A prospective, randomized, controlled trial of robot-assisted vs freehand pedicle screw fixation in spine surgery.
01 Sep 2017-International Journal of Medical Robotics and Computer Assisted Surgery (Int J Med Robot)-Vol. 13, Iss: 3
TL;DR: The purpose of this study was to compare the accuracy and safety of an instrumented posterior lumbar interbody fusion using a robot‐assisted minimally invasive (Robot‐PLIF) or a conventional open approach (Freehand‐ PLIF).
Abstract: Background
The purpose of this study was to compare the accuracy and safety of an instrumented posterior lumbar interbody fusion (PLIF) using a robot-assisted minimally invasive (Robot-PLIF) or a conventional open approach (Freehand-PLIF).
Methods
Patients undergoing an instrumented PLIF were randomly assigned to be treated using a Robot-PLIF (37 patients) and a Freehand-PLIF (41 patients).
Results
For intrapedicular accuracy, there was no significant difference between the groups (P = 0.534). For proximal facet joint accuracy, none of the 74 screws in the Robot-PLIF group violated the proximal facet joint, while 13 of 82 in the Freehand-PLIF group violated the proximal facet joint (P < 0.001). The average distance of the screws from the facets was 5.2 ± 2.1 mm and 2.7 ± 1.6 mm in the Robot-PLIF and Freehand-PLIF groups, respectively (P < 0.001).
Conclusion
Robotic-assisted pedicle screw placement was associated with fewer proximal facet joint violations and better convergence orientations.
Citations
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TL;DR: A retrospective case review found that robot-guided pedicle screw placement is a safe, useful, and potentially more accurate alternative to the conventional freehand technique for the placement of thoracolumbar spinal instrumentation.
Abstract: OBJECTIVE The quest to improve the safety and accuracy and decrease the invasiveness of pedicle screw placement in spine surgery has led to a markedly increased interest in robotic technology. The SpineAssist from Mazor is one of the most widely distributed robotic systems. The aim of this study was to compare the accuracy of robot-guided and conventional freehand fluoroscopy-guided pedicle screw placement in thoracolumbar surgery. METHODS This study is a retrospective series of 169 patients (83 women [49%]) who underwent placement of pedicle screw instrumentation from 2007 to 2015 in 2 reference centers. Pathological entities included degenerative disorders, tumors, and traumatic cases. In the robot-assisted cohort (98 patients, 439 screws), pedicle screws were inserted with robotic assistance. In the freehand fluoroscopy-guided cohort (71 patients, 441 screws), screws were inserted using anatomical landmarks and lateral fluoroscopic guidance. Patients treated before 2009 were included in the fluoroscopy cohort, whereas those treated since mid-2009 (when the robot was acquired) were included in the robot cohort. Since then, the decision to operate using robotic assistance or conventional freehand technique has been based on surgeon preference and logistics. The accuracy of screw placement was assessed based on the Gertzbein-Robbins scale by a neuroradiologist blinded to treatment group. The radiological slice with the largest visible deviation from the pedicle was chosen for grading. A pedicle breach of 2 mm or less was deemed acceptable (Grades A and B) while deviations greater than 2 mm (Grades C, D, and E) were classified as misplacements. RESULTS In the robot-assisted cohort, a perfect trajectory (Grade A) was observed for 366 screws (83.4%). The remaining screws were Grades B (n = 44 [10%]), C (n = 15 [3.4%]), D (n = 8 [1.8%]), and E (n = 6 [1.4%]). In the fluoroscopy-guided group, a completely intrapedicular course graded as A was found in 76% (n = 335). The remaining screws were Grades B (n = 57 [12.9%]), C (n = 29 [6.6%]), D (n = 12 [2.7%]), and E (n = 8 [1.8%]). The proportion of non-misplaced screws (corresponding to Gertzbein-Robbins Grades A and B) was higher in the robot-assisted group (93.4%) than the freehand fluoroscopy group (88.9%) (p = 0.005). CONCLUSIONS The authors' retrospective case review found that robot-guided pedicle screw placement is a safe, useful, and potentially more accurate alternative to the conventional freehand technique for the placement of thoracolumbar spinal instrumentation.
144 citations
TL;DR: Evidence supporting that total operative time is prolonged in robot-assisted surgery compared to conventional free-hand and the effective consequence of robot-assistance on radiation exposure, length of stay, and operative time remains unclear and requires meticulous examination in future studies.
Abstract: Study Design.Systematic review.Objective.The authors aim to review comparative outcome measures between robotic and free-hand spine surgical procedures including: accuracy of spinal instrumentation, radiation exposure, operative time, hospital stay, and complication rates.Summary of Background Data.
139 citations
07 Nov 2019
TL;DR: This review discusses the history of spinal robots along as well as currently available systems, and examines accuracy, operative time, complications, radiation exposure, and costs – comparing robotic-assisted to traditional fluoroscopy-assisted freehand approaches.
Abstract: Robot-assisted spine surgery has recently emerged as a viable tool to enable less invasive and higher precision surgery. The first-ever spine robot, the SpineAssist (Mazor Robotics Ltd., Caesarea, Israel), gained FDA approval in 2004. With its ability to provide real-time intraoperative navigation and rigid stereotaxy, robotic-assisted surgery has the potential to increase accuracy while decreasing radiation exposure, complication rates, operative time, and recovery time. Currently, robotic assistance is mainly restricted to spinal fusion and instrumentation procedures, but recent studies have demonstrated its use in increasingly complex procedures such as spinal tumor resections and ablations, vertebroplasties, and deformity correction. However, robots do require high initial costs and training, and thus, require justification for their incorporation into common practice. In this review, we discuss the history of spinal robots along as well as currently available systems. We then examine the literature to evaluate accuracy, operative time, complications, radiation exposure, and costs - comparing robotic-assisted to traditional fluoroscopy-assisted freehand approaches. Finally, we consider future applications for robots in spine surgery.
137 citations
Cites background from "A prospective, randomized, controll..."
...For this reason, they suggested that at least 10 cases are necessary to gain the experience needed to minimize radiation exposure time.(78) Kaul et al concluded that da Vinci assistance decreased the learning curve for standardized tasks as well as actual laparoscopic operations....
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...Specifically, Kim et al found that total fluoroscopy time decreased by 30% after the first eight cases.(78) For this reason, they suggested that at least 10 cases are necessary to gain the experience needed to minimize radiation exposure time....
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TL;DR: Surgical accuracy in instrumentation implanted using robotics appears to be high, however, the impact of robotics on radiation exposure is not clear and seems to be dependent on technique and robot type.
Abstract: OBJECTIVE Surgical robotics has demonstrated utility across the spectrum of surgery. Robotics in spine surgery, however, remains in its infancy. Here, the authors systematically review the evidence behind robotic applications in spinal instrumentation. METHODS This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Relevant studies (through October 2016) that reported the use of robotics in spinal instrumentation were identified from a search of the PubMed database. Data regarding the accuracy of screw placement, surgeon learning curve, radiation exposure, and reasons for robotic failure were extracted. RESULTS Twenty-five studies describing 2 unique robots met inclusion criteria. Of these, 22 studies evaluated accuracy of spinal instrumentation. Although grading of pedicle screw accuracy was variable, the most commonly used method was the Gertzbein and Robbins system of classification. In the studies using the Gertzbein and Robbins system, accuracy (Grades A and B) ranged from 85% to 100%. Ten studies evaluated radiation exposure during the procedure. In studies that detailed fluoroscopy usage, overall fluoroscopy times ranged from 1.3 to 34 seconds per screw. Nine studies examined the learning curve for the surgeon, and 12 studies described causes of robotic failure, which included registration failure, soft-tissue hindrance, and lateral skiving of the drill guide. CONCLUSIONS Robotics in spine surgery is an emerging technology that holds promise for future applications. Surgical accuracy in instrumentation implanted using robotics appears to be high. However, the impact of robotics on radiation exposure is not clear and seems to be dependent on technique and robot type.
131 citations
TL;DR: Pedicle screw placement for metastatic disease in the thoracolumbar spine can be performed effectively and safely using robot-guided assistance, and accuracy, radiation time, and postoperative infection rates are comparable to those of the conventional technique.
Abstract: OBJECTIVE Robot-guided pedicle screw placement is an established technique for the placement of pedicle screws. However, most studies have focused on degenerative disease. In this paper, the authors focus on metastatic spinal disease, which is associated with osteolysis. The associated lack of dense bone may potentially affect the automatic recognition accuracy of radiography-based surgical assistance systems. The aim of the present study is to compare the accuracy of the SpineAssist robot system with conventional fluoroscopy-guided pedicle screw placement for thoracolumbar metastatic spinal disease. METHODS Seventy patients with metastatic spinal disease who required instrumentation were included in this retrospective matched-cohort study. All 70 patients underwent surgery performed by the same team of experienced surgeons. The decision to use robot-assisted or fluoroscopy-guided pedicle screw placement was based the availability of the robot system. In patients who underwent surgery with robot guidance, pedicle screws were inserted after preoperative planning and intraoperative fluoroscopic matching. In the "conventional" group, anatomical landmarks and anteroposterior and lateral fluoroscopy guided placement of the pedicle screws. The primary outcome measure was the accuracy of screw placement on the Gertzbein-Robbins scale. Grades A and B (< 2-mm pedicle breach) were considered clinically acceptable, and all other grades indicated misplacement. Secondary outcome measures included an intergroup comparison of direction of screw misplacement, surgical site infection, and radiation exposure. RESULTS A total of 406 screws were placed at 206 levels. Sixty-one (29.6%) surgically treated levels were in the upper thoracic spine (T1-6), 74 (35.9%) were in the lower thoracic spine, and the remaining 71 (34.4%) were in the lumbosacral region. In the robot-assisted group (Group I; n = 35, 192 screws), trajectories were Grade A or B in 162 (84.4%) of screws. The misplacement rate was 15.6% (30 of 192 screws). In the conventional group (Group II; n = 35, 214 screws), 83.6% (179 of 214) of screw trajectories were acceptable, with a misplacement rate of 16.4% (35 of 214). There was no difference in screw accuracy between the groups (chi-square, 2-tailed Fisher's exact, p = 0.89). One screw misplacement in the fluoroscopy group required a second surgery (0.5%), but no revisions were required in the robot group. There was no difference in surgical site infections between the 2 groups (Group I, 5 patients [14.3%]; Group II, 8 patients [22.9%]) or in the duration of surgery between the 2 groups (Group I, 226.1 ± 78.8 minutes; Group II, 264.1 ± 124.3 minutes; p = 0.13). There was also no difference in radiation time between the groups (Group I, 138.2 ± 73.0 seconds; Group II, 126.5 ± 95.6 seconds; p = 0.61), but the radiation intensity was higher in the robot group (Group I, 2.8 ± 0.2 mAs; Group II, 2.0 ± 0.6 mAs; p < 0.01). CONCLUSIONS Pedicle screw placement for metastatic disease in the thoracolumbar spine can be performed effectively and safely using robot-guided assistance. Based on this retrospective analysis, accuracy, radiation time, and postoperative infection rates are comparable to those of the conventional technique.
115 citations
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"A prospective, randomized, controll..." refers result in this paper
...There have been conflicting results regarding the safety and accuracy of robot‐assisted pedicle screw fixation.(2,4,6,7) Therefore, the present randomized controlled trial was intended to assess these issues in posterior lumbar fusion surgery, compared with the conventional open free‐hand technique....
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...2 at the setting of a single measurement and absolute agreement.(13) A minimum of fifty‐one pedicle screws was calculated as the required sample size....
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