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
Abstract Background 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...
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| Format: | Article |
| Language: | English |
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BMC
2024-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07809-9 |
| _version_ | 1797355536606298112 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Xiangqi Liu |
| collection | DOAJ |
| description | Abstract Background 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. Methods 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. Discussion 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. Trial registration Chinese Clinical Trial Registry ChiCTR2200061565. Registered on 29 June 2022. |
| first_indexed | 2024-03-08T14:13:34Z |
| format | Article |
| id | doaj.art-d20b119c435747ddb0d76cc7c08b8648 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-08T14:13:34Z |
| publishDate | 2024-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d20b119c435747ddb0d76cc7c08b86482024-01-14T12:35:24ZengBMCTrials1745-62152024-01-0125111110.1186/s13063-023-07809-9Efficacy 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 trialXiangqi Liu0Ziwei Zhang1Wenqing Han2Zhijie Zhao3Byeong Seop Kim4Yingjie Yan5Xiaojun Chen6Xuetong Wang7Xin Li8Xianxian Yang9Bingshun Wang10Haisong Xu11Li Lin12Gang Chai13Department of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Biostatistics, Clinical Research Institute, Shanghai Jiao Tong University School of MedicineDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityDepartment of Plastic and Reconstructive Surgery, Shanghai 9Th People’s Hospital, School of Medicine, Shanghai Jiao Tong UniversityAbstract Background 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. Methods 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. Discussion 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. Trial registration Chinese Clinical Trial Registry ChiCTR2200061565. Registered on 29 June 2022.https://doi.org/10.1186/s13063-023-07809-9Electromagnetic navigationHemifacial macrosomiaMandibular osteotomy |
| spellingShingle | 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 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 Trials Electromagnetic navigation Hemifacial macrosomia Mandibular osteotomy |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Electromagnetic navigation Hemifacial macrosomia Mandibular osteotomy |
| url | https://doi.org/10.1186/s13063-023-07809-9 |
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