An observational study in Zygomatic Fractures, sponsored by Xiao Zhang. Completed. Open to participants aged 18 Years to 58 Years. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Xiao Zhang · Observational
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with Xiao Zhang as lead sponsor.
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patients with unilateral complicated zygomatic-complex fractures
Exclusion Criteria:
A classic method was used to treat unilateral complicated zygomatic fractures without the assistance of computer-assisted navigation system
Procedure: computer-assisted navigation system
The computer-assisted navigation system was applied in treatment of unilateral complicated zygomatic fractures
accuracy of the reduction of the fractures
Time frame: one year
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Zygomatic Fractures