Evidence map›Paper›PMID 38216974›Full record

ArticleTrials2024

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.

Xiangqi Liu, Ziwei Zhang, Wenqing Han, Zhijie Zhao, Byeong Seop Kim, Yingjie Yan, Xiaojun Chen, Xuetong Wang, Xin Li, Xianxian Yang and 4 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

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 HanDepartment 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 ZhaoDepartment 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 KimDepartment 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 YanDepartment 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 ChenDepartment 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 WangDepartment 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 LiDepartment 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 YangDepartment 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 WangDepartment of Biostatistics, Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, 227 Chong Qing Nan Rd., Shanghai, 200025, China.
Haisong XuDepartment 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 LinDepartment 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 ChaiDepartment 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.ORCID http://orcid.org/0000-0002-8311-2520

Funding

Clinical Research Plan of SHDC SHDC2020CR3070BShanghai Jiao Tong University School of Medicine Two-hundred Talent 20161420The project of Shanghai Municipal Key Clinical Specialty shslczdzk00901the project of the Clinical Research Program of 9th People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine JYLJ202108
6 · The paper itself

Abstract

backgroundMandibular 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.

methodsThis 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 registrationChinese Clinical Trial Registry ChiCTR2200061565. Registered on 29 June 2022.

Indexed as

Goldenhar SyndromeOsteogenesis, DistractionAdolescentArtificial IntelligenceChildChild, PreschoolHumansMandibleRandomized Controlled Trials as TopicSingle-Blind MethodElectromagnetic navigationHemifacial macrosomiaMandibular osteotomy

Identifiers

PMID38216974
PMCPMC10785481

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.