- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03075384
Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System
Application of Computer-Assisted Navigation System in the Treatment of Unilateral Complicated Zygomatic Complex Fractures: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this prospective randomized controlled trial, twenty patients with unilateral complicated zygomatic fractures were divided into experimental and control groups. Patients in the experimental group were treated with open reduction and internal fixation with the assistance of surgical navigation technology, and patients in the control group without it. Preoperative and postoperative CT data were obtained to measure surgical landmarks discrepancy between the 2 groups. The Chi-square Test and t-test were conducted to test whether there was significant difference in the accuracy between the two groups. Evaluating the effect of fixation by the data and clinical symptoms.
Twenty patients with unilateral complicated zygomatic-complex fractures received operation. All patients healed and their function and facial contour were improved obviously. Postoperative clinical symptoms were not significantly different between the two groups (P>0.05). Compared with the control group, discrepancy of surgical landmarks measured by software Geomagic studio 11, Brainlabiplan CMF 3.0 were significantly low in the experimental group (P<0.05). Software measurement showed the symmetry of zygomatic area and the effect of the fixation in the experimental group were more satisfactory than the control group.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Unilateral ZMC fractures including complete monofragment zygomatic or tetrapod fracture, multifragment or comminuted fracture
- Patients were sane and the age were between 18 to 60 years
- Patients suffered facial deformity and dysfunction which need be treated by operation
- There is no contraindication in patients
- The study were conducted after patient's informed consent
Exclusion Criteria:
- Cases in which technical problems or registration fails occur and patients who were lost to follow-up within 1 year are excluded from this study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
open reduction and internal fixation
A classic method was used to treat unilateral complicated zygomatic fractures without the assistance of computer-assisted navigation system
|
The computer-assisted navigation system was applied in treatment of unilateral complicated zygomatic fractures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
accuracy of the reduction of the fractures
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lei Liu, DMD, Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
Publications and helpful links
General Publications
- Fitzpatrick JM. The role of registration in accurate surgical guidance. Proc Inst Mech Eng H. 2010;224(5):607-22. doi: 10.1243/09544119JEIM589.
- Bogusiak K, Arkuszewski P. Characteristics and epidemiology of zygomaticomaxillary complex fractures. J Craniofac Surg. 2010 Jul;21(4):1018-23. doi: 10.1097/scs.0b013e3181e62e47.
- Naveen Shankar A, Naveen Shankar V, Hegde N, Sharma, Prasad R. The pattern of the maxillofacial fractures - A multicentre retrospective study. J Craniomaxillofac Surg. 2012 Dec;40(8):675-9. doi: 10.1016/j.jcms.2011.11.004. Epub 2011 Dec 31.
- Rana M, Warraich R, Tahir S, Iqbal A, von See C, Eckardt AM, Gellrich NC. Surgical treatment of zygomatic bone fracture using two points fixation versus three point fixation--a randomised prospective clinical trial. Trials. 2012 Apr 12;13:36. doi: 10.1186/1745-6215-13-36.
- Kuhnel TS, Reichert TE. Trauma of the midface. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2015 Dec 22;14:Doc06. doi: 10.3205/cto000121. eCollection 2015.
- Yu H, Shen G, Wang X, Zhang S. Navigation-guided reduction and orbital floor reconstruction in the treatment of zygomatic-orbital-maxillary complex fractures. J Oral Maxillofac Surg. 2010 Jan;68(1):28-34. doi: 10.1016/j.joms.2009.07.058.
- Katzen JT, Jarrahy R, Eby JB, Mathiasen RA, Margulies DR, Shahinian HK. Craniofacial and skull base trauma. J Trauma. 2003 May;54(5):1026-34. doi: 10.1097/01.TA.0000066180.14666.8B.
- Jamal BT, Pfahler SM, Lane KA, Bilyk JR, Pribitkin EA, Diecidue RJ, Taub DI. Ophthalmic injuries in patients with zygomaticomaxillary complex fractures requiring surgical repair. J Oral Maxillofac Surg. 2009 May;67(5):986-9. doi: 10.1016/j.joms.2008.12.035.
- Wang TH, Ma H, Tseng CS, Chou YH, Cai KL. Using Free Navigation Reference Points and Prefabricated Bone Plates for Zygoma Fracture Model Surgeries. J Med Biol Eng. 2016;36:316-324. doi: 10.1007/s40846-016-0144-x. Epub 2016 Jun 6.
- Lubbers HT, Jacobsen C, Matthews F, Gratz KW, Kruse A, Obwegeser JA. Surgical navigation in craniomaxillofacial surgery: expensive toy or useful tool? A classification of different indications. J Oral Maxillofac Surg. 2011 Jan;69(1):300-8. doi: 10.1016/j.joms.2010.07.016. Epub 2010 Nov 2. No abstract available.
- Westendorff C, Gulicher D, Dammann F, Reinert S, Hoffmann J. Computer-assisted surgical treatment of orbitozygomatic fractures. J Craniofac Surg. 2006 Sep;17(5):837-42. doi: 10.1097/01.scs.0000221523.80292.93.
- Pham AM, Rafii AA, Metzger MC, Jamali A, Strong EB. Computer modeling and intraoperative navigation in maxillofacial surgery. Otolaryngol Head Neck Surg. 2007 Oct;137(4):624-31. doi: 10.1016/j.otohns.2007.06.719.
- Morrison CS, Taylor HO, Sullivan SR. Utilization of intraoperative 3D navigation for delayed reconstruction of orbitozygomatic complex fractures. J Craniofac Surg. 2013 May;24(3):e284-6. doi: 10.1097/SCS.0b013e31828f2a71.
- Scolozzi P, Terzic A. "Mirroring" computational planning, navigation guidance system, and intraoperative mobile C-arm cone-beam computed tomography with flat-panel detector: a new rationale in primary and secondary treatment of midfacial fractures? J Oral Maxillofac Surg. 2011 Jun;69(6):1697-707. doi: 10.1016/j.joms.2010.07.049. Epub 2010 Dec 24. No abstract available.
- Ellis E 3rd, Kittidumkerng W. Analysis of treatment for isolated zygomaticomaxillary complex fractures. J Oral Maxillofac Surg. 1996 Apr;54(4):386-400; discussion 400-1. doi: 10.1016/s0278-2391(96)90107-x.
- van Hout WM, Van Cann EM, Koole R, Rosenberg AJ. Surgical treatment of unilateral zygomaticomaxillary complex fractures: A 7-year observational study assessing treatment outcome in 153 cases. J Craniomaxillofac Surg. 2016 Nov;44(11):1859-1865. doi: 10.1016/j.jcms.2016.09.002. Epub 2016 Sep 13.
- Zingg M, Laedrach K, Chen J, Chowdhury K, Vuillemin T, Sutter F, Raveh J. Classification and treatment of zygomatic fractures: a review of 1,025 cases. J Oral Maxillofac Surg. 1992 Aug;50(8):778-90. doi: 10.1016/0278-2391(92)90266-3.
- Heiland M, Habermann CR, Schmelzle R. Indications and limitations of intraoperative navigation in maxillofacial surgery. J Oral Maxillofac Surg. 2004 Sep;62(9):1059-63. doi: 10.1016/j.joms.2004.02.013.
- Yu H, Shen SG, Wang X, Zhang L, Zhang S. The indication and application of computer-assisted navigation in oral and maxillofacial surgery-Shanghai's experience based on 104 cases. J Craniomaxillofac Surg. 2013 Dec;41(8):770-4. doi: 10.1016/j.jcms.2013.01.016. Epub 2013 Feb 23.
- Luebbers HT, Messmer P, Obwegeser JA, Zwahlen RA, Kikinis R, Graetz KW, Matthews F. Comparison of different registration methods for surgical navigation in cranio-maxillofacial surgery. J Craniomaxillofac Surg. 2008 Mar;36(2):109-16. doi: 10.1016/j.jcms.2007.09.002. Epub 2008 Feb 14.
- Kang SH, Kim MK, Kim JH, Park HK, Park W. Marker-free registration for the accurate integration of CT images and the subject's anatomy during navigation surgery of the maxillary sinus. Dentomaxillofac Radiol. 2012 Dec;41(8):679-85. doi: 10.1259/dmfr/21358271. Epub 2012 Apr 12.
- He Y, Zhang Y, An JG, Gong X, Feng ZQ, Guo CB. Zygomatic surface marker-assisted surgical navigation: a new computer-assisted navigation method for accurate treatment of delayed zygomatic fractures. J Oral Maxillofac Surg. 2013 Dec;71(12):2101-14. doi: 10.1016/j.joms.2013.07.003.
- Zhang W, Wang C, Shen G, Wang X, Cai M, Gui H, Liu Y, Yang D. A novel device for preoperative registration and automatic tracking in cranio-maxillofacial image guided surgery. Comput Aided Surg. 2012;17(5):259-67. doi: 10.3109/10929088.2012.710251.
- Jia H, Chen Q, Cao R, Yang J, Huang Q, Wang Z, Wu H. [A comparison between anatomical landmark registration and surface registration for computer-assisted endoscopic sinus surgery]. Lin Chung Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2010 Jan;24(2):49-52, 56. Chinese.
- Hardy SM, Melroy C, White DR, Dubin M, Senior B. A comparison of computer-aided surgery registration methods for endoscopic sinus surgery. Am J Rhinol. 2006 Jan-Feb;20(1):48-52.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Xiao_owen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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