New Productive Force: The Preliminary Report of First Craniofacial Surgical Robot IST Multicenter Clinical Trial in China

Background: This paper presents the authors' team's research on a craniofacial surgical robot developed in China. Initiated in 2011 with government funding, the craniofacial surgical robot project was officially launched in Shanghai, developed jointly by the Ninth People's Hospital affiliated with Shanghai Jiao Tong University School of Medicine and the Shanghai Jiao Tong University medical-engineering team. Currently, based on multiple rounds of model surgeries, animal experiments, and clinical trials, our team is applying for approval as a Class III medical device from the National Medical Products Administration (NMPA). As an innovative tool in the field of craniofacial surgery, it fills a technological gap within the country.

Methods: This study is a multicenter cohort study based on patient data from Shanghai Ninth People's Hospital from 2019 to 2024. Inclusion criteria included patients who underwent craniofacial surgery with complete follow-up data, with the primary variable being the use of robotic assistance in craniofacial surgery. Data analysis involved descriptive statistics, t tests, and multivariable regression, with a significance level set at P<0.05.

Results: The craniofacial surgical robot has been widely explored in the fields of congenital deformities, tumor reconstruction, and esthetic surgery. In the clinical trials discussed in this article, which included experiments on both craniofacial deformity correction surgeries and esthetic surgeries, a total of 39 patients were enrolled. In mandibular osteotomy surgery, robotic-assisted procedures can reduce osteotomy length error by an average of 2.2 mm and mandibular angle error by 9.09 degrees, while also decreasing the average surgery time by 10.43 minutes. In hemifacial microsomia distraction osteogenesis surgery, robotic-assisted surgery can reduce osteotomy length error by an average of 4.6 mm and shorten the average surgery time by 60 minutes. The robotic-assisted group also showed better perioperative outcomes for patients. The surgical precision was improved and there was a significant reduction in postoperative complications.

Conclusion: The authors' research team has completed the first multicenter study on craniofacial surgical robots in China, demonstrating that this robot significantly enhances surgical precision, reduces operation time, and improves perioperative patient indicators. These findings indicate that the robot is highly effective in assisting surgeons with complex procedures. The study suggests that, in the future, this robot is likely to be widely adopted in craniofacial surgery, significantly advancing surgical efficiency and precision, and bringing transformative progress to clinical practice.