Clinical trial NCT03075384: Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System
Official title: Application of Computer-Assisted Navigation System in the Treatment of Unilateral Complicated Zygomatic Complex Fractures: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Zygomatic Fractures
Keywords: computer-assisted navigation system
Lead sponsor: West China College of Stomatology
Sponsor class: OTHER
Collaborators: name: West China College of Stomatology
First posted: 2017-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with unilateral complicated zygomatic-complex fractures

Brief 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. The aim of this study was to evaluate the accuracy of the computer-assisted navigation system by a randomized controlled trial with multiple variables.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: accuracy of the reduction of the fractures
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Oral & Maxillofacial Surgery, West China Hospital of Stomatology, Sichuan University
name: Lei Liu, DMD
role: STUDY_DIRECTOR
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