The Prospective, Single-Center, Randomized Controlled Trial: Assessment of Craniofacial Robot-Assisted Surgery in Comparison With Traditional Surgery

Abstract

Background: The clinical research reports on robot-assisted surgery (RAS) in mandibular contouring surgery are lacking. Our objective was to follow up on the effectiveness and safety of RAS for craniofacial bone surgery over a long period of time. Methods: This small sample early phase prospective randomized controlled study included patients diagnosed with mandibular deformity requiring mandibular contouring surgery. Patients of both genders aged 18-30 years who did not have complicated craniofacial repair defects were enrolled and were randomly assigned in a 1:1 ratio by a permuted-block randomized assignments list that was generated by the study statistician. The control group was treated with traditional mandibular contouring surgery, while the experimental group was treated with robot-assisted mandibular contouring surgery. This was an open trial, but patients and evaluators did not know the grouping of patients. The primary outcomes were the position accuracy and angle accuracy of the osteotomy plane. We conducted third-party measurement and evaluation on the accuracy of outcomes 1 week after surgery. Surgical auxiliary measurement index, patient satisfaction scale, surgical pain scale, perioperative period, and complications at 1 week, 1 month, and 6 months after surgery were also analyzed. Findings: From July 11, 2017 to August 20, 2019, 30 patients, 15 in the RAS group and 15 in the traditional surgery group, were enrolled in the study. One patient was lost to follow-up in the final experiment (controlled group), resulting in a total of 14 patients in the traditional surgery group and 15 in the robot-assisted group, whose data were used for statistical analysis. Among the primary outcomes, there was a significant difference in the position accuracy and angle accuracy between the preoperative design and the actual postoperative osteotomy CT between the traditional surgery group and the robot-assisted group. Among the secondary outcomes, apart from the deviation distance of inferior alveolar nerve to the mandibular cutting plane and bone cutting volume compared with the surgical simulation, there was no significant difference in terms of other surgical auxiliary measurement index, patient satisfaction scale, surgical pain scale, perioperative period, and complications. Interpretation: Compared to traditional surgery, robot-assisted mandibular contouring surgery showed obviously improved precision in bone cutting. What’s more, this technology did not increase the risk of patients. However, this technology needs further clinic trial for effectiveness and safety with more cases according to the findings of this early-phase trial. Trial Registration: The Trial was registered in the Chinese Clinical Trial Registry with the registration number chicTR-Inr17011795. Funding Statement: This work was supported by National Natural Science Foundation of China (No. 61672341，61973211，51911540479); The project of Science and Technology Commission of Shanghai Municipality (No. 17441903800, 18DZ2201900, 19441912300); The project of Science and Technology Commission of Fujian Province (No. 2018H0032); The project Science and Technology Department of Hainan Province (ZDYF2018022); The project of Science and Technology Commission of Quanzhou municipality (No. 2018Z028); The project of SJTU Medical and Engineering Cross Fund (No. YG2017ZD03); the project of Interdisciplinary Program of Shanghai Jiao Tong University (ZH2018QNB31)；and the project of Shanghai Jiao Tong University School of Medicine Two-hundred Talent (No. 20161420). Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: This study was approved by the Independent Ethics Committee of Shanghai Ninth People’ s Hospital affiliated with the Shanghai Jiao Tong University, School of Medicine. The clinical study was conducted according to the requirements of the ethics committee.