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Open Access 01-12-2022 | Study protocol

The application of augmented reality in craniofacial bone fracture reduction: study protocol for a randomized controlled trial

Authors: Li Lin, Xiangqi Liu, Yuan Gao, Zin Mar Aung, Haisong Xu, Bingshun Wang, Le Xie, Xianxian Yang, Gang Chai

Published in: Trials | Issue 1/2022

Abstract

Background

Augmented reality (AR) is a new technology that increases users’ perception of the real world. The purpose of this study is to evaluate the efficacy and safety of augmented reality navigation system in treatment with craniofacial fracture reduction.

Methods

This will be a single-center prospective randomized controlled trial. Twenty-two patients will be assigned to two groups of 11, and those with zygomaticomaxillary complex fractures will undergo preoperative three-dimensional CT modeling and have operational plans designed. The control team will use traditional optical navigation to perform the surgery, and the experimental team will use an AR navigation system. The primary outcome measures will be the accuracy of the key points of surgical area between the preoperational surgical plan and post-operation. The secondary outcome measures will be the blood loss, operation time, bone reduction time, hospital time, and complication rate. The findings obtained through this study are expected to evaluate efficacy and safety of the augmented reality navigation system in the treatment of zygomaticomaxillary complex fractures.

Discussion

This controlled trial of augmented reality navigation system in treatment with zygomaticomaxillary complex fracture reduction will clarify the efficacy and safety of this technology by measuring the accuracy of the key points of surgical area and blood loss, operation and bone reduction times, hospital stay duration, and complication rates. This is a single-center study, and the results are expected to promote the application of augmented reality in craniofacial fracture reduction to improve surgery accuracy and efficacy.

Trial registration

Chinese Clinical Trial Registry ChiCTR1900022626. Registered on April 19, 2019.

Raoul G, Dujoncquoy JP, Nicola J, Tison C, Wojcik T, Ferri J. Is transfacial Kirschner wire fixation still indicated in isolated zygomaticomaxillary complex fractures? Retrospective study of 216 cases in CHRU of Lille: epidemiology, therapeutic management, and results. J Craniofac Surg. 2009;20(4):1231–9. https://doi.org/10.1097/SCS.0b013e3181acde63.CrossRefPubMed

Lee EI, Mohan K, Koshy JC, Hollier L. Optimizing the surgical management of zygomaticomaxillary complex fractures. Semin Plast Surg. 2010;24(4):389–97. https://doi.org/10.1055/s-0030-1269768.CrossRefPubMedPubMedCentral

Marinho RO, Freire-Maia B. Management of fractures of the zygomaticomaxillary complex. Oral Maxillofac Surg Clin North Am. 2013;25(4):617–36. https://doi.org/10.1016/j.coms.2013.07.011.CrossRefPubMed

Farber SJ, Nguyen DC, Skolnick GB, Woo AS, Patel KB. Current management of zygomaticomaxillary complex fractures: a multidisciplinary survey and literature review. Craniomaxillofac Trauma Reconstr. 2016;9(4):313–22. https://doi.org/10.1055/s-0036-1592093.CrossRefPubMedPubMedCentral

Susarla SM, Mundinger GS, O'Brien-Coon D, Dodson TB, Manson PN, Peacock ZS, et al. Does training background influence decision-making in the management of zygomaticomaxillary complex fractures? J Oral Maxillofac Surg. 2016;74(5):995–1012. https://doi.org/10.1016/j.joms.2015.11.020.CrossRefPubMed

Birgfeld CB, Mundinger GS, Gruss JS. Evidence-based medicine: evaluation and treatment of zygoma fractures. Plast Reconstr Surg. 2017;139(1):168e–80e. https://doi.org/10.1097/PRS.0000000000002852.CrossRefPubMed

Peretti N, MacLeod S. Zygomaticomaxillary complex fractures: diagnosis and treatment. Curr Opin Otolaryngol Head Neck Surg. 2017;25(4):314–9. https://doi.org/10.1097/MOO.0000000000000372.CrossRefPubMed

Strong EB, Gary C. Management of zygomaticomaxillary complex fractures. Facial Plast Surg Clin North Am. 2017;25(4):547–62. https://doi.org/10.1016/j.fsc.2017.06.006.CrossRefPubMed

Schneider M, Besmens IS, Luo Y, Giovanoli P, Lindenblatt N. Surgical management of isolated orbital floor and zygomaticomaxillary complex fractures with focus on surgical approaches and complications. J Plast Surg Hand Surg. 2020;54(4):200–6. https://doi.org/10.1080/2000656X.2020.1746664.CrossRefPubMed

10.

Cuddy K, Dierks EJ, Cheng A, Patel A, Amundson M, Bell RB. Management of zygomaticomaxillary complex fractures utilizing intraoperative 3-dimensional imaging: The ZYGOMAS Protocol. J Oral Maxillofac Surg. 2021;79(1):177–82. https://doi.org/10.1016/j.joms.2020.08.028.CrossRefPubMed

11.

Zhang X, Ye L, Li H, Wang Y, Dilxat D, Liu W, et al. Surgical navigation improves reductions accuracy of unilateral complicated zygomaticomaxillary complex fractures: a randomized controlled trial. Sci Rep. 2018;8(1):6890. https://doi.org/10.1038/s41598-018-25053-z.CrossRefPubMedPubMedCentral

12.

Lassausaie A, Sesque A, Barthelemy I, et al. Virtual surgery planning and three-dimensional printing template for osteotomy of the zygoma to correct untreated zygomaticomaxillary complex fracture. J Craniofac Surg. 2020;31(4):1142–5. https://doi.org/10.1097/SCS.0000000000006551.CrossRefPubMed

13.

Tel A, Sembronio S, Costa F, Robiony M. Scoping zygomaticomaxillary complex fractures with the eyes of virtual reality: operative protocol and proposal of a modernized classification. J Craniofac Surg. 2021;32(2):552–8. https://doi.org/10.1097/SCS.0000000000006941.CrossRefPubMed

14.

Azuma RT. A survey of augmented reality. Presence-Teleop Virt. 1997;6(4):355–85. https://doi.org/10.1162/pres.1997.6.4.355.CrossRef

15.

Kim Y, Kim H, Kim YO. Virtual reality and augmented reality in plastic surgery: a review. Arch Plast Surg. 2017;44(3):179–87. https://doi.org/10.5999/aps.2017.44.3.179.CrossRefPubMedPubMedCentral

16.

Vavra P, Roman J, Zonca P, et al. Recent development of augmented reality in surgery: A review. J Healthc Eng. 2017;4574172. https://doi.org/10.1155/2017/4574172.

17.

Sayadi LR, Naides A, Eng M, Fijany A, Chopan M, Sayadi JJ, et al. The new frontier: a review of augmented reality and virtual reality in plastic surgery. Aesthet Surg J. 2019;39(9):1007–16. https://doi.org/10.1093/asj/sjz043.CrossRefPubMed

18.

Benmahdjoub M, van Walsum T, van Twisk P, Wolvius EB. Augmented reality in craniomaxillofacial surgery: added value and proposed recommendations through a systematic review of the literature. Int J Oral Maxillofac Surg. 2020;50(7):969–78. https://doi.org/10.1016/j.ijom.2020.11.015.CrossRefPubMed

19.

Negrillo-Cárdenas J, Jiménez-Pérez JR, Feito FR. The role of virtual and augmented reality in orthopedic trauma surgery: from diagnosis to rehabilitation. Comput Methods Programs Biomed. 2020;191:105407. https://doi.org/10.1016/j.cmpb.2020.105407.CrossRefPubMed

20.

Qu M, Hou Y, Xu Y, Shen C, Zhu M, Xie L, et al. Precise positioning of an intraoral distractor using augmented reality in patients with hemifacial microsomia. J Craniomaxillofac Surg. 2015;43(1):106–12. https://doi.org/10.1016/j.jcms.2014.10.019.CrossRefPubMed

21.

Zhu M, Chai G, Lin L, Xin Y, Tan A, Bogari M, et al. Effectiveness of a novel augmented reality-based navigation system in treatment of orbital hypertelorism. Ann Plast Surg. 2016;77(6):662–8. https://doi.org/10.1097/SAP.0000000000000644.CrossRefPubMed

22.

Han W, Yang X, Wu S, Fan S, Chen X, Aung ZM, et al. A new method for cranial vault reconstruction: augmented reality in synostotic plagiocephaly surgery. J Craniomaxillofac Surg. 2019;47(8):1280–4. https://doi.org/10.1016/j.jcms.2019.04.008.CrossRefPubMed

23.

Zhu M, Liu F, Chai G, Pan JJ, Jiang T, Lin L, et al. A novel augmented reality system for displaying inferior alveolar nerve bundles in maxillofacial surgery. Sci Rep. 2017;7(1):42365. https://doi.org/10.1038/srep42365.CrossRefPubMedPubMedCentral

24.

Chen G, Zeng W, Yin H, Yu Y, Ju R, Tang W. The preliminary application of augmented reality in unilateral orbitozygomatic maxillary complex fractures treatment. J Craniofac Surg. 2020;31(2):542–8. https://doi.org/10.1097/SCS.0000000000006238.CrossRefPubMed

25.

Gao Y, Lin L, Chai G, Xie L. A feasibility study of a new method to enhance the augmented reality navigation effect in mandibular angle split osteotomy. J Craniomaxillofac Surg. 2019;47(8):1242–8. https://doi.org/10.1016/j.jcms.2019.04.005.CrossRefPubMed

Title: The application of augmented reality in craniofacial bone fracture reduction: study protocol for a randomized controlled trial
Authors: Li Lin
Xiangqi Liu
Yuan Gao
Zin Mar Aung
Haisong Xu
Bingshun Wang
Le Xie
Xianxian Yang
Gang Chai
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06174-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The application of augmented reality in craniofacial bone fracture reduction: study protocol for a randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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