A preliminary study of a novel robotic system for pedicle screw fixation: A randomised controlled trial

Abstract

Background and objectiveExisting orthopaedic robotic systems are almost restricted to provide guidance for trajectory direction. In the present study, a novel spinal robotic system with automatic drilling power was introduced. The aim of this study is to evaluate the feasibility and safety in pedicle screw ​insertion of posterior lumbar interbody fusion assisted by this novel robotic system.Methods and materialsA randomised controlled trial was conducted for 17 participants who were required posterior lumbar interbody fusion process. Seven (3 M/4 F) were randomly assigned to the robot-assisted group (RA group), and the other ten (4 M/6 F) were assigned to the conventional technique group (FH group). A novel robotic system was used in the RA group. All measurements were based on postoperative computed tomography (CT) data. Accuracy of screw insertion was determined using the Gertzbein and Robbins Scale. Precision was measured by the entry point deviation distance and the trajectory rotation. Other variables included operation time, radiation time, length of stay, and screw-related complications.ResultA total of 82 pedicle screws were placed in the 17 participants. In the RA group, 90.6% of screws placed were Grade A, and 9.4% were Grade B. In the FH group, 78.0% of screws were Grade A, 20.0% were Grade B, and 2.0% were Grade C. No statistical difference was found in the operation time, radiation time per case, and length of stay between both groups. The radiation time per screw is significantly lower in the RA group. No screw-related complications or revision occurred in the present study.ConclusionThe outcome of screw accuracy of this robotic system was comparable with that of experienced surgeons, and no screw-related complication was found in the RA group during hospitalisation. In addition, radiation time per screw in the robotic group was significantly lower than that in the conventional group, which shows the potential to reduce radiation exposure of pedicle screw fixation assisted by this robotic system.Translational potentialOur study shows that pedicle screw fixation assisted by “Orthbot” system is accurate and safe. It is concluded that this novel robotic system offers a new option for internal implantation in spine surgery.

Initial Intraoperative Experience with Robotic-Assisted Pedicle Screw Placement with Cirq® Robotic Alignment: An Evaluation of the First 70 Screws

“…Most spinal surgery robots are shared-control robots that simultaneously provide both the surgeon and robot the ability to control instruments and motions [25]. There are several studies evaluating the utility of pedicle-screw implantation using robotic-guided spine surgery with different systems, such as, Mazor X, Mazor Robotics Ltd., Caesarea, Israel [26], Mazor [27], SpineAssist Mazor [9,12,[28][29][30], Excelsius GPS ® ; Globus Medical, Inc. Audubon, PA, USA [2,31,32], ROSA spine robot technology (Zimmer-Biomet, Warsaw, Indiana, USA) [33], Orthbot [34] and TiRobot [35]. Unfortunately, direct comparisons of screw placement accuracy between these systems are difficult because of the significant cost and time associated with their adoption [36].…”

Association of robot-assisted techniques with the accuracy rates of pedicle screw placement: A network pooling analysis

“…The flow diagram in Figure 1 shows the patient selection process, with inclusion and exclusion criteria. 2046 participants (male: 46.22%; female: 53.78%) were included from 26 trials, 3 , 5 , 11 , 12 , 13 , 14 , 16 , 17 , 18 , 19 , 21 , 22 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 conducted in China ( n = 9), 3 , 11 , 16 , 19 , 36 , 38 , 39 , 40 , 41 Germany ( n = 7), 12 , 17 , 18 , 22 , 30 , 32 , 37 the United States of America ( n = 3), 28 , 31 , 33 Switzerland ( n = 3), 5 , 29 , 35 South Korea ( n = 3) 13 , 21 , 34 and France ( n = 1). 14 The robotic systems used for pedicle screw placement included SpineAssist ( n = 10), 5 , 12 , 18 , 22 , 28 …”

“… 14 The robotic systems used for pedicle screw placement included SpineAssist ( n = 10), 5 , 12 , 18 , 22 , 28 , 29 , 30 , 32 , 35 Renaissance ( n = 7), 3 , 13 , 17 , 21 , 33 , 34 , 37 TiR7obot ( n = 7), 16 , 19 , 36 , 38 , 39 , 40 , 41 ROSA ( n = 1), 14 and Orthbot ( n = 1). 11 Five studies were found to have a low risk for randomization sequence generation 13 , 16 , 21 , 34 , 36 and four did not provide this information. 11 , 22 , 30 , 39 Seven studies showed a low risk in concealing allocation, 11 , 13 , 16 , 21 , 34 , 36 , 39 with two not providing this information.…”

“… 10 With the advent of new robotic navigation technologies, robotic surgery has experienced significant expansion in recent years due to its high precision and stability. 11 SpineAssist is a spine-mounted robot that improves screw positioning accuracy and reduces intraoperative radiation exposure. 12 The Renaissance® is the Mazor's second-generation spine robot, replacing the SpineAssist in 2011.…”

“…15 , 16 Finally, Orthbot is a novel spinal robotic system with automatic drilling power that has been introduced recently. 11 …”