21 results on '"Avrumova F"'
Search Results
2. Navigation of Pedicle Screws with Augmented Reality versus Robotic-assisted Surgery
- Author
-
Altorfer, F.C.S., Kelly, M., Avrumova, F., Burkhard, M., Zhu, J., Abel, F., Cammisa, F.P., Sama, A.A., and Lebl, D.R.
- Published
- 2024
- Full Text
- View/download PDF
3. Robotic Pedicle Screw Placement with 3D MRI Registration: Moving Towards Radiation Free Robotic Spine Surgery.
- Author
-
Altorfer FCS, Kelly MJ, Avrumova F, Burkhard MD, Sneag DB, Campbell G, Chazen JL, Tan ET, and Lebl DR
- Abstract
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., (Copyright © 2024. Published by Elsevier Inc.)
- Published
- 2024
- Full Text
- View/download PDF
4. Reasons for Revision Surgery After Cervical Disk Arthroplasty Based on Medical Device Reports Maintained by the US Food and Drug Administration.
- Author
-
Altorfer FCS, Kelly MJ, Avrumova F, Zhu J, Abjornson C, and Lebl DR
- Subjects
- Humans, United States, Retrospective Studies, Postoperative Complications etiology, Postoperative Complications epidemiology, Intervertebral Disc Degeneration surgery, Databases, Factual, Diskectomy adverse effects, Diskectomy methods, Diskectomy instrumentation, Arthroplasty adverse effects, Arthroplasty instrumentation, Arthroplasty methods, Cervical Vertebrae surgery, Reoperation statistics & numerical data, United States Food and Drug Administration, Total Disc Replacement adverse effects, Total Disc Replacement instrumentation, Total Disc Replacement methods
- Abstract
Study Design: Retrospective database review., Objective: The aim of this study was to analyze revisions of CDAs reported to the MAUDE database., Summary of Background Data: Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs., Methods: The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared., Results: A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify., Conclusions: The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA., Level of Evidence: Level II., Competing Interests: C.A. is a consultant on the advisory board for Camber Spine Tech; a consultant for Centinel Spine Inc.; is in the advisory board, and has an ownership interest in Orthobond Corporation and Surgalign. D.R.L. is a consultant and on the advisory board for Choice Spine; is a consultant for Depuy Synthes; has ownership interest from Woven Orthopedic Technologies, Vestia Ventures MiRus Investment LLC, HS2 LLC, and ISPH II LLC; has research support from Medtronic Sofamor Danek USA Inc.; has royalties from Nuvasive Inc.; is on the advisory board and has ownership interest from Remedy Logic; is a consultant and has royalties from Stryker; is a consultant and has ownership interest from Viseon Inc. The remaining authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
5. Efficacy of an allograft cellular bone matrix as an alternative to autograft in anterior cervical discectomy and fusion: radiological results & safety.
- Author
-
Goldman SN, Paschal GK, Mani K, Abel F, Avrumova F, Sama AA, Cammisa FP Jr, and Abjornson C
- Abstract
Background: The predominant surgical procedure employed for patients with symptomatic cervical radiculopathy is anterior cervical discectomy and fusion (ACDF). ACDF typically involves the use of an interbody cage augmented with iliac crest bone graft (ICBG) or local autograft to enhance fusion rate. Substantial complications can arise from autograft use, including donor site morbidity, difficulties with ambulation, and diminished quality of life. This study aims to evaluate the effectiveness and safety of an allograft cellular bone matrix (ACBM) as an osteopromotive bone, in ACDF procedures., Methods: This retrospective, single-center, consecutive case series included 73 patients who underwent an ACDF procedure. The surgical procedure involved the placement of an interbody cage supplemented with anterior plate fixation and an ACBM within the interbody spacer. Patient charts were reviewed to gather demographic information, radiographic findings, as well as perioperative and post-operative complications. Radiographic fusion was assessed at 6 and 12 months by a blinded, musculoskeletal-trained radiologist and a board-certified spinal surgeon reviewer. Any discrepancies were settled by a third, senior reviewer. Complete fusion was defined as: evidence of bridging bone across the disc space on CT, angular motion <3 degrees, and translational motion <2 mm on lateral radiographs. Complications were analyzed at 6, 12, and 15+ months post-operatively to assess clinical outcomes and device performance., Results: A total of 73 patients (50 males, 23 females) with an average age of 54.6 (range, 31-77) years underwent an ACDF procedure between C3-T1 with an ACBM. The breakdown of levels operated on was 26%, 32%, 34%, and 8% for one, two, three, and four level procedures, respectively. There were three patients who received spinal injections for pain within the first year post-operatively. There were two patients who required secondary surgery within the first 12 months where supplemental posterior hardware was needed. Notably, there were no instances of cage subsidence, cage migration, cage/graft removal, or reoperation. There were no cases of chronic dysphasia. At 6 months, 45% of patients with available imaging demonstrated complete fusion, while 97.4% of patients with available imaging demonstrated complete fusion at 12 months., Conclusions: At the 12-month follow-up, our study demonstrates a high fusion rate in a real-world population of up to 4 operative levels. There were no bone graft related complications or incidences of cage migration/subsidence. It is noteworthy that the study involved a significant number of multilevel cases (74% of cases). Despite this, our results align with historical fusion rates and provide support for the utilization of ACBMs as a fusion adjunct in ACDF procedures up to 4 levels., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jss.amegroups.com/article/view/10.21037/jss-23-142/coif). A.A.S. reports the royalties from Ortho Development Corp, consulting fees from Clariance Inc., Depuy Synthes Products Inc., Kuros Biosciences, and Ortho Development Inc.; the ownership interest with Centinel Spine, HSS ASC Development Network LLC, HS2 LLC, ISPH 3 Holdings LLC, ISPH II LLC, VBros Venture Partners X, Vestia Ventures MiRus Investment, LLC. He also participated in the Scientific Advisory Board of Clariance Inc., Depuy Synthes Products Inc., and Kuros Biosciences. FPC reports the royalties from Accelus-Consultant, consulting fees from 4Web Medical, Synexis LLC, NuVasive Inc., Spine Biopharma LLC; ownership interest with 4Web Medical, HealthPoint Capital Partners LP, Ivy Healthcare Capital Partners LLC, ISPH 3 Holdings LLC, ISPH II LLC, Orthobond Corp, Spine Biopharma, Tissue Differentiation Intelligence LLC, VBVP VI LLC, VBVP X LLC, Woven Orthopedic Technologies. He also participates in 4Web Medical, HealthPoint Capital Partners LP, Orthobond Corp., and Wove Orthopedic Technologies. CA reports consulting fees from Camber Spine Tech, and Centinel Spine Tech; ownership interest with Orthobond Corporation. She also participates in the advisory board of Camber Spine Tech and Orthobond Corporation. The other authors have no conflicts of interest to declare., (2024 AME Publishing Company. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
6. Surgical technique of 3D computer-assisted navigated posterior fixation of the upper cervical spine: illustration of three cases.
- Author
-
Altorfer FCS, Avrumova F, Paschal G, Burkhard MD, and Lebl DR
- Abstract
Instrumentation of the upper cervical spine, such as cervical pedicle, lateral mass, pars, or translaminar screws, is considered high risk due to the specific challenges of this anatomic region, including the proximity of vertebral and carotid arteries and nerve roots, as well as its delicate bony architecture. In recent years, advanced three-dimensional (3D) imaging techniques, such as intraoperative computed tomography (iCT; AIRO CT), have emerged, enabling computer-assisted navigation (CAN). This integration of real-time imaging into navigation enhances screw accuracy and diminishes perioperative risks, extending to the postsurgical confirmation of screw placement. Although CAN utilization has become more prominent in lumbar and thoracic surgeries, its integration into cervical spine procedures has been constrained thus far. This can be ascribed to the variable screw trajectories necessary for cervical spine procedures, coupled with potential anatomical variations such as a high-riding vertebral artery, increasing the degree of challenge during surgery. To date, no study has comprehensively described in detail the technique of upper cervical instrumentation employing automatic image registration, navigation, and iCT validation of the positioned screws. In this manuscript, a detailed description of CAN in high cervical instrumentation is given, including C1 lateral mass screws with the notching technique, C2 and C3 pars screws, and translaminar screws guided by preoperative magnetic resonance imaging (MRI) data and iCT for assessment of screw position. For this purpose, three different patients suffering from distinct cervical pathologies, such as nonunion of a C2 fracture and atlantoaxial arthropathy with or without ankylosis, are presented, with a specific surgical approach tailored to the anatomical variations of each patient., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jss.amegroups.com/article/view/10.21037/jss-24-26/coif). D.R.L. reports research support from Medtronic; royalties from NuVasive, Inc. and Stryker; consulting fee from Depuy Synthes and Vizeon, Inc.; private investments from HS2, LLC, Woven Orthopedic Technologies, Vestia Ventures MiRus Investiment LLC, ISPH, and LLC; and he is the member of scientific advisory board of Remedy Logic. The other authors have no conflicts of interest to declare., (2024 AME Publishing Company. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
7. Pedicle Screw Placement with Augmented Reality Versus Robotic-Assisted Surgery.
- Author
-
Altorfer FCS, Kelly MJ, Avrumova F, Burkhard MD, Zhu J, Abel F, Cammisa FP, Sama A, Farshad M, and Lebl DR
- Abstract
Study Design: This was a single-center prospective clinical and radiographic analysis of pedicle screw instrumentation with Robotic-assisted navigation (RAN) and augmented reality (AR)., Objective: This study aimed to compare the accuracy of lumbosacral pedicle screw placement with RAN versus AR., Summary of Background Data: RAN and AR have demonstrated superior accuracy in lumbar pedicle screw placement compared to conventional free-hand techniques. RAN and AR techniques both tout specific advantages over their counterparts, but to date, no study has directly compared the two technologies regarding pedicle screw accuracy., Patients and Methods: Patients who underwent RAN or head-mounted AR navigated lumbosacral (L1-S1) pedicle screw placement for degenerative conditions were included. Screw accuracy was assessed by two independent reviewers on intraoperative 3D fluoroscopic scans using the Gertzbein and Robbins scale. A generalized linear mixed model was applied to evaluate the relationship between the screw placement technique and accuracy., Results: 212 patients undergoing lumbosacral instrumentation with a total of 1,211 pedicle screws placed using RAN (n=108; screws= 827) or AR (n=104; screws= 384). Overall, Grade A was achieved in 92.6% of screws. No significant difference was found between RAN and AR screw placement regarding the incidence of accurate (Grade-A and -B screws; RAN n=824; 99.6% and AR n=379, 98.7%) versus inaccurate screws (Grade-C and -D screws; RAN n=3, 0.4% and AR n=5, 1.3%). When comparing "optimal" Grade-A screws (RAN n= 787, 95.2%, AR n=345, 89.8%) versus all other screws (B, C, and D), significantly higher accuracy was achieved using RAN (P=0.001)., Conclusion: RAN and AR both achieved high accuracy in lumbosacral pedicle screw placement, proving reliable for this procedure. However, RAN resulted in significantly more Grade-A screw placements than AR., Competing Interests: Conflict of interest disclosure: FCSA, MJK, FA, MDB, JZ, and FA do not have a conflict of interest in this study. FPC received research support and/or has an ownership interest in 4WEB Medical/4WEB, Inc., Camber Spine, Centinel Spine, Choice Spine, DePuy Synthes, and Royal Biologics. Has ownership interests in 4WEB Medical/4WEB, Inc., Healthpoint Capital Partners, LP, ISPH II, LLC, where FPC is also in the advisory board, ISPH 3 Holdings, LLC, Ivy Healthcare Capital Partners, LLC, Medical Device Partners II, LLC, Medical Device Partners III, LLC, where FPC is also in the Board of directors, Orthobond Corporation, where FPC is on the board of directors, Spine Biopharma, LLC, Tissue Differentiation Intelligence, LLC, Tissue Connect Systems, Inc., VBVP VI, LLC, VBVP X, LLC, and Woven Orthopedic Technologies, where FPC is also in the Board of directors. FPC has consulting and royalty agreements with Accelus and Spine Biopharma, LLC, with royalties specifically for the “Toro” titanium, bi-planar expandable, lumbar spine interbody implant designed for insertion via lateral approach from Accelus. FCP is in the board of Director positions with Medical Device Partners II, LLC, Orthobond Corporation, Spine Biopharma, LLC, with ownership interest, and Woven Orthopedic Technologies. FCP is on the Advisory Board and has ownership interest with Healthpoint Capital Partners, LP. AS has Ownership Interest from Centinel Spine (Vbros Venture Partners V), HSS ASC Development Network, LLC, HS2, LLC, ISPH 3 Holdings, LLC, ISPH II, LLC, VBros Venture Partners X, and Vestia Ventures MiRus Investment, LLC. AS is a Consultant and on the Scientific Advisory Board for Clariance, Inc. AS is on the Advisory Board and a Consultant for Depuy Synthes Products, Inc. (a Johnson & Johnson Company). AS is a Consultant and on the Strategic Advisory Board for Kuros Biosciences. AS is a Consultant and has Royalties from Ortho Development Corp. MF is Consultant for Arthrex and Medacta, and President of the Board and shareholder of Moving Spine DRL is a Consultant and on the Advisory Board for Choice Spine. DRL is a consultant for Depuy Synthes. DRL has Ownership Interest from Woven Orthopedic Technologies, Vestia Ventures MiRus Investment LLC HS2, LLC and ISPH II, LLC. DRL has Research Support from Medtronic Sofamor Danek USA, Inc. DRL has Royalties from Nuvasive, Inc. DRL is on the Advisory Board and has Ownership Interest from Remedy Logic. DRL is a Consultant and has Royalties from Stryker. DRL is a Consultant and has Ownership Interest from Viseon, Inc., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
8. Cervical Disk Arthroplasty: Updated Considerations of an Evolving Technology.
- Author
-
Altorfer FCS, Avrumova F, Abjornson C, and Lebl DR
- Abstract
For years, anterior cervical diskectomy and fusion has been considered the benchmark for patients with cervical radiculopathy/myelopathy. However, concerns regarding adjacent segment pathology have promoted the popularity of cervical disk arthroplasty (CDA) with its motion-preserving properties. To replicate the natural cervical disk's six degrees of freedom and compressibility in cervical spine implants, designers need to carefully consider the level of constraint for stability and material selection. Recent CDA designs have incorporated strategies to facilitate unrestricted or semirestricted motion, deploying various articulating components and materials with distinct wear and compressibility properties. To optimize outcomes, patient selection considering additional degeneration of the cervical spine is critical. Clinical long-term studies have been reported in industry-funded FDA investigational device exemption and nonindustry-funded data for one-level and two-level CDA. There are limited data available on three-level and four-level CDA. Adverse events such as heterotopic ossification, osteolysis, migration, subsidence, and failure have been described, where analysis from explanted devices yields insight into in vivo wear and impingement performance. CDA has shown short-term cost advantages, such as decreased procedural expenses. Nonetheless, long-term analysis is necessary to assess possible economic tradeoffs. Advancements in designs may lead to improved implant longevity while evidence-based decision making will guide and responsibly manage the rapid advancement in CDA technology., (Copyright © 2024 by the American Academy of Orthopaedic Surgeons.)
- Published
- 2024
- Full Text
- View/download PDF
9. Assessing intraoperative pedicle screw placement accuracy using biplanar radiographs compared to three-dimensional imaging.
- Author
-
Gorgy G, Avrumova F, Paschal PK, Paschal GK, Carrino JA, and Lebl DR
- Subjects
- Adult, Humans, Imaging, Three-Dimensional, Radiography, Tomography, X-Ray Computed, Pedicle Screws, Robotic Surgical Procedures methods
- Abstract
To date, biplanar imaging (2D) has been the method of choice for pedicle screw (PS) positioning and verified for the anteroposterior view and (spinal midline) M-line method. In recent years, the use of intraoperative three-dimensional (3D) imaging has become available with the Gertzbein-Robbins system (GRS) to assess PS breach and positioning confirmation. The aim is to determine if 2D imaging is sufficient to assess PS position in comparison to advanced 3D imaging.Retrospective review of prospectively collected data from 204 consecutive adult patients who underwent posterior thoracic and lumbar instrumented fusion for degenerative spinal surgery by a single surgeon (2019-2022).Of the 204 patients, 187 (91.6%) had intraoperative images available for analysis. A total of 1044 PS implants were used; 922 (88.3%) were robotically placed. Postoperative CT scans were verified with M-line/GRS findings. Among 103 patients (50.5%) with a total of 362 screws, (34.7%) had postoperative CT, intraoperative 3D scan, and intraoperative 2D scan for analysis. Postoperative CT findings were consistent with all GRS findings, validating that 3D imaging was accurate. Screws (1%) were falsely verified by the M-line as 3D imaging confirmed false negative or positive findings.In our series, intraoperative 3D scan was as accurate as postoperative CT scan in assessing PS breach. A significant number of PS may be falsely read as accurate on 2D imaging, that is in fact inaccurate when assessed on 3D imaging. An intraoperative post-instrumentation 3D scan may be preferable to prevent postoperative recognition of a falsely verified screw on biplanar imaging., (© 2024. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.)
- Published
- 2024
- Full Text
- View/download PDF
10. Robot-Assisted Lumbar Pedicle Screw Placement Based on 3D Magnetic Resonance Imaging.
- Author
-
Altorfer FCS, Burkhard MD, Kelly MJ, Avrumova F, Sneag DB, Chazen JL, Tan ET, and Lebl DR
- Abstract
Study Design: Human Cadaveric Study., Objective: This study aims to explore the feasibility of using preoperative magnetic resonance imaging (MRI), zero-time-echo (ZTE) and spoiled gradient echo (SPGR), as source data for robotic-assisted spine surgery and assess the accuracy of pedicle screws., Methods: Zero-time-echo and SPGR MRI scans were conducted on a human cadaver. These images were manually post-processed, producing a computed tomography (CT)-like contrast. The Mazor X robot was used for lumbar pedicle screw-place navigating of MRI. The cadaver underwent a postoperative CT scan to determine the actual position of the navigated screws., Results: Ten lumbar pedicle screws were robotically navigated of MRI (4 ZTE; 6 SPGR). All MR-navigated screws were graded A on the Gertzbein-Robbins scale. Comparing preoperative robotic planning to postoperative CT scan trajectories: The screws showed a median deviation of overall 0.25 mm (0.0; 1.3), in the axial plane 0.27 mm (0.0; 1.3), and in the sagittal plane 0.24 mm (0.0; 0.7)., Conclusion: This study demonstrates the first successful registration of MRI sequences, ZTE and SPGR, in robotic spine surgery here used for intraoperative navigation of lumbar pedicle screws achieving sufficient accuracy, showcasing potential progress toward radiation-free spine surgery., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
- Published
- 2024
- Full Text
- View/download PDF
11. Anterior cervical osteotomy of diffuse idiopathic skeletal hyperostosis lesions with computer-assisted navigation surgery: A case report.
- Author
-
Avrumova F, Goldman SN, Altorfer F, Paschal GK, and Lebl DR
- Abstract
Key Clinical Message: Diffuse idiopathic skeletal hyperostosis (DISH) involves spine ligament ossification. Computer-assisted navigation (CAN) effectively aids complex surgeries, such as anterior cervical osteotomy, to alleviate progressive DISH-related dysphagia., Abstract: We describe a 68-year-old man with sudden onset dysphagia to both solids and liquids. Radiographic Imaging revealed DISH lesions from C2 down to the thoracic spine. The patient was successfully treated with CAN anterior osteotomy and resection of DISH lesions from C3-C6 and had complete symptom relief within 2 weeks post-operatively., Competing Interests: Fedan Avrumova, Samuel N. Goldman, Franziska Altorfer, and Gregory K. Paschal do not have any conflicts of interest to disclose. Darren R. Lebl reports royalties from Stryker, royalties from NuVasive, ownership interest from Woven Orthopedic Technologies, ownership interest from Viseon, Inc, ownership interest from Vestia Ventures MiRus Investment LLC, ownership interest from ISPH II, LLC, ownership interest from HS2, LLC, ownership interest from Remedy Logic, on the advisory board for Remedy Logic, on the advisory board for Choice Spine, a consultant for Choice Spine, a consultant for Depuy Synthes and a consultant for Viseon, Inc outside the submitted work., (© 2024 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.)
- Published
- 2024
- Full Text
- View/download PDF
12. Prospective Comparison of Two Robotically Navigated Pedicle Screw Instrumentation Techniques.
- Author
-
Avrumova F, Abel F, Zelenty WD, Goldman SN, and Lebl DR
- Subjects
- Humans, Fluoroscopy methods, RNA, Pedicle Screws adverse effects, Robotic Surgical Procedures methods, Surgery, Computer-Assisted methods
- Abstract
This study aimed to compare screw accuracy and incidence of skive between two robotically navigated instrumented techniques in posterior spine fusion surgery: manual anti-skive instrumentation with an anti-skive cannula (ASC) and the use of a navigated, high-speed drill (HSD). Over a 3-year period, consecutive patients are undergoing RNA posterior fusion surgery with either ASC (n = 53) or HSD (n = 63). Both groups met a value of approximately 292 screws in our analysis (296 ASC, 294 HSD), which was determined by a biostatistician at an academic institution. Screw accuracy and skive was analyzed using preoperative CT and intraoperative three-dimensional (3D) fluoroscopy. Among 590 planned robotically inserted pedicle screws (296 ASC, 294 HSD), 245 ASC screws (82.8%) and 283 HSD screws (96.3%) were successfully inserted (p < 0.05). Skive events occurred in 4/283 (1.4%) HSD screws and 15/245 (6.2%) ASC screws (p < 0.05). HSD screws showed better accuracy in the axial and sagittal planes, being closer to planned trajectories in all directions except cranial deviation (p < 0.05). Additionally, HSD had a significantly lower time per screw (1.9 ± 1.0 min) compared to ASC (3.2 ± 2.0 min, p < 0.001). No adverse clinical effects were observed. The HSD technique showed significant improvements in time and screw accuracy compared to ASC. Biplanar fluoroscopy and 3D imaging resulted in significantly lower radiation exposure and time compared to ASC. These significant findings in the HSD group may be attributed to the lower occurrence of malpositioned screws, leading to a decrease in the need for second authentication. This represents a notable iterative improvement of the RNA platform., (© 2023. The Author(s), under exclusive licence to Springer-Verlag London Ltd., part of Springer Nature.)
- Published
- 2023
- Full Text
- View/download PDF
13. Robotic-navigated assistance in spine surgery.
- Author
-
Abel F, Avrumova F, Goldman SN, Abjornson C, and Lebl DR
- Subjects
- Adult, Humans, Retrospective Studies, Spine surgery, Lumbar Vertebrae diagnostic imaging, Lumbar Vertebrae surgery, RNA, Robotics, Robotic Surgical Procedures methods, Surgery, Computer-Assisted methods, Pedicle Screws, Spinal Fusion methods
- Abstract
The aim of this study was to assess the accuracy of pedicle screw placement, as well as intraoperative factors, radiation exposure, and complication rates in adult patients with degenerative disorders of the thoracic and lumbar spines who have undergone robotic-navigated spinal surgery using a contemporary system. The authors reviewed the prospectively collected data on 196 adult patients who had pedicle screws implanted with robot-navigated assistance (RNA) using the Mazor X Stealth system between June 2019 and March 2022. Pedicle screws were implanted by one experienced spinal surgeon after completion of a learning period. The accuracy of pedicle screw placement was determined using intraoperative 3D fluoroscopy. A total of 1,123 pedicle screws were implanted: 1,001 screws (89%) were placed robotically, 63 (6%) were converted from robotic placement to a freehand technique, and 59 (5%) were planned to be implanted freehand. Of the robotically placed screws, 942 screws (94%) were determined to be Gertzbein and Robbins grade A with median deviation of 0.8 mm (interquartile range 0.4 to 1.6). Skive events were noted with 20 pedicle screws (1.8%). No adverse clinical sequelae were noted in the 90-day follow-up. The mean fluoroscopic exposure per screw was 4.9 seconds (SD 3.8). RNA is highly accurate and reliable, with a low rate of abandonment once mastered. No adverse clinical sequelae occurred after implanting a large series of pedicle screws using the latest generation of RNA. Understanding of patient-specific anatomical features and the real-time intraoperative identification of risk factors for suboptimal screw placement have the potential to improve accuracy further., Competing Interests: None declared., (© 2023 The British Editorial Society of Bone & Joint Surgery.)
- Published
- 2023
- Full Text
- View/download PDF
14. Background, techniques, applications, current trends, and future directions of minimally invasive endoscopic spine surgery: A review of literature.
- Author
-
Tang K, Goldman S, Avrumova F, and Lebl DR
- Abstract
Across many of the surgical specialties, the use of minimally invasive techniques that utilize indirect visualization has been increasingly replacing traditional techniques which utilize direct visualization. Arthroscopic surgery of the appendicular skeleton has evolved dramatically and become an integral part of musculoskeletal surgery over the last several decades, allowing surgeons to achieve similar or better outcomes, while reducing cost and recovery time. However, to date, the axial skeleton, with its close proximity to critical neural and vascular structures, has not adopted endoscopic techniques at as rapid of a rate. Over the past decade, increased patient demand for less invasive spine surgery combined with surgeon desire to meet these demands has driven significant evolution and innovation in endoscopic spine surgery. In addition, there has been an enormous advancement in technologies that assist in navigation and automation that help surgeons circumvent limitations of direct visualization inherent to less invasive techniques. There are currently a multitude of endoscopic techniques and approaches that can be utilized in the treatment of spine disorders, many of which are evolving rapidly. Here we present a review of the field of endoscopic spine surgery, including the background, techniques, applications, current trends, and future directions, to help providers gain a better understanding of this growing modality in spine surgery., Competing Interests: Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article., (©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
15. Augmented reality for minimally invasive spinal surgery.
- Author
-
Avrumova F and Lebl DR
- Abstract
Background: Augmented reality (AR) is an emerging technology that can overlay computer graphics onto the real world and enhance visual feedback from information systems. Within the past several decades, innovations related to AR have been integrated into our daily lives; however, its application in medicine, specifically in minimally invasive spine surgery (MISS), may be most important to understand. AR navigation provides auditory and haptic feedback, which can further enhance surgeons' capabilities and improve safety., Purpose: The purpose of this article is to address previous and current applications of AR, AR in MISS, limitations of today's technology, and future areas of innovation., Methods: A literature review related to applications of AR technology in previous and current generations was conducted., Results: AR systems have been implemented for treatments related to spinal surgeries in recent years, and AR may be an alternative to current approaches such as traditional navigation, robotically assisted navigation, fluoroscopic guidance, and free hand. As AR is capable of projecting patient anatomy directly on the surgical field, it can eliminate concern for surgeon attention shift from the surgical field to navigated remote screens, line-of-sight interruption, and cumulative radiation exposure as the demand for MISS increases., Conclusion: AR is a novel technology that can improve spinal surgery, and limitations will likely have a great impact on future technology., Competing Interests: DRL receives royalties and is a consultant with Stryker; receives royalties from NuVasive; is a consultant with Depuy Synthes; is on the advisory board and has an ownership interest with Remedy Logic; is a consultant and has an ownership interest with Viseon, Inc.; and has an ownership interest with Woven Orthopedic Technologies, and Research Support from Medtronic; is consulstant and on the advisory board for Choice Spine, Vestia Ventures MiRus Investment LLC, ISPH II LLC, and HS2 LLC. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Avrumova and Lebl.)
- Published
- 2023
- Full Text
- View/download PDF
16. Cervical Spine Navigation and Enabled Robotics: A New Frontier in Minimally Invasive Surgery.
- Author
-
Lebl DR, Avrumova F, Abjornson C, and Cammisa FP
- Abstract
Background : Robotic-assisted and computer-assisted navigation (CAN) systems utilization has been rapidly increasing in recent years. Most existing data using these systems are performed in the thoracic, lumbar, and sacral spine. The unique anatomy of the cervical spine maybe where these technologies have the greatest potential. To date, the role of navigation-enabled robotics in the cervical spine remains in its early stages of development and study. Purpose : This review article describes the early experience, case descriptions and technical considerations with cervical spine screw fixation and decompression using CAN and robotic-assisted surgery. Methods : Representative cervical cases with early surgical experience with cervical and robotic assisted surgery with CAN. Surgical set up, technique considerations, instrumentation, screw accuracy and screw placement were elevated and recorded for each representative cervical case. Results : Existing robotic assisted spine surgical systems are reviewed as they pertain to the cervical spine. Method for cervical reference and positioning on radiolucent Mayfield tongs are presented. C1 lateral mass, odontoid fracture fixation, C2 pedicle, translaminar, subaxial lateral mass, mid cervical pedicle, navigated decompression and ACDF cases and techniques are presented. Conclusion : In conclusion, within the last several years, the use of CANs in spinal surgery has grown and the cervical spine shows the greatest potential. Several robotic systems have had FDA clearance for use in the spine, but such use requires simultaneous intraoperative fluoroscopic confirmation. In the coming years, this recommendation will likely be dropped as accuracy improves., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DRL reports relationships with Medtronic, NuVasive, Stryker, Depuy Synthes, Guidepoint, Remedy Logic, ISPH II, Vestia Ventures, MiRUS, Woven Orthopedic Technologies, Integrity Implants, and HS2. CA reports relationships with Orthobond Corporation, Camber Spine Tech, SpineBioPharma, Centinel Spine, and RTI Surgical. FPC reports relationships with 4WEB Medical, 7D Surgical, Centinel Spine, Malinckrodt Pharmaceuticals, NuVasive, RTI Surgical, Pfizer, Orthofix Medical, HealthPoint Capital Partners, Orthobond Corporation, Woven Orthopedic Technologies, Bonovo Orthopedics, ISPH II, Ivy Capital Partners, Liventa BioScience, Medical Device Partners III, Tissue Differentiation Intelligence, VBVP VI, Vertical Spine, and Viscogliosi Brothers. FA reports no potential conflicts of interests., (© The Author(s) 2021.)
- Published
- 2021
- Full Text
- View/download PDF
17. Comparing the Efficacy of Radiation Free Machine-Vision Image-Guided Surgery With Traditional 2-Dimensional Fluoroscopy: A Randomized, Single-Center Study.
- Author
-
Dorilio J, Utah N, Dowe C, Avrumova F, Alicea D, Brecevich A, Callanan T, Sama A, Lebl DR, Abjornson C, and Cammisa FP
- Abstract
Background: Three-dimensional (3D) computer-assisted navigation (CAN) has emerged as a potential alternative to 2-dimensional (2D) fluoroscopy in the surgical placement of spinal instrumentation. Recently, 3D-CAN systems have improved significantly in their ability to provide real-time anatomical referencing while shortening the registration and set-up time. A novel system in navigation, Machine-Vision Image-Guided Surgery (MvIGS; 7D Surgical, Toronto, Canada) was cleared by the US Food and Drug Administration, but its potential benefits in reducing intra-operative radiation exposure to patients and enhancing surgical accuracy of pedicle screw placement are not fully known. Purpose : We sought to conduct a prospective, randomized, clinical study comparing the 3D-MvIGS spinal navigation system and 2D-fluoroscopy for pedicle screw insertion up to 3 levels (T10-S1) and for various measures of surgical efficacy. Methods : Sixty-two eligible patients were randomized to receive spine surgery using either the 3D-MvIGS group or the conventional 2D-fluoroscopy for pedicle screw fixation for the treatment of spinal stenosis and degenerative spondylolisthesis. Intra-operative parameters and procedure-related unintended protocol violations were recorded. Results : Operative time and estimated blood loss were not significantly different between groups. Radiation time and exposure to patients were significantly reduced in the 3D-MvIGS group. There was no difference between groups in pedicle screw placement accuracy (2D-fluoroscopy group, 96.6%; 3D-MvIGS group, 94.2%). There were no major complications or cases that required revision surgery. Conclusion : The 3D-MvIGS navigation system performed comparably with 2D-fluoroscopy in terms of pedicle screw placement accuracy and operative time. The 3D-MvIGS showed a significant reduction in radiation exposure to patients. In more complex cases or larger cohorts, the true value of greater anatomical visualization can be elucidated., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Andrew Sama, MD, reports relationships with Ortho Development Corp., South Carolina Spine Society, Clariance, Inc., DePuy Synthes, Kuros Biosciences, Integrity Implants, Ortho Development Corp., Orthofix (formerly Spinal Kinetics), Paradigm Spine, LLC, Vestia Ventures, and MiRus Investment, LLC. Darren R. Lebl, MD, reports relationships with Medtronic, Time, Nuvasive, Inc., Stryker, DePuy Synthes, Guidepoint, Remedy Logic, ISPH II, LLC, Vestia Ventures, MiRUS LLC, Woven Orthopedic Technologies, and Integrity Implants, LLC. Celeste Abjornson, PhD, reports relationships with Camber Spine Tech, Centinel Spine, Inc., RTI Surgical, Inc., and Orthobond Corporation. Frank P. Cammisa, MD, reports relationships with 7D Surgical, Inc., 4WEB Medical, Centinel Spine, Inc. (Formerly Cell Medica), Mallinckrodt Pharmaceuticals, NuVasive, Inc., RTI Surgical Inc. (formerly Paradigm Spine, LLC), Pfizer, Inc., Orthofix Medical Inc. (formerly Spinal Kinetics, Inc.), HealthPoint Capital Partners, LP, Orthobond Corporation, Orthofix Medical Inc. (formerly Spinal Kinetics, Inc.), Woven Orthopedic Technologies, Bonovo Orthopedics, Inc., Ivy Capital Partners LLC, Liventa BioScience, Inc., Medical Device Partners III, LLC, Tissue Differentiation Intelligence, LLC, VBVP VI, LLC (formerly Centinel Spine, Inc.), Vertical Spine, LLC, and Viscogliosi Brothers, LLC. The other authors declare no potential conflicts of interest., (© The Author(s) 2021.)
- Published
- 2021
- Full Text
- View/download PDF
18. Overview of Robotic Technology in Spine Surgery.
- Author
-
Alluri RK, Avrumova F, Sivaganesan A, Vaishnav AS, Lebl DR, and Qureshi SA
- Abstract
As robotics in spine surgery has progressed over the past 2 decades, studies have shown mixed results on its clinical outcomes and economic impact. In this review, we highlight the evolution of robotic technology over the past 30 years, discussing early limitations and failures. We provide an overview of the history and evolution of currently available spinal robotic platforms and compare and contrast the available features of each. We conclude by summarizing the literature on robotic instrumentation accuracy in pedicle screw placement and clinical outcomes such as complication rates and briefly discuss the future of robotic spine surgery., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Darren R. Lebl, MD, reports relationships with Medtronic, Nuvasive, Stryker, Depuy Synthes, Guidepoint, Remedy Logic, ISPH II, Vestia Ventures, MiRUS, Woven Orthopedic Technologies, Integrity Implants, and HS2. Sheeraz A. Qureshi, MD, MBA, reports relationships with Stryker K2M, Globus Medical, Paradigm Spine, AMOpportunities, RTI Surgical, Integrity Implants, Medical Device Business Services, Medtronic USA, Nuvasive, Avaz Surgical, Simplify Medical, Tissue Differentiation Intelligence, Vital 5, Spinal Simplicity, LifeLink.com, Healthgrades, Society of Minimally Invasive Spine Surgery, Simplify Medical, North American Spine Society, Minimally Invasive Spine Study Group, Lumbar Spine Research Society, International Society for the Advancement of Spine Surgery, Contemporary Spine Surgery, Cervical Spine Research Society, Association of Bone and Joint Surgeons, and Annals of Translational Medicine. Ram K. Alluri, MD, Fedan Avrumova, BS, Ahilan Sivaganesan, MD, and Avani S. Vaishnav, MBBS, declare no potential conflicts of interest., (© The Author(s) 2021.)
- Published
- 2021
- Full Text
- View/download PDF
19. Workflow and Efficiency of Robotic-Assisted Navigation in Spine Surgery.
- Author
-
Avrumova F, Sivaganesan A, Alluri RK, Vaishnav A, Qureshi S, and Lebl DR
- Abstract
Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Darren R. Lebl, MD, reports relationships with Medtronic, Nuvasive, Stryker, Depuy Synthes, Guidepoint, Remedy Logic, ISPH II, Vestia Ventures, MiRUS, Woven Orthopedic Technologies, Integrity Implants, and HS2. Sheeraz Qureshi, MD, reports relationships with Stryker K2M, Globus Medical, Paradigm Spine, AMOpportunities, RTI Surgical, Integrity Implants, Medical Device Business Services, Medtronic USA, Nuvasive, Speakers’ Bureau, Avaz Surgical, Simplify Medical, Tissue Differentiation Intelligence, Vital 5, Spinal Simplicity, LifeLink.com, Healthgrades, Society of Minimally Invasive Spine Surgery, Simplify Medical, North American Spine Society, Minimally Invasive Spine Study Group, Lumbar Spine Research Society, International Society for the Advancement of Spine Surgery, Contemporary Spine Surgery, Cervical Spine Research Society, Association of Bone and Joint Surgeons, and Annals of Translational Medicine. Fedan Avrumova, BS, Ahilan Sivaganesan, MD, Kiran Alluri, MD, and Avani Vaishnav, MD, declare no potential conflicts of interests.
- Published
- 2021
- Full Text
- View/download PDF
20. Comprehensive Error Analysis for Robotic-assisted Placement of Pedicle Screws in Pediatric Spinal Deformity: The Initial Learning Curve.
- Author
-
Morse KW, Heath M, Avrumova F, Defrancesco C, Fabricant PD, Lebl DR, and Widmann RF
- Abstract
Background: Surgical navigation improves pedicle screw insertion accuracy and reliability. Robotic-assisted spinal surgery and screw placement has not been fully assessed in pediatric patients with spine deformity undergoing posterior spinal fusion. The purpose of this study was to describe the learning curve for robotically assisted pedicle screw placement in pediatric patients., Methods: A retrospective review on a consecutive series of the first 19 pediatric patients who underwent posterior spinal fusion by a single surgeon using robotic navigation was performed. Demographics, curve parameters, pedicle diameter, vertebral rotation, and additional outcome measures were recorded. Screw position was assessed with calibrated intraoperative 3-dimensional fluoroscopic images. All complications of planned and placed robotically placed screws were recorded., Results: A total of 194 left-sided screws were planned as robot-assisted. One hundred sixty-eight of the robotically planned screws (86.6%) were placed with robot assistance; 29 robotically planned screws (15.0%) were abandoned or converted to freehand. The mean time per robotically placed screw was 3.6±2.4 minutes. Fifteen breaches (8.9%) and 1 anterior perforation occurred with 2 critical (>2 to 4 mm) breaches, 1 was associated with a durotomy, and both occurred in the first case. There were no intraoperative/postoperative neuromonitoring changes and no sequela from the durotomy. Six breaches occurred in the first case. The odds ratio of obtaining a breach in screws with a matched trajectory was 0.275 (95% confidence interval: 0.089-0.848)., Conclusions: Screw time and accuracy improved and the number of breaches decreased after 10 cases. This series had 2 critical breaches (between 2 and 4 mm) on the first case. Overall, excluding the 2 critical breaches, 98.8% of robotically executed screws were placed without a critical breach, which is comparable to previous pediatric deformity studies. Caution should be exercised during the initial training period to avoid complications as experience and training lead to an improved understanding of surgical planning, skive, and soft-tissue pressure on the end-effector all of which can impact accuracy of robotically assisted pedicle screw placement., Level of Evidence: Case Series, IV., Competing Interests: D.R.L. and R.F.W. are consultants for Medtronic and they were not paid for their involvement in this study, which may result in a potential conflict of interest bias. However, the retrospective nature of the study resulted in independent researchers conducting independent data analysis and manuscript writing limits this potential for bias. One author has a consulting fee range of $1.00 to $ 10,000 (B) and the second has not received any compensation for research, education or consulting. The remaining authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
21. Evaluation of K-wireless robotic and navigation assisted pedicle screw placement in adult degenerative spinal surgery: learning curve and technical notes.
- Author
-
Avrumova F, Morse KW, Heath M, Widmann RF, and Lebl DR
- Abstract
Background: K-wireless robotic pedicle screw instrumentation with navigation is a new technology with large potential. Barriers to adoption are added registration time with robotic-navigated system and reliable screw positioning. Understanding the learning curve and limitations is crucial for successful implementation. The purpose of this study was to describe a learning curve of k-wireless robotic assisted pedicle screw placement with navigation and compare to conventional techniques., Methods: A retrospective review of prospectively collected data of 65 consecutive adult patients underwent robotic-navigated posterior spinal fusion by a single spine surgeon. Registration, screw placement, and positioning times were recorded. All patients underwent intra-operative 3D fluoroscopy and screw trajectory was compared to pre-operative CT., Results: A total of 364 instrumented pedicles were planned robotically, 311 (85.4%) were placed robotically; 17 screws (4.7%) converted to k-wire, 21 (5.8%) converted to freehand, and 15 (4.1%) planned freehand. Of the 311 robotically placed pedicle screws, three dimensional fluoroscopic imaging showed 291 (93.5%) to be GRS Grade A in the axial plane (fully contained within the pedicle) and 281 (90.4%) were GRS Grade A in the sagittal plane. All breached screw deviations from plan were identified on 3D fluoroscopy during surgery and repositioned and confirmed by additional 3d fluoroscopy scan. Reasons for conversion included morphology of starting point (n=18), soft tissue pressure (n=9), hypoplastic pedicles (n=6), obstructive reference pin placement (n=2), and robotic arm issues (n=1). Seventeen (5.5%) critical breaches (≥2-4 mm) were recorded in 11 patients, 9 (2.9%) critical breaches were due to soft tissue pressure causing skive. Two patients experienced 6 (1.9%) critical breaches from hypoplastic pedicles, and 3 (0.9%) unplanned lateral breaches were found in another patient. One patient (0.3%) experienced skive due to morphology and spinal instability from isthmic spondylolisthesis. Imaging showed 143 screws placed medially to plan (1.2±0.9 mm), 170 lateral (1.2±1.1 mm), 193 screws caudal (1.0±0.6 mm) and 117 cranial (0.6±0.5 mm). No adverse clinical sequelae occurred from implantation of any screw., Conclusions: The learning curve showed improvement in screw times for the first several cases. Understanding the learning curve and situations where the robotic technique may be suboptimal can help guide the surgeon safe and effectively for adoption, as well as further refine these technologies., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/jss-20-687). DRL reports research support from Medtronic, during the conduct of the study; royalties from K2M- Stryker, royalties from NuVasive, ownership interest from Woven Orthopedic Technologies, ownership interest from Vestia Ventures MiRus Investment LLC, investment interest from ISPH II, LLC, outside the submitted work. RFW reports personal fees from Medtronic, outside the submitted work, and fee for Service Consultant to OrthoPediatric Company Spine Division. RFM is on the editorial board Spine Deformity Journal, editorial board of The Journal of Children’s Orthopaedics, and a consultant reviewer for the Journal of Pediatric Orthopaedics. The other authors have no conflicts of interests to declare., (2021 Journal of Spine Surgery. All rights reserved.)
- Published
- 2021
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.