New Productive Force: The Preliminary Report of First Craniofacial Surgical Robot IST Multicenter Clinical Trial in China
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 39 participants or records.
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