Clinical usability and efficacy of a robotic bone fracture reduction system: A pilot animal study

Abstract

Challenges in minimally invasive surgeries, such as intramedullary nailing for long bone fractures, include radiation overexposure for patients and surgeons, potential malreduction, and physical burden on surgeons in maintaining the reduction status. A robotic bone fracture reduction system was developed in this study to address these problems. The system consists of a hexapod with six degrees of freedom, with a fracture reduction device and a master device. This study aimed to evaluate the novel system in a preclinical setting. The length of the six axes in the system can be adjusted to precisely control the length, angle, and rotation so that no additional traction is required. Fluoroscopic images can be remotely examined to reduce the risk of radiation exposure for surgeons. In this study, alignment accuracy and radiation exposure were measured using 32 bovine bone fracture models, and these surgical outcomes were compared to those of conventional manual surgery to verify the clinical usability and effectiveness of the system. The alignment accuracy was assessed by analyzing length, angulation, and rotation. The four surgeons participating in this study were divided into two groups (expert and novice) according to their clinical experience. All parameters in robotic surgery significantly decreased by approximately 4 mm and 8° on average (p≤0.05) compared to conventional surgery. The mean radiation exposure in robot-assisted surgery was 0.11 mSv, showing a significant decrease compared to conventional surgery (p<0.05). Reduction accuracy was higher in robotic surgery performed by the novice group than in conventional surgery performed by the expert group; however, standard deviation values were inversed. In conclusion, the bone fracture reduction robot system increased the alignment accuracy through precise control while reducing radiation exposure in surgeons, as the surgery was performed remotely. The use of this system is predicted to improve the accuracy and reproducibility of the surgery and the safety of medical staff.11Abbreviations: CT, computed tomography; FRD, fracture reduction device; FRMD, fracture reduction master device; SD, standard deviation