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Zygomatic FracturesNCT03075384

Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System

An observational study of Zygomatic Fractures, run by Xiao Zhang.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many studies show that computer-assisted navigation system have been available to treat zygomatic-complex fractures. However, most of them are case reports or clinical experiences lacking multiple variables and controlled design. Read more about this study

Who is it for?
Ages 18 to 58 years
Conditions the study is for
Zygomatic Fractures
What is being tested?
computer-assisted navigation system
Type of treatment
Surgery or procedure
How many people
20 participants
Where
No sites listed yet
Study dates
Mar 2014to Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 58 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: patients with unilateral complicated zygomatic-complex fractures

Who may be able to join

  • 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

Who cannot join

  • 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.

About this study

Official title: Application of Computer-Assisted Navigation System in the Treatment of Unilateral Complicated Zygomatic Complex Fractures: A Randomized Controlled Trial

Many studies show that computer-assisted navigation system have been available to treat zygomatic-complex fractures. However, most of them are case reports or clinical experiences lacking multiple variables and controlled design. The aim of this study was to evaluate the accuracy of the computer-assisted navigation system by a randomized controlled trial with multiple variables.

Read the 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.

Being tested
computer-assisted navigation system
Keywords
computer-assisted navigation system
Medical subject headings
Zygomatic Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • computer-assisted navigation systemProcedure or surgery

    The computer-assisted navigation system was applied in treatment of unilateral complicated zygomatic fractures

Study groups in NCT03075384
Study groupRoleWhat they receive
open reduction and internal fixationA classic method was used to treat unilateral complicated zygomatic fractures without the assistance of computer-assisted navigation system
Receives: Procedure: computer-assisted navigation system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. accuracy of the reduction of the fractures

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2017
  2. Study startMar 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03075384
Sponsor's protocol ID
Xiao_owen
Status last verified
Mar 2017
First submitted
4 Mar 2017
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22212823

  • 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.

    PubMed 20677370

  • 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.

    PubMed 22497773

  • 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.

    PubMed 26770280

  • 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.

    PubMed 20006151

  • 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.

    PubMed 12777923

  • 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.

    PubMed 19375007

  • 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.

    PubMed 27441035

  • 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.

    PubMed 21050633

  • 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.

    PubMed 17003608

  • 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.

    PubMed 17903581

  • 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.

    PubMed 23714993

  • 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.

    PubMed 21185639

  • 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.

    PubMed 8600255

  • 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.

    PubMed 27733307

Questions about this trial

What is this clinical trial studying?

An observational study of Zygomatic Fractures, run by Xiao Zhang.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy of the reduction of the fractures (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03075384, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.

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