accuracy of screw placement; however, many of these studies are limited by retrospective design, small sample sizes, and limited follow-up, partially due to the relatively recent development and clinical introduction of the technology.9–12
Making use of the largest database of current-generation robot-assisted thoracolumbar fusion surgery, we aim to determine the rates of intraoperatively or postoperatively identified screw malpositions requiring revision surgery, and we evaluate the overall 90-day complication, revision, and readmission rates as compared to the current body of literature.
Methods
A retrospective analysis of a multicenter database was performed. Eight centers contributed their experience with the Mazor X and/or Mazor X Stealth Edition (Mazor XSE) robotic guidance systems (Medtronic). Institutional review board approval was obtained at each of the respective study sites. A template for data collection was created with input from all contributing surgeons and, upon completion of individual retrospective chart reviews, a multicenter, deidentified database was produced. Patients 18 years of age or older who underwent open or minimally invasive, primary or revision thoracolumbar instrumented fusion surgery for degenerative spinal conditions and deformity were included in the study. Patients younger than 18 years of age or with diagnoses related to trauma, infection, and/or tumor were excluded.
Appropriate screw placement was confirmed fluoroscopically (C-arm) and/or with intraoperative cone-beam CT (O-arm) at each surgeon’s discretion. There was a roughly even split between confirmatory techniques among contributing surgeons. Screw placement is confirmed fluoroscopically by obtaining anteroposterior, lateral, and if necessary, en face or "owl’s-eye" views.13,14 If difficulty confirming placement with fluoroscopy was encountered, an O-arm spin was often performed. In addition to confirmatory radiography, 6 sites also routinely used neurophysiological monitoring to detect issues with screw placement.
Intraoperative and postoperative complications were reviewed separately. Intraoperative complications were subdivided into the following categories: implant-related, durotomy, and other. There were no patients with ≥ 2 intraoperative complications, allowing the calculation of rates by dividing the number of complications by the total number of surgeries performed. Conversely, the postoperative complication rate at 90 days is expressed as the complication incidence because there were instances of patients with ≥ 2 complications. Postoperative complications were further subdivided into the following categories: malpositioned screw resulting in new neurological symptoms, hardware failure, continued/progressive symptoms, surgical site infections, postoperative symptomatic hematoma/seroma, proximal junctional failure, general medical complications (defined as any adverse medical event occurring within 90 days), and other or not specified. Surgical revision and readmission rates (overall and implant-related) were calculated by dividing the number of revisions or readmissions by the total number of surgeries performed.
The aforementioned descriptive statistical analyses were performed, including frequency count, frequency percent, median, mean, and standard deviation. The SAS statistical software suite by SAS Institute was used for statistical analysis.
Results
Compiling the robotic experience of 8 high-volume spine centers from 2017 to 2020 yielded a total of 854 index surgical cases for patients age 18 years or older. After excluding diagnoses related to tumor, infection, or trauma and ensuring at least a 90-day follow-up, 799 surgical cases were identified. Patient demographic information and surgical characteristics are displayed in Table 1.
Demographics and surgical characteristics in 799 cases of robot-assisted surgery
Characteristic | Value |
---|---|
No. of surgical cases | 799 |
Age in yrs (mean ± SD) | 57.59 ± 12.86 |
Sex | |
Male | 341 (42.68%) |
Female | 458 (57.32%) |
ASA score (median) | 3 |
BMI (mean ± SD) | 29.50 ± 5.62 |
Robotic system | |
Mazor X | 390 (48.81%) |
Mazor XSE | 409 (51.19%) |
Instrumentation technique | |
Open | 305 (38.17%) |
Percutaneous | 494 (61.83%) |
Primary or revision surgery | |
Primary | 691 (86.48%) |
Revision | 108 (13.52%) |
Levels instrumented per case (mean ± SD) | 3.09 ± 2.90 |
ASA = American Society of Anesthesiologists; BMI = body mass index.
A roughly even split between use of the Mazor X and Mazor XSE robotic guidance systems was present (Mazor X: 48.81%; Mazor XSE: 51.19%). Percutaneous pedicle screws were placed in 494 (61.83%) cases and open pedicle screws in 305 (38.17%). The majority of surgical cases were primary (86.48%), whereas 13.52% involved revision surgery. A mean of 3.09 ± 2.90 spinal levels were instrumented per case.
Intraoperative Complications and Screw Malpositions
The overall intraoperative complication rate was 3.13% and was primarily accounted for by durotomies unrelated to instrumentation placement (Table 2). A total of 4838 pedicle screws were placed robotically (Table 3). Forty-eight (0.99% of total screws placed) pedicle screws were identified as malpositioned at the time of the index surgery and were replaced without any resulting vascular, neurological, or other complication. These screws were identified by either C-arm or O-arm imaging in conjunction with neurophysiological monitoring, if used. Of these, 25 were placed percutaneously and 23 were placed open, accounting for 1.01% and 0.97% of percutaneous and open screws, respectively. Postoperatively, however, 5 (0.10% of total screws placed) instances, in separate patients, of an unrecognized malpositioned screw causing new radicular symptoms were present. All 5 patients underwent revision surgery on the same admission, with improvement of their symptoms. Of these, 3 screws were placed percutaneously and 2 were placed open, accounting for 0.12% and 0.08% of percutaneous and open screws, respectively.
Complications, revisions, and readmissions in 129 patients with 799 index surgeries
Parameter | Value |
---|---|
Intraop complications | 25 (3.13%) |
Implant related | 0 (0%) |
Durotomy | 21 (2.63%) |
Other | 4 (0.50%) |
Total complications at 90 days | 146 (16.1% incidence) |
Pts w/ ≥2 complications | 16 (2%) |
Malpositioned screw causing radicular Sxs | 5 (3.42%) |
Hardware failure | 3 (2.05%) |
Continued/progressive Sxs | 31 (21.23%) |
Surgical site infection | 21 (14.38%) |
Postop hematoma/seroma | 8 (5.48%) |
Proximal junctional failure | 2 (1.37%) |
Medical | 70 (47.95%) |
Other | 6 (4.11%) |
Surgical revision w/in 90 days | 53 (6.63%) |
Implant related | 7 (0.88%) |
Malpositioned screw | 5 (0.63%) |
Hardware failure | 2 (0.25%) |
Readmission w/in 90 days | 57 (7.13%) |
Implant related | 2 (0.25%) |
Malpositioned screw | 0 (0%) |
Hardware failure | 2 (0.25%) |
Pts = patients; Sxs = symptoms.
Intraoperative and postoperative screw revisions—open versus percutaneous
Variable | Overall | Open | Percutaneous |
---|---|---|---|
Total no. of screws placed | 4838 | 2371 (49.0%) | 2467 (51.0%) |
No. of intraop screw revisions | 48 (0.99%) | 23 (0.97%) | 25 (1.01%) |
No. of postop screw revisions | 5 (0.10%) | 2 (0.08%) | 3 (0.12%) |
With respect to the robotic guidance system used, 21 (0.96%) screws placed with the Mazor X and 27 (1.02%) screws placed with the Mazor XSE required intraoperative revision (Table 4). The 5 screws requiring postoperative revision were all placed with the Mazor X, accounting for 0.23% of screws placed with the Mazor X.
Intraoperative and postoperative screw revisions—Mazor X versus Mazor XSE
Variable | Mazor X | Mazor XSE |
---|---|---|
Total no. of screws placed | 2194 | 2644 |
No. of intraop screw revisions | 21 (0.96%) | 27 (1.02%) |
No. of postop screw revisions | 5 (0.23%) | 0 (0%) |
Postoperative Complications Within 90 Days
One hundred twenty-nine patients suffered a total of 146 postoperative complications by 90 days following 799 index surgeries, representing a 16.1% incidence (Table 2). Of note, 16 patients suffered more than one postoperative complication.
Nearly half (70 recorded events accounting for 47.9%) of all postoperative complications within 90 days were classified as medical and included any adverse medical event occurring during this period. Thirty-one instances of continued pain or progressive symptoms were encountered within 90 days, representing 21.2% of all postoperative complications. Twenty-one surgical site infections representing 14.4% of all postoperative complications were encountered, with 8 developing within 30 days of surgery and 13 diagnosed between 30 and 90 days. In addition, 8 postoperative hematomas or seromas (5.48% of postoperative complications) developed during this time. Three instances of hardware failure and 2 instances of proximal junctional failure also occurred (2.05% and 1.37% of postoperative complications, respectively). Six other complications (not classifiable or specified) were encountered, including a pseudomeningocele treated with primary surgical dural repair and lumbar drain placement, a case of pseudarthrosis treated with revision surgery, and a case of presumed arachnoiditis.
Ninety-Day Surgical Revision and Readmission Rates
There were 53 surgical revisions occurring within 90 days, representing a surgical revision rate of 6.63% (Table 2). Of these, 7 were implant related, including 5 reoperations for malpositioned hardware and 2 for hardware failure. The overall rate of a symptomatic malpositioned screw requiring return to the operating room was 0.63%. In all cases this was recognized and the correction was performed during the index surgical admission. The remaining revisions were primarily accounted for by 14 wound washouts for surgical site infections, 7 hematoma/seroma evacuations, and 9 revisions for progressive/continued symptoms.
There were 57 readmissions within 90 days, representing an all-cause readmission rate of 7.13%. There were 2 cases of hardware failure requiring readmission and revision surgery, representing an implant-related readmission rate of 0.25%. The majority of readmissions were associated with revision surgery.
Discussion
Innovation in spine surgery is driven by the hope that technological advancement will improve the safety, effectiveness, and efficiency of spine surgery. The application of robotics in spine surgery is no exception, with significant interest and implementation occurring over the past 2 decades. Although several systematic reviews of the accumulated literature over this time have acknowledged the potential benefits of robot-assisted spine surgery, they agree that the available body of literature is limited and heterogeneous, making it difficult to adequately compare robotic guidance with other techniques.3–6
Adding a significant layer of complexity to the discussion of the current value of robotics in spine surgery is the fact that the vast majority of cited literature, including the few prospective randomized controlled trials and systematic reviews available, is based on previous-generation robotic systems.3–6,15,16 Current-generation robotic guidance systems including the Mazor XSE, Globus ExcelsiusGPS (Globus Medical), and ROSA ONE Spine (Zimmer Biomet) combine the latest robotic technology with real-time CT navigation, but have only recently come into commercial use—with FDA approvals in 2018, 2017, and 2019, respectively. Taking this into account, a limited amount of literature is available, albeit understandably, to evaluate these newer technologies.17–27 Recognizing the need for high-quality and relevant data with respect to current-generation robotic guidance systems, we have compiled the largest case series to date in which the Mazor X and Mazor XSE robotic guidance systems were used. Although it is not equipped with real-time CT navigation, the Mazor X was included in this series because it already represents a third-generation robotic guidance system.
Implant-Related Complications, Revisions, and Readmissions
Of 4838 total screws placed, 48 (0.99%) required replacement during the index surgical procedure and 5 (0.10%) required return to the operating room for screw revision on the same admission. Stated differently, 98.9% of robotically placed screws did not cause new radicular symptoms at 90 days. Although differences between surgical sites with respect to the radiographic evaluation of screw placement preclude a clear statement of accuracy from our data, recent literature suggests high accuracy of the Mazor X, Mazor XSE, and ExcelsiusGPS robotic guidance systems. Eleven studies that were identified through literature review reported accuracy rates ranging from 97.3% to 100% (Table 5).9,17–23,28–30 The majority of these studies used either the Gertzbein and Robbins (GR) scale or the Ravi criteria to determine screw accuracy. In those systems, a clinically acceptable position is typically defined as GR A or B, or Ravi I or II (< 2-mm pedicle breach as measured on CT).31,32 In the only publication to date evaluating the accuracy of the Mazor XSE, O’Connor et al. demonstrated 100% accuracy (GR A) for the first 90 pedicle screws placed, without any instrumentation-related complications.23 Similarly, Jain et al. reported 99% GR A or B accuracy in a series of 101 patients with 643 screws placed using the ExcelsiusGPS and no associated instrumentation-related complications or revisions.18 Of note, these studies report slightly higher accuracy rates than those reported in the literature for CT navigation (which is itself a component of the majority of these systems). A recent systematic review including 20 studies reporting the accuracy of pedicle screw placement with CT navigation found an overall accuracy of 95.5%.33 Data on how the combination of CT navigation with robotics affects perioperative variables such as intraoperative and postoperative complications, revisions, length of stay, narcotic use, and patient-reported outcome measures remain scant, and this represents a major target for future research.
Reported accuracy of current-generation robotic guidance systems
Authors & Year | Study Type | Device | Technique | No. of Pts | No. of Screws Placed | Accuracy | Grading Technique |
---|---|---|---|---|---|---|---|
O’Connor et al., 202123 | Technical note | Mazor XSE | Percutaneous | NS | 90 | 100% (A) | GR |
Huntsman et al., 202019 | Retro case series | ExcelsiusGPS | Percutaneous | 100 | 562 | 99% | Fluoroscopic confirmation |
Khan et al., 201928 | Retro cohort study | Mazor X | Percutaneous | 50 | 190 | 99.5% (I)/0.5% (II) | Ravi |
Khan et al., 201929 | Retro case series | Mazor X | Percutaneous | 20 | 75 | 98.1% (I)/1.3% (II) | Ravi |
Mao et al., 202030 | Retro cohort study | Mazor X | Percutaneous & open | 39 | 318 | 86.16% (A)/11.32% (B) | GR |
Godzik et al., 201920 | Retro case series | ExcelsiusGPS | Percutaneous | 31 | 116 | 96.6% (I)/2.59% (II) | Ravi |
Jiang et al., 20209 | Retro cohort study | ExcelsiusGPS | Percutaneous & open | 24 | 113 | 86.7% (A)/10.6% (B) | GR |
Vardiman et al., 202021 | Retro case series | ExcelsiusGPS | Percutaneous | 56 | 348 | 97.7% (A or B) | GR |
Jain et al., 201918 | Retro case series | ExcelsiusGPS | Percutaneous & open | 101 | 643 | 99% (A or B) | GR |
Benech et al., 202022 | Retro case series | ExcelsiusGPS | Percutaneous | 54 | 292 | 98.3% (A or B) | GR |
Fayed et al., 202017 | Retro cohort study | ExcelsiusGPS | Percutaneous | 20 | 100 | 94.2% (A)/3.88% (B) | GR |
NS = not specified; retro = retrospective.
Eight of the 11 studies included in our literature review exclusively studied robot-assisted percutaneous placement of pedicle screws.17,19–23,28,29 Surgeons using robotic guidance for open surgeries often report difficulty with excess tension on the robotic arm from the surrounding soft tissues that may adversely impact accuracy. In our series 2467 (51%) screws were placed percutaneously and 2371 (49%) were placed in open surgery (Table 3). Interestingly, slightly higher proportions of both intraoperative and postoperative screw revisions were associated with percutaneous placement. This difference, however, does not appear to be clinically significant and our data support the effective use of robotic guidance for both open and minimally invasive surgeries.
The implant-related complication rate was 0% in the 6 studies presenting this information.18,21–23,28,29 Likewise, the implant-related revision rate in the 5 studies reporting this was also 0%.18,19,21,22,28 In our series no intraoperatively identified complications resulted from screw placement, but 7 implant-related complications requiring revision occurred within 90 days, representing a rate of 0.88%. All 7 occurred within the first 30 days after surgery. Aided by the large number of screws included in this series, our findings support the previously documented low rates of implant-related complications and revisions.
Of the 7 implant-related complications requiring revision surgery, 5 involved a screw malposition causing a new radiculopathy that was identified in the acute postoperative period. In all cases revision surgery occurred on the same admission. Three of these surgeries were performed with percutaneous instrumentation and were without any significant neurophysiological monitoring findings. In 2 cases O-arm imaging confirmed minor breaches (lateral and superolateral) that were believed to be clinically insignificant; however, these resulted in a new postoperative radiculopathy. In another case in which intraoperative radiography was not concerning, the patient awoke with a new radiculopathy and CT demonstrated a minor lateral breach. In 1 open case, despite use of triggered electromyography and fluoroscopic verification of screw placement, the patient developed a new radiculopathy on postoperative day 1, with CT demonstrating an inferior breach. The second open case involved a fracture through the pedicle causing new radicular pain. Symptoms resolved after screw revision in all 5 cases. The remaining 2 implant-related complications requiring revision surgery involved hardware failure unrelated to robot usage.
Although a similar proportion of intraoperative screw revisions occurred in both Mazor X and Mazor XSE systems, it is important to note that all 5 screw malpositions requiring revision surgery occurred with the Mazor X (Table 4). This finding may argue for the benefit of combining real-time navigation with robotic guidance. This and more subtle technical nuances will certainly be drivers for future research. For instance, whether accuracy and/or surgical efficiency are impacted by the choice of registration imaging used (i.e., supine preoperative CT vs prone intraoperative CT) are important questions that may direct future research.
Overall Postoperative Complication, Revision, and Readmission Rates
Few studies have examined postoperative complication, revision, and readmission rates associated with robot-assisted spine surgery. A recent systematic review and meta-analysis of 32 studies comparing perioperative parameters among robot-guided, CT-navigated, and freehand thoracolumbar fusion surgery was unable to form any conclusions regarding overall complication rate given an almost total lack of robotic data.5 Not included in the aforementioned meta-analysis, Lieber et al. used the National Inpatient Sample to compare rates of major and minor postoperative complications between robot-guided and conventional lumbar fusion surgery.34 For robotic surgery they reported 31.91% and 8.17% rates of minor and major postoperative complications, respectively—however, multivariate analysis revealed no difference compared to conventional surgery. A more recent study by Yang et al. using the PearlDiver Research Program concluded that robotic guidance was associated with higher 30-day complication, revision, and readmission rates compared to conventional surgery.35 This study identified robot-assisted surgeries by using billing codes not exclusive to robotic guidance (for which a specific Current Procedural Terminology code does not currently exist), but rather generally applicable to computer-based navigation techniques including CT navigation.36 Opposed to this report is a retrospective analysis of a prospective database comparing robot-guided and freehand short-segment lumbar fusion surgery in which an 8.02% 90-day complication rate associated with robotic guidance and an 83.20% reduction in rate compared to the freehand technique (p < 0.001) were reported.37
In our series the overall incidence of postoperative complications within 90 days was 16.1%, with the majority of complications attributable to medical adverse events (47.9%) and pain-related complaints (21.2%). Seemingly large differences in complication rates may be related to varying definitions of complications between series and the time points at which they are captured in the literature. Such nonuniformity is apparent in multiple studies that have addressed complication rates following robotic spine surgery, and the resultant heterogeneity often precludes direct comparisons between series.15,16,38
With respect to surgical revisions specifically, a systematic review and meta-analysis by Schröder and Staartjes found higher revision rates in freehand compared to robot-assisted surgery (p < 0.001, OR 8.1).39 A follow-up meta-analysis, however, was unable to conclude superiority of robotic guidance, probably attributable to insufficient data.4 It is important to note, however, that the pooled incidence of malpositioned screws requiring postoperative revision was 2.1%. In the current series, the incidence of a malpositioned screw requiring subsequent revision surgery was only 0.63%. This low rate is consistent with reports specific to robotic guidance. Two randomized controlled trials and one of the included centers in this study’s previous series reported no instances of screw revision due to malposition.15,16,40 The rate of any surgical revision occurring within 90 days was 6.63%. Independent from revisions for screw malposition, data pertaining to all-cause revision rates for robotic surgery are extremely limited and inconsistent.30 Similarly, readmission rates following robot-assisted spine surgery are not widely documented. These deficiencies provide opportunities for future research and will be necessary to fully characterize the value of robotic spine surgery.
Limitations
The retrospective and multicenter design of this study introduces several limitations. First, heterogeneity between study sites exists, allowing for the possibility of both recognized and unrecognized confounding variables to be present with respect to differences in surgical technique and reporting. These differences preclude the possibility that a clear statement of accuracy can be made from this database because radiographic confirmation of screw placement was not standardized. In lieu of this, we report the rates of both intraoperative and postoperative screw revisions because of screw malposition. Another limitation inherent to retrospective studies is that complication and readmission rates are often underreported (e.g., patient may be admitted to another hospital). Although every attempt at compiling the most accurate database has been made, this possibility must still be mentioned.
Database research in general is limited by a lack of descriptive information for individual cases. As a result, granular details regarding specific complications and revisions that may otherwise have been instructive are not available. This limitation was balanced with our primary objective to present complication, revision, and readmission rates associated with the largest volume of robot-assisted surgeries compiled to date.
Finally, this study is limited by the fact that a direct comparison to other image-guidance techniques was not performed. As a case series with no control group, it is not possible to make direct conclusions as to how robotic assistance compares with other techniques; however, this provides an opportunity for future research.
Conclusions
This large retrospective, multicenter case series suggests that robot-assisted thoracolumbar pedicle screw instrumentation is associated with minimal intraoperative and postoperative complications related to implant placement. Ninety-day complication, revision, and readmission rates are low and comparable to what is currently documented in the literature. That being said, high-quality literature on these parameters specific to robot-assisted spine surgery is limited. Given this deficiency and the known high costs associated with postoperative complications and revisions, future large-volume, comparative, outcomes-based studies are critical to understanding the true value of robot-assisted spine surgery.
Disclosures
Dr. Khan has a research grant from the Scoliosis Research Society studying scoliosis development in patients with Chiari I malformation. Ms. Mao has a research grant from the AO Spine North America Foundation for the development of a 3D printed cervical spine model. Dr. Good has the following disclosures. Medtronic: grants/research support, consultant, advisory board member; Stryker: consultant, advisory board member, other financial or material support (royalties, patents, etc.); Mazor Robotics: consultant; Augmedics: stock/shareholder, advisory board member. Dr. Pollina has the following disclosures. Alphatec Spine: consultant, advisory board member; Medtronic: consultant, advisory board member. Dr. Haines has the following disclosures. Medtronic: consultant; 4Web: consultant; Globus Medical: consultant; Precision Spine: consultant. Dr. Gum has the following disclosures. Medtronic: consultant, advisory board member, other financial or material support (royalties, patents, etc.); K2M: consultant, advisory board member; NuVasive: consultant, grants/research support, other financial or material support (royalties, patents, etc.); Mazor Robotics: consultant; DePuy Synthes: speaker’s bureau; Acuity: other financial or material support (royalties, patents, etc.); Stryker: consultant, advisory board member; International Spine Study Group: grants/research support; Intellirod: grants/research support; Integra: grants/research support; Norton Healthcare: grants/research support, salaried employee. Dr. Schuler has the following disclosures. Medtronic: grants/research support. Dr. Jazini has the following disclosures. Medtronic: consultant; Stryker: consultant. Dr. Chua has the following disclosures. Medtronic: grants/research support, consultant, advisory board member. Dr. Shafa has the following disclosures. Medtronic: consultant, advisory board member; DePuy Synthes: consultant. Dr. Buchholz has the following disclosures. Medtronic: consultant, advisory board member; Siemens Healthcare: consultant; NuVasive: consultant; Alphatec Spine: consultant. Dr. Pham has the following disclosures. Medtronic: consultant, advisory board member. Dr. Poelstra has the following disclosures. Acuity Surgical: consultant; Atlas Spine: consultant; Innovative Surgical Devices: consultant; Flowpharma: distribution group; Kuros: research support; Inion OI: royalties; Stryker: royalties; Camber Spine: scientific advisory board; Society of Minimally Invasive Spine Surgery: scientific advisory board; Medtronic: speaking/teaching arrangements; North American Spine Society: other. Dr. Wang has the following disclosures. K2M: consultant; Stryker: consultant; DePuy Synthes: consultant, royalties; Spineology: consultant; Innovative Surgical Devices: stock/shareholder; Medical Device Partners: stock/shareholder; Medtronic: speaker’s bureau, advisory board member; Children’s Hospital of Los Angeles: royalties; Springer Publishing: royalties; Quality Medical Publishing: royalties; Globus Medical: speaker’s bureau; Kinesiometrics: stock/shareholder.
Author Contributions
Conception and design: Liounakos, Good, Pollina, Gum, Chua, Shafa, Buchholz, Pham, Poelstra, Wang. Acquisition of data: Liounakos, Khan, Eliahu, Mao, Good, Pollina, Haines, Gum, Gum, Jazini, Chua, Shafa, Buchholz, Pham, Wang. Analysis and interpretation of data: all authors. Drafting the article: Liounakos, Khan, Eliahu, Good, Chua, Wang. Critically revising the article: all authors. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: Liounakos. Statistical analysis: Liounakos, Eliahu. Administrative/technical/material support: Liounakos. Study supervision: Liounakos, Wang.
Supplemental Information
Previous Presentations
The results of this research were presented as a podium presentation at the International Meeting on Advanced Spine Techniques (IMAST) 2021 and accepted as an e-poster at the AANS 2021 annual meeting.
References
- 1↑
510(k) Premarket Notification—SpineAssist Device. U.S. Food and Drug Administration. Accessed September 16, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K033413
- 2↑
Larson AN, Polly DW Jr, Ackerman SJ, Ledonio CG, Lonner BS, Shah SA, et al. What would be the annual cost savings if fewer screws were used in adolescent idiopathic scoliosis treatment in the US? J Neurosurg Spine. 2016;24(1):116–123.
- 3
Yu L, Chen X, Margalit A, Peng H, Qiu G, Qian W. Robot-assisted vs freehand pedicle screw fixation in spine surgery—a systematic review and a meta-analysis of comparative studies. Int J Med Robot. 2018;14(3):e1892.
- 4↑
Staartjes VE, Klukowska AM, Schröder ML. Pedicle screw revision in robot-guided, navigated, and freehand thoracolumbar instrumentation: a systematic review and meta-analysis. World Neurosurg. 2018;116:433–443.e8.
- 5↑
Siccoli A, Klukowska AM, Schröder ML, Staartjes VE. A systematic review and meta-analysis of perioperative parameters in robot-guided, navigated, and freehand thoracolumbar pedicle screw instrumentation. World Neurosurg. 2019;127:576–587.e5.
- 6
Joseph JR, Smith BW, Liu X, Park P. Current applications of robotics in spine surgery: a systematic review of the literature. Neurosurg Focus. 2017;42(5):E2.
- 7↑
Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in lumbar fusion procedure rates and associated hospital costs for degenerative spinal diseases in the United States, 2004 to 2015.Spine (Phila Pa 1976).2019;44(5):369–376.
- 8↑
Ver MLP, Gum JL, Crawford CH, Djurasovic M, Owens RK, Brown M, et al. Index episode-of-care propensity-matched comparison of transforaminal lumbar interbody fusion (TLIF) techniques: open traditional TLIF versus midline lumbar interbody fusion (MIDLIF) versus robot-assisted MIDLIF. J Neurosurg Spine. 2020;32(5):741–747.
- 9↑
Jiang B, Pennington Z, Azad T, Liu A, Ahmed AK, Zygourakis CC, et al. Robot-assisted versus freehand instrumentation in short-segment lumbar fusion: experience with real-time image-guided spinal robot. World Neurosurg. 2020;136:e635–e645.
- 10
Kochanski RB, Lombardi JM, Laratta JL, Lehman RA, O’Toole JE. Image-guided navigation and robotics in spine surgery. Neurosurgery. 2019;84(6):1179–1189.
- 11
Schatlo B, Molliqaj G, Cuvinciuc V, Kotowski M, Schaller K, Tessitore E. Safety and accuracy of robot-assisted versus fluoroscopy-guided pedicle screw insertion for degenerative diseases of the lumbar spine: a matched cohort comparison. J Neurosurg Spine. 2014;20(6):636–643.
- 12
Fichtner J, Hofmann N, Rienmüller A, Buchmann N, Gempt J, Kirschke JS, et al. Revision rate of misplaced pedicle screws of the thoracolumbar spine-comparison of three-dimensional fluoroscopy navigation with freehand placement: a systematic analysis and review of the literature. World Neurosurg. 2018;109:e24–e32.
- 13↑
Idler C, Rolfe KW, Gorek JE. Accuracy of percutaneous lumbar pedicle screw placement using the oblique or "owl’s-eye" view and novel guidance technology. J Neurosurg Spine. 2010;13(4):509–515.
- 14↑
Anderson DG, Samartzis D, Shen FH, Tannoury C. Percutaneous instrumentation of the thoracic and lumbar spine. Orthop Clin North Am. 2007;38(3):401–408,vii.
- 15↑
Hyun SJ, Kim KJ, Jahng TA, Kim HJ. Minimally invasive robotic versus open fluoroscopic-guided spinal instrumented fusions: a randomized controlled trial. Spine (Phila Pa 1976).2017;42(6):353–358.
- 16↑
Kim HJ, Jung WI, Chang BS, Lee CK, Kang KT, Yeom JS. A prospective, randomized, controlled trial of robot-assisted vs freehand pedicle screw fixation in spine surgery. Int J Med Robot. 2017;13(3):e1779.
- 17↑
Fayed I, Tai A, Triano M, Sayah A, Makariou E, Voyadzis JM, Sandhu FA. Robot-assisted percutaneous pedicle screw placement: evaluation of accuracy of the first 100 screws and comparison with cohort of fluoroscopy-guided screws. World Neurosurg. 2020;143:e492–e502.
- 18↑
Jain D, Manning J, Lord E, Protopsaltis T, Kim Y, Buckland AJ, et al. Initial single-institution experience with a novel robotic-navigation system for thoracolumbar pedicle screw and pelvic screw placement with 643 screws. Int J Spine Surg. 2019;13(5):459–463.
- 19↑
Huntsman KT, Ahrendtsen LA, Riggleman JR, Ledonio CG. Robotic-assisted navigated minimally invasive pedicle screw placement in the first 100 cases at a single institution. J Robot Surg. 2020;14(1):199–203.
- 20↑
Godzik J, Walker CT, Hartman C, de Andrada B, Morgan CD, Mastorakos G, et al. A quantitative assessment of the accuracy and reliability of robotically guided percutaneous pedicle screw placement: technique and application accuracy. Oper Neurosurg (Hagerstown). 2019;17(4):389–395.
- 21↑
Vardiman AB, Wallace DJ, Crawford NR, Riggleman JR, Ahrendtsen LA, Ledonio CG. Pedicle screw accuracy in clinical utilization of minimally invasive navigated robot-assisted spine surgery. J Robot Surg. 2020;14(3):409–413.
- 22↑
Benech CA, Perez R, Benech F, Greeley SL, Crawford N, Ledonio C. Navigated robotic assistance results in improved screw accuracy and positive clinical outcomes: an evaluation of the first 54 cases. J Robot Surg. 2020;14(3):431–437.
- 23↑
O’Connor TE, O’Hehir MM, Khan A, Mao JZ, Levy LC, Mullin JP, Pollina J. Mazor X Stealth robotic technology: a technical note. World Neurosurg. 2021;145:435–442.
- 24
Pham MH, Plonsker J, Diaz-Aguilar LD, Osorio JA, Lehman RA. Simultaneous robotic single-position surgery with oblique lumbar interbody fusion with software planning: 2-dimensional operative video. Oper Neurosurg (Hagerstown). 2021;20(5):E363.
- 25
Buza JA III, Good CR, Lehman RA Jr, Pollina J, Chua RV, Buchholz AL, Gum JL. Robotic-assisted cortical bone trajectory (CBT) screws using the Mazor X Stealth Edition (MXSE) system: workflow and technical tips for safe and efficient use. J Robot Surg. 2021;15(1):13–23.
- 26
Pham MH, Osorio JA, Lehman RA. Navigated spinal robotics in minimally invasive spine surgery, with preoperative and intraoperative workflows: 2-dimensional operative video. Oper Neurosurg (Hagerstown). 2020;19(4):E422.
- 27
Pham MH, Diaz-Aguilar LD, King BH, Osorio JA, Lehman RA. Quad S2-alar-iliac screw fixation via navigated spinal robotics with software planning: 2-dimensional operative video. Oper Neurosurg (Hagerstown). 2020;19(5):E523.
- 28↑
Khan A, Meyers JE, Yavorek S, O’Connor TE, Siasios I, Mullin JP, Pollina J. Comparing next-generation robotic technology with 3-dimensional computed tomography navigation technology for the insertion of posterior pedicle screws. World Neurosurg. 2019;123:e474–e481.
- 29↑
Khan A, Meyers JE, Siasios I, Pollina J. Next-generation robotic spine surgery: first report on feasibility, safety, and learning curve. Oper Neurosurg (Hagerstown). 2019;17(1):61–69.
- 30↑
Mao G, Gigliotti MJ, Myers D, Yu A, Whiting D. Single-surgeon direct comparison of O-arm neuronavigation versus Mazor X robotic-guided posterior spinal instrumentation. World Neurosurg. 2020;137:e278–e285.
- 31↑
Ravi B, Zahrai A, Rampersaud R. Clinical accuracy of computer-assisted two-dimensional fluoroscopy for the percutaneous placement of lumbosacral pedicle screws. Spine (Phila Pa 1976).2011;36(1):84–91.
- 32↑
Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976).1990;15(1):11–14.
- 33↑
Mason A, Paulsen R, Babuska JM, Rajpal S, Burneikiene S, Nelson EL, Villavicencio AT. The accuracy of pedicle screw placement using intraoperative image guidance systems. J Neurosurg Spine. 2014;20(2):196–203.
- 34↑
Lieber AM, Kirchner GJ, Kerbel YE, Khalsa AS. Robotic-assisted pedicle screw placement fails to reduce overall postoperative complications in fusion surgery. Spine J. 2019;19(2):212–217.
- 35↑
Yang DS, Li NY, Kleinhenz DT, Patel S, Daniels AH. Risk of postoperative complications and revision surgery following robot-assisted posterior lumbar spinal fusion. Spine (Phila Pa 1976).2020;45(24):E1692–E1698.
- 36↑
Malik AT, Drain JP, Karnes JM. Letter to the Editor regarding "Risk of postoperative complications and revision surgery following robot-assisted posterior lumbar spinal fusion". Spine (Phila Pa 1976).2021;46(6):E411–E412.
- 37↑
Liounakos JI, Kumar V, Jamshidi A, Silman Z, Good CR, Schroerlucke SR, et al. Reduction in complication and revision rates for robotic-guided short-segment lumbar fusion surgery: results of a prospective, multi-center study. J Robot Surg. 2021;15(5):793–802.
- 38↑
Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011;20(6):860–868.
- 39↑
Schröder ML, Staartjes VE. Revisions for screw malposition and clinical outcomes after robot-guided lumbar fusion for spondylolisthesis. Neurosurg Focus. 2017;42(5):E12.
- 40↑
Urakov TM, Chang KH, Burks SS, Wang MY. Initial academic experience and learning curve with robotic spine instrumentation. Neurosurg Focus. 2017;42(5):E4.