Efficacy of navigation system-assisted distraction osteogenesis for hemifacial microsomia based on artificial intelligence for 3 to 18 years old: study protocol for a randomized controlled single-blind trial.

Jan 15, 2024

Contributors: Xiangqi Liu,Ziwei Zhang,Wenqing Han,Zhijie Zhao,Byeong Seop Kim,Yingjie Yan,Xiaojun Chen,Xuetong Wang,Xin Li,Xianxian Yang,Bingshun Wang,Haisong Xu,Li Lin,Gang Chai

Mandibular distraction osteogenesis (MDO) is a major part of the treatment for hemifacial microsomia patients. Due to the narrow surgical field of the intraoral approach, osteotomy accuracy is highly dependent on the surgeons’ experience. Electromagnetic (EM) tracking systems can achieve satisfying accuracy to provide helpful real-time surgical navigation. Our research team developed an EM navigation system based on artificial intelligence, which has been justified in improving the accuracy of osteotomy in the MDO in animal experiments. This study aims to clarify the effect of the EM navigation system in improving the MDO accuracy for hemifacial microsomia patients.
This study is designed as a single-centered and randomized controlled trial. Altogether, 22 hemifacial microsomia patients are randomly assigned to the experiment and control groups. All patients receive three-dimensional CT scans and preoperative surgical plans. The EM navigation system will be set up for those in the experiment group, and the control group will undergo traditional surgery. The primary outcome is the surgical precision by comparing the osteotomy position of pre- and postoperative CT scan images through the Geomagic Control software. The secondary outcomes include mandibular symmetry (occlusal plane deviation angle, mandibular ramus height, and body length), pain scale, and complications. Other indications, such as the adverse events of the system and the satisfactory score from patients and their families, will be recorded.
This small sample randomized controlled trial intends to explore the application of an EM navigation system in MDO for patients, which has been adopted in other surgeries such as orthognathic procedures. Because of the delicate structures of children and the narrow surgical view, accurate osteotomy and protection of nearby tissue from injury are essential for successful treatment. The EM navigation system based on artificial intelligence adopted in this trial is hypothesized to provide precise real-time navigation for surgeons and optimally improve patient outcomes, including function and aesthetic results. The results of this trial will extend the application of new navigation technology in pediatric plastic surgery.
Chinese Clinical Trial Registry ChiCTR2200061565. Registered on 29 June 2022.

© 2024. The Author(s).

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ABOUT THE CONTRIBUTORS

Xiangqi Liu,Ziwei Zhang,Wenqing Han,Zhijie Zhao,Byeong Seop Kim,Yingjie Yan,Xiaojun Chen,Xuetong Wang,Xin Li,Xianxian Yang,Bingshun Wang,Haisong Xu,Li Lin,Gang Chai
Xiangqi Liu

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Ziwei Zhang

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Wenqing Han

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Zhijie Zhao

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Byeong Seop Kim

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Yingjie Yan

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Xiaojun Chen

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Xuetong Wang

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Xin Li

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Xianxian Yang

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Bingshun Wang

Department of Biostatistics, Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, 227 Chong Qing Nan Rd., Shanghai, 200025, China.

Haisong Xu

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China.

Li Lin

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China. linli991@sjtu.edu.cn.

Gang Chai

Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong University, 639 Zhi Zao Ju Rd., Shanghai, 200011, China. chaig1081@sh9hospital.org.cn.