Evaluation of a new spinal surgical robotic system of Kirschner wire placement for lumbar fusion: A multi‐centre, randomised controlled clinical study

Abstract

Background To introduce a novel robotic system ‘Orthbot’ that has been developed and tested as a surgical assistant for auto‐placement of the K‐wire in lumbar fusion. Methods This is a multi‐centre, randomized controlled clinical study that includes 56 patients (robot group, RG: 27, free‐hand group, FG: 29). Following the pre‐operative planning and intra‐operative fluoroscopic images, the ‘Orthbot’ automatically completed registration and K‐wire placement under the supervision of the surgeon. Deviation distance (DD) and deviation angle (DA) were used as the primary parameters to evaluate the accuracy of the robotic system. Results The average DD was 0.95 ± 0.377 mm and 4.35 ± 2.01 mm, respectively in the RG and FG (p < 0.001). The average DA of the K‐wire in the coronal plane and the sagittal plane in X‐Ray was respectively 6.80 ± 7.79° and 1.27 ± 2.32° in the RG (p < 0.001), and 22.22 ± 16.85° and 4.57 ± 3.86° in the FG (p < 0.001), which showed a higher accuracy rate in the robotic‐assisted cases compared to the free‐hand cases. Conclusions The novel robotic system could achieve accurate K‐wire insertions as indicated by the radiological results.

AOSRV: Development and preliminary performance assessment of a new robotic system for autonomous percutaneous vertebroplasty

“…In their study, there was no statistical difference in the acceptability rate of puncture path between the robotic group and the manual group, but the entry point deviation and trajectory rotation angle of the robot group were significantly reduced. In addition, in a multi‐centre randomized controlled clinical study, the results confirmed that Orthbot had remarkable accuracy, complete automation, satisfactory clinical outcomes and excellent ability to follow preoperative plannings 29 . The results also showed that the average deviation distance (DD) of the screw was 0.95 ± 0.377 mm in the RG and 4.35 ± 2.01 mm in the FG ( p < 0.001).…”

“…In addition, in a multi-centre randomized controlled clinical study, the results confirmed that Orthbot had remarkable accuracy, complete automation, satisfactory clinical outcomes and excellent ability to follow preoperative plannings. 29 The results also showed that the average deviation distance (DD) of the screw was 0.95 � 0.377 mm in the RG and 4.35 � 2.01 mm in the FG (p < 0.001). The DD of pedicle screw tips in the RG and FG was respectively 0.91 � 0.47 mm and 4.01 � 2.58 mm.…”

Accuracy and postoperative assessment of robot-assisted placement of pedicle screws during scoliosis surgery compared with conventional freehand technique: a systematic review and meta-analysis

“…Mazor SpineAssist (Mazor Surgical Technologies, Caesarea, Israel), approved by the United States Food and Drug Administration (FDA) in 2004, was the first FDA-approved spinal surgery robot in the United States [8,24]. Since then, several spinal robotic systems have been developed, including Mazor Robotics, Orthbot [25,26], and TiRobot [27,28]. Moreover, in the past decade, new robotic platforms called ExcelsiusGPS® [29] have emerged that integrate semiautomated robotics with real-time 3D navigation technology.…”

Clinical efficacy of robotic spine surgery: an updated systematic review of 20 randomized controlled trials

“…The precise positioning performance of robots has greatly promoted the development of minimally invasive surgery (15,16). Recently, some new spinal robotic systems are introduced into clinical use (17,18).…”