Mazor Robotics technology has been successfully used in the placement of over 160,000 implants in the United States, Asia and Europe. Numerous peer-reviewed publications and presentations at leading scientific conferences have validated the accuracy, usability, and clinical advantages of spine surgery with Mazor Robotics technology.
Below is a listing of all published clinical evidence that supports the use of Mazor Robotics technology in spine surgery. Please visit The National Library of Medicine for complete, full-text articles.
Authors : Macke JJ, Woo R, Varich L
Accuracy of robot-assisted pedicle screw placement for adolescent idiopathic scoliosis in the pediatric population. : Journal of Robotic Surgery
Authors : Granit Molliqaj, MD, Bawarjan Schatlo, MD, Awad Alaid, MD, Volodymyr Solomiichuk, MD, Veit Rohde, MD, Karl Schaller, MD, and Enrico Tessitore, MD
Accuracy of robot-guided versus freehand fluoroscopy-assisted pedicle screw insertion in thoracolumbar spinal surgery : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Authors : Karthik Madhavan, MD, John Paul G. Kolcun, BS, Lee Onn Chieng, BS, and Michael Y. Wang, MD
Augmented-reality integrated robotics in neurosurgery: are we there yet? : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Authors : Jacob R. Joseph, MD, Brandon W. Smith, MD, Xilin Liu, MD, and Paul Park, MD
Current applications of robotics in spine surgery: a systematic review of the literature : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Authors : Naureen Keric, MD, Christian Doenitz, MD, Amer Haj, MD, Izabela Rachwal-Czyzewicz, MD, Mirjam Renovanz, MD, Dominik M. A. Wesp, MD, Stephan Boor, MD, Jens Conrad, MD, Alexander Brawanski, MD, Alf Giese, MD, and Sven R. Kantelhardt, MD
Evaluation of robot-guided minimally invasive implantation of 2067 pedicle screws : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Authors : Timur M. Urakov, MD, Ken Hsuan-kan Chang, MD, S. Shelby Burks, MD, and Michael Y. Wang, MD
Initial academic experience and learning curve with robotic spine instrumentation : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Authors : Marc L. Schröder, MD, PhD, and Victor E. Staartjes
Revisions for screw malposition and clinical outcomes after robot-guided lumbar fusion for spondylolisthesis : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Author: Volodymyr Solomiichuk, MD, Julius Fleischhammer, MD, Granit Molliqaj, MD, Jwad Warda, MD, Awad Alaid, MD, Kajetan von Eckardstein, MD, Karl Schaller, MD, Enrico Tessitore, MD, Veit Rohde, MD, and Bawarjan Schatlo, MD
Robotic versus fluoroscopy-guided pedicle screw insertion for metastatic spinal disease: a matched-cohort comparison. : Journal of Neurosurgery 2017 (Neurosurgical Focus)
Author: Hyun SJ, Kim KJ, Jahng TA.
S2 alar iliac screw placement under robotic guidance for adult spinal deformity patients: technical note. Eur Spine J. 2017 [Epub ahead of print.
PURPOSE. S2 alar-iliac (S2AI) screws are generally placed using an open approach, but have recently been shown to be implantable using a minimally invasive approach. Nevertheless, optimal screw positioning, even when supported by fluoroscopic guidance, is challenging in the complex anatomy of the sacral-pelvic area. This work presents our novel technique of S2AI sacropelvic fixation procedures performed with robotic guidance.
METHODS. This was a single-center, retrospective, mini case-series of adult spinal deformity patients in need of sacropelvic fixation as part of a longer thoraco-lumbar fusion. The surgeon drilled a pilot hole through a robotic guide and then inserted a K-wire. A Jamshidi needle was placed over the K-wire and used to advance the pilot hole anterolaterally.
RESULTS.Medical charts of four 60-70 year-old patients, who underwent robotic-guided insertion of S2AI screws in a minimally invasive approach were reviewed. Follow-up ranged between 10 and 13 months. Post-operative CTs and X-rays showed all eight trajectories were fully within the bone and accurately placed. Average surgery time per patient was 13 min with 5.3 s of fluoroscopy per screw. No intra- or post-operative complications occurred.
CONCLUSIONS. Robotic-guidance with a Jamshidi needle technique was a safe and effective means for implanting S2AI screws in a minimally invasive approach.
Author: Keric N, Eum DJ, Afghanyar F, et al.
Evaluation of surgical strategy of conventional vs. percutaneous robot-assisted spinal trans-pedicular instrumentation in spondylodiscitis. J Robotic Surg.
Author: Hu X, Lieberman IH.
Robotic-guided sacro-pelvic fixation using S2 alar-iliac screws: feasibility and accuracy. Eur Spine J
Author: Kim HJ, Kang KT, Park SC et al.
Biomechanical advantages of robot-assisted pedicle screw fixation in posterior lumbar interbody fusion compared to free-hand technique in a prospective randomized controlled trial – perspective for patient-specific finite element analysis. Spine J.
Author: Amr AN, Giese A, Kantelhardt SR.
Navigation and robot-aided surgery in the spine: historical review and state of the art. Robotic Surg Rsrch Reviews.
Author: Hyun SJ, Kim KJ, Jahng TA, Kim HJ.
Minimally Invasive, Robotic-vs. Open Fluoroscopic-guided Spinal Instrumented Fusions-a Randomized, Controlled Trial. Spine.
Author: Kim HJ, Jung WI, Chang BS et al.
A prospective, randomized, controlled trial of robot‐assisted vs. freehand pedicle screw fixation in spine surgery. Int J Med Robotics Comput Assist Surg.
Author: Tsai TH, Wu DS, Su YF, et al.
A retrospective study to validate an intraoperative robotic classification system for assessing the accuracy of kirschner wire (K-wire) placements with postoperative computed tomography classification system for assessing the accuracy of pedicle screw placements. Medicine.
Author: Minfeng G, Huilin Y, Feng Z.
Accuracy of robot-assisted pedicle screws placement. Chin J Anat Clin.
Author:Bederman SS, Hahn P, Colin V, Kiester, PD, Bhatia NN.
Robotic Guidance for S2-Alar-Iliac Screws in Spinal Deformity Correction. J Spinal Disord Tech.
Author: Bederman SS, Hahn P, Colin V, et al.
Robotic Guidance for S2-Alar-Iliac Screws in Spinal Deformity Correction. J Spinal Disord Tech.
Author: Liu H, Chen W, Wang Z, et al.
Comparison of the accuracy between robot-assisted and conventional freehand pedicle screw placement: a systematic review and meta-analysis. Int J Comput Assist Radiol Surg.
Author: Seung-Jae Hyun, Ki-Jeong Kim, Tae-Ahn Jahng, Hyun-Jib Kim.
Background. Despite the firmly established occupational risk of exposure to X-rays, they are used extensively in spine surgeries. Shielding by lead aprons is the most common protective practice. We quantified the level of their radiation blocking ability in a real-life setting.
Methods. Single-center, prospective, randomized study of adult patients with degenerative lumbar disorders, scheduled to undergo posterior lumbar interbody fusion. Instrumentation was performed in either a robot-assisted, minimally invasive approach (RO) or a conventional, fluoroscopically-assisted, open approach (FA). Outcome measures included the quantitative measurement of the surgeon’s actual exposure to radiation, as recorded by thermo-luminescent dosimeters (TLD) worn both above and under the 0.5 mm thyroid and trunk lead protectors.
Findings. Sixty four patients were included in this study, 34 in the RO cohort and 30 in the FA cohort. The radiation blocked by the aprons, represented as the ratio of the under-apron to above-apron TLDs, averaged 37.1% (range 25.4–48.3%, 95% confidence interval between 30.6–43.6%). In the RO cohort, the average per-screw radiation dose and time were 51.9% and 73.7% lower, respectively, than the per screw exposure in the FA cohort.
Interpretation. The 0.5 mm lead aprons blocked just over one third of the radiation scattered towards the surgeon. Use of robotic-guidance in a minimally invasive approach provided for a reduction of 62.5% of the overall radiation the surgeon was exposed to during open conventional approach. We conclude that reduced radiation use (e.g. by using robotic guidance) is a more effective strategy for minimizing exposure to radiation than reliance on protection by lead aprons, and recommend utilization of practices and technologies that reduce the surgical team’s routine exposure to X-rays.
Author: Keng-Liang Kuo Et al.
Introduction. Pedicle screws are commonly employed to restore spinal stability and correct deformities. The Renaissance robotic system was developed to improve the accuracy of pedicle screw placement.
Purpose. In this study, we developed an intraoperative classification system for evaluating the accu- racy of pedicle screw placements through secondary registration. Furthermore, we evalu- ated the benefits of using the Renaissance robotic system in pedicle screw placement and postoperative evaluations. Finally, we examined the factors affecting the accuracy of pedi- cle screw implantation.
Results. Through use of the Renaissance robotic system, the accuracy of Kirschner-wire (K-wire) placements deviating < 3 mm from the planned trajectory was determined to be 98.74%. According to our classification system, the robot-guided pedicle screw implantation attained an accuracy of 94.00% before repositioning and 98.74% after repositioning. However, the malposition rate before repositioning was 5.99%; among these placements, 4.73% were immediately repositioned using the robot system and 1.26% were manually repositioned after a failed robot repositioning attempt. Most K-wire entry points deviated caudally and laterally.
Conclusion. The Renaissance robotic system offers high accuracy in pedicle screw placement. Second- ary registration improves the accuracy through increasing the precision of the positioning.
Author: Fujishiro, Takashi MD Et al.
Study Design. A cadaveric study.
Objective. To investigate the accuracy of pedicle screw placement using a robotic guidance system (RGS).
Summary of Background Data. RGS is a unique surgery assistance-apparatus. Although several clinical studies have demonstrated that RGS provides accurate pedicle screw placement, very few studies have validated its accuracy.
Methods. A total of 216 trajectories performed with the assistance of the RGS in eight cadavers were evaluated. The RGS was used, with different mounting platforms, to drill pilot holes in the thoracic and lumbosacral spine, using 3-mm diameter fiducial wires as trajectory markers. Deviation between the preoperative plan and executed trajectories was measured at the entry points to the vertebrae and at a depth of 30 mm along the wire. Both the deviation from the preoperative plan and the wire position were evaluated in the axial and sagittal planes using computed tomography (CT).
Results. The average deviation from the planned wire placement was 0.64 ± 0.59 mm at the entry point and 0.63 ± 0.57 mm at a depth of 30 mm in the axial plane, and 0.77 ± 0.62 mm and 0.80 ± 0.66 mm, respectively, in the sagittal plane. The magnitude of deviation was not affected by the vertebral level or the platform used. The use of an open approach achieved greater screw placement accuracy at a depth of 30 mm in the sagittal plane, compared with the percutaneous approach. The fiducials were placed completely within the pedicle in 93.9% of trajectories in the axial plane (n = 164 pedicles with a width ≥5 mm) and 98.6% in the sagittal plane (n = 216).
Conclusion. In this cadaveric study, RGS supported execution of accurate trajectories that were equal or slightly superior to reports of CT-based navigation systems.
Author: Grimm F, Naros G Et al.
Frame-based stereotactic interventions are considered the gold standard for brain biopsies, but they have limitations with regard to flexibility and patient comfort because of the bulky head ring attached to the patient. Frameless image guidance systems that use scalp fiducial markers offer more flexibility and patient comfort but provide less stability and accuracy during drilling and biopsy needle positioning. Head-mounted robot-guided biopsies could provide the advantages of these 2 techniques without the downsides. The goal of this study was to evaluate the feasibility and safety of a robotic guidance device, affixed to the patient's skull through a small mounting platform, for use in brain biopsy procedures.
This was a retrospective study of 37 consecutive patients who presented with supratentorial lesions and underwent brain biopsy procedures in which a surgical guidance robot was used to determine clinical outcomes and technical procedural operability.
The portable head-mounted device was well tolerated by the patients and enabled stable drilling and needle positioning during surgery. Flexible adjustments of predefined paths and selection of new trajectories were successfully performed intraoperatively without the need for manual settings and fixations. The patients experienced no permanent deficits or infections after surgery.
The head-mounted robot-guided approach presented here combines the stability of a bone-mounted set-up with the flexibility and tolerability of frameless systems. By reducing human interference (i.e., manual parameter settings, calibrations, and adjustments), this technology might be particularly useful in neurosurgical interventions that necessitate multiple trajectories.
Authors : Schatlo B, Martinez R, Alaid A, et al.
Unskilled unawareness and the learning curve in robotic spine surgery. : Acta Neurochir 2015;157(10):1819-23
Author: Van Dijk JD Et al.
A retrospective chart review was performed for 112 consecutive minimally invasive spinal surgery patients who underwent pedicular screw fixation in a community hospital setting.
To assess the clinical accuracy and deviation in screw positions in robot-assisted pedicle screw placement.
SUMMARY OF BACKGROUND DATA:
Accuracy of pedicle screw placement in in vivo studies varies widely, especially when minimally invasive techniques are used. Robotic guidance was recently introduced to increase screw placement accuracy but still reported accuracies vary.
Reproducibility of the surgeon's plan using robotic guidance was assessed by fusing individual vertebras from the preoperative computed tomography (CT) containing the planning with a postoperative CT. Deviation in entry point and difference in angle of insertion was measured on axial and sagittal planes. Grading of pedicle screw placement was performed on postoperative CTs using the Gertzbein-Robbins classification.
CT-to-CT fusion succeeded for 178 screws, but these appeared to be random, with no apparent selection bias. Mean deviation in entry point was 2.0 ± 1.2 mm. Mean difference in angle of insertion was 2.2° ± 1.7° on the axial plane and 2.9° ± 2.4° on the sagittal plane. Assessment of pedicle screw accuracy showed that 477 of 487 screws (97.9%) were safely placed (
Preoperative planning of robotic guidance is reproduced intraoperatively within acceptable deviations. We conclude that robotic guidance allows for highly accurate execution of the preoperative plan, leading to accurate screw placement.
LEVEL OF EVIDENCE:3.
Author: Kim, Ho-Joong MD Et al.
Study Design. Prospective randomized controlled trial.
Objective. The aim of this study was to monitor the quality control of robot-assisted pedicle screw fixation accuracy by using a cumulative summation (CUSUM) test at the initial stage of its application.
Summary of Background Data. Although robot-assisted pedicle screw fixation reduces screw misplacement rates and provides critical support for minimally invasive surgical procedures, there have been no reports relating to the monitoring of quality control of the accuracy of this robot-assisted pedicle screw fixation procedure.
Methods. Patients with lumbar spinal stenosis scheduled to undergo surgery were randomly and equally assigned through 1:1 allocation to a robot-assisted minimally invasive posterior lumbar interbody fusion (Rom-PLIF) group or a conventional open posterior PLIF using freehand technique group. The accuracy of pedicle screw placement was evaluated using postoperative computed tomography. The primary outcome was the CUSUM analysis for monitoring the quality control of the accuracy of pedicle screw insertion between the Rom-PLIF and conventional open posterior PLIF using freehand technique groups.
Results. Of the 80 pedicle screws inserted in each group, 4 screws in the Rom-PLIF group, and 7 in the conventional open PLIF group, breached the pedicle. Of these 11 offending screws, 4 cases were categorized as grade B in the Rom-PLIF group, whereas 6 were grade B and 1 case was grade C in the Com-PLIF group, using the Gertzbein and Robbins classification. Throughout the monitoring period, there was no CUSUM test-derived indication that the quality of performance of the pedicle screw fixation procedure was inadequate in either group.
Conclusion. First, this study demonstrates the adequacy of quality control of robot-assisted pedicle screw fixation even early in the application period based on the CUSUM analysis. Second, the CUSUM test can be a useful tool for monitoring of the quality of procedures related with spine surgery.
Level of Evidence: 2
Authors : Schatlo B, Molliqaj G, Cuvinciuc V, et al.
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):636-43
Authors : Bederman SS1, Lopez G, Ji T, Hoang BH.
Robotic guidance for en bloc sacrectomy: a case report : Spine 2014;39(23):E1398-401
Authors : Kantelhardt SR, Keric N, Conrad J, et al.
C-OnSite® for intraoperative 3D control of pedicular screw positions : Acta Neurochir 2014;156(9):1799-805
Author: Mehet Resid ONEN Et al.
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Authors : Onen MR, Simsek M, Naderi S.
Robotic Assisted Sacroplasty: A Case Report. : Turkish Neurosurgery 2014 24(4):574-578
Author: Barzilay, Yair MD; Schroeder Et al.
Study Design. Retrospective.
Objective. To assess radiation exposure time during robot-guided vertebral body augmentation compared with other published findings.
Summary of Background Data. Rising incidence of vertebral compression fractures in the aging population result in widespread use of vertebral body cement augmentation with significant radiation exposure to the surgeon, operating room staff, and patient. Radiation exposure leads to higher cancer rates among orthopedic and spine surgeons and patients.
Methods. Thirty-three patients with 60 vertebral compression fractures underwent robot-guided vertebral body augmentation performed by 2 surgeons simultaneously injecting cement at 2 levels under pulsed fluoroscopy. The age of patients was in the range from 29 to 92 (mean, 67 yr). One to 6 vertebrae were augmented per case (average 2). Twenty-five patients had osteoporotic fractures and 8 had pathological fractures. Robotic guidance data included execution rate, accuracy of guidance, total surgical time, and time required for robotic guidance. Radiation-related data included the average preoperative computed tomographic effective dose, radiation time for calibration, registration, placement of Kirschner wires, and total procedure radiation time. Radiation time per level and surgeon's exposure were calculated.
Results. Kyphoplasty was performed in 15 patients (1 sacroplasty), vertebroplasty in 13, and intravertebral expanding implants in 5. The average preoperative computed tomographic effective dose was 50 mSv (18–81). Average operative time was 118 minutes (49–350). Mean robotic guidance took 36 minutes. Average operative radiation time was 46.1 seconds per level (33–160). Average exposure time of the surgeons and the operating room staff per augmented level was 37.6 seconds. The execution rate was 99%, with an accuracy of 99%. Two complications (hemothorax and superficial wound infection) occurred.
Conclusion. The radiation exposure of the surgeon and the operating room staff in a series of robot-assisted vertebral body augmentation was 74% lower than published results on fluoroscopy guidance and approximately 50% lower than the literature on navigated augmentation.
Level of Evidence: 4
Author: Xiaobang Hu Et al.
Some early studies with robotic-assisted pedicle screw implantation have suggested these systems increase accuracy of screw placement. However, the relationship between the success rate of screw placement and the learning curve of this new technique has not been evaluated.
We determined whether, as a function of surgeon experience, (1) the success rate of robotic-assisted pedicle screw placement improved, (2) the frequency of conversion from robotic to manual screw placement decreased, and (3) the frequency of malpositioned screws decreased.
Between June 2010 and August 2012, the senior surgeon (IHL) performed 174 posterior spinal procedures using pedicle screws, 162 of which were attempted with robotic assistance. The use of the robotic system was aborted in 12 of the 162 procedures due to technical issues (registration failure, software crash, etc). The robotic system was successfully used in the remaining 150 procedures. These were the first procedures performed with the robot by the senior surgeon, and in this study, we divided the early learning curve into five groups: Group 1 (Patients 1–30), Group 2 (Patients 31–60), Group 3 (Patients 61–90), Group 4 (Patients 91–120), and Group 5 (Patients 121–150). One hundred twelve patients (75%) had spinal deformity and 80 patients (53%) had previous spine surgery. The accuracy of screw placement in the groups was assessed based on intraoperative biplanar fluoroscopy and postoperative radiographs. The results from these five groups were compared to determine the effect on the learning curve. The numbers of attempted pedicle screw placements were 359, 312, 349, 359, and 320 in Groups 1 to 5, respectively.
The rates of successfully placed screws using robotic guidance were 82%, 93%, 91%, 95%, and 93% in Groups 1 to 5. The rates of screws converted to manual placement were 17%, 7%, 8%, 4%, and 7%. Of the robotically placed screws, the screw malposition rates were 0.8%, 0.3%, 1.4%, 0.8%, and 0%.
The rate of successfully placed pedicle screws improved with increasing experience. The rate of the screws that were converted to manual placement decreased with increasing experience. The frequency of screw malposition was similar over the learning curve at 0% to 1.4%. Future studies will need to determine whether this finding is generalizable to others.
Level of Evidence
Level III, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.
Author:Roser F, Tatagiba M, Maier G, Spinal Robotics.
Current Applications and Future Perspectives. Neurosurgery.
Author:Marcus HJ, Cundy TP, Nandi D, Yang GZ, Darzi A.
Robot-assisted and fluoroscopy-guided pedicle screw placement: a systematic review. Eur Spine J.
Author:Hu X, Ohnmeiss D. Lieberman.
Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J.
Author:Ringel F, Stüer C, Reinke A, Preuss A, et al.
Accuracy of Robot-Assisted Placement of Lumbar and Sacral Pedicle Screws. Spine
Authors : Schizas C, Thein E, Kwiatkowski B, Kulik G.
Pedicle screw insertion : robotic assistance versus conventional C-arm fluoroscopy. : Acta Orthop. Belg., 2012, 78, 240-245
Author: Lieberman IH, Hardenbrook MA, Wang JC, Guyer RD
Assessment of Pedicle Screw Placement Accuracy, Procedure Time, and Radiation Exposure Using a Miniature Robotic Guidance System. J Spinal Disord Tech.
Author: 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.
Author: Devito DP, Kaplan L, Dietl R, Silberstein, et al.
Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine.
Authors : Birkenmaier C, Suess O, Michael Pfeiffer, et al.
The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF). : BMC Musculoskeletal Disorders
Author:Schoenmayr R, Kim I-S.
Why do I use and recommend the use of navigation? ArgoSpine News & J.
Author: Konovalov NA, Shevelev IN, Kornienko VN
Robotic assistance in spine surgery. Traumatol Orthoped Rus. (Russian language)
Author: Pechlivanis I, Kiriyanthan G, Engelhardt M, et al.
Percutaneous placement of pedicle screws in the lumbar spine using a bone mounted miniature robotic system, first experiences and accuracy of screw placement. Spine.
Author: Shoham M, Lieberman IH, Benzel EC, et al.
Robotic assisted spinal surgery – from concept to clinical practice. Computer Aided Surgery.
Author: Togawa D, Kayanja MM, Reinhardt MK, et al.
Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: part 2 : Evaluation of System Accuracy. Neurosurgery.
Author: Lieberman IH, Togawa D, Kayanja MM.
Bone-mounted miniature robotic guidance for Pedicle Screw and Translaminar facet screw placement: part I : Technical development and a test case result. Neurosurgery.
Author: Joskovicz L, Shamir R, Freiman M, et al.
Image-guided system with miniature robot for precise positioning and targeting in keyhole neurosurgery. Computer Aided Surgery.
Author: Sukovich W, Brink-Danan S, Hardenbrook M.
Miniature robotic guidance for pedicle screw placement in posterior spinal fusion: early clinical experience with the SpineAssist. Int J Med Robotics Comput Assist Surg.
Author: Barzilay Y, Liebergall M, Fridlander A, Knoller N.
Miniature robotic guidance for spine surgery : Introduction of a novel system and analysis of challenges encountered during the clinical development phase at two spine centres. Int J Med Robotics Comput Assist Surg.
Author: Shoham, M, Burman, M, Zehavi, E, Joskowicz, L, Batkilin, E, Kunicher Y.
Bone mounted miniature robot for surgical procedures: concept and clinical applications. IEEE Transactions on Robotics and Automation.