Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture
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|ClinicalTrials.gov Identifier: NCT03484676|
Recruitment Status : Not yet recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Zygomatic Fractures||Device: Titinium||Not Applicable|
History data will be gathered including personal data, medical and surgical history, and family history.
Clinical examination and photographic records will be carried out to evaluate the magnitude and direction of the displaced zygoma, degree of facial asymmetry, neurosensory affection and functional disturbances.
Computed tomography (CT) scan:
Patients will receive a preoperative computed tomography (CT) scan of the facial bones [ Axial cuts, DICOM file, Gantry tilt zero and minimal thickness of 1 mm]. The radiographic data will be imported into a surgical simulation software to virtually reduce the fractured zygoma and custom design the plate for fixation.
General operative procedures:
- All cases will undergo surgery under general anesthesia with nasotracheal intubation.
- Intraoral maxillary vestibular approach will be used to gain access to the fractured zygomatic complex. Reduction of the fractured segment would be achieved using the appropriate techniques and instrumentation. One point ORIF would be accomplished using the customized plate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2018|
Unilateral Non comminuted zygomatic complex fracture
Patient undergo treatment no control group
custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
- Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10 [ Time Frame: One week ]Esthetics and function of patient return post operative. Normal
- Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters [ Time Frame: Immediately post operative ]Reduction of fracture on mimics soft ware depending on 3d virtual simulation and mirror image of the same patient and after operation I will compare post operative reduction to preoperative reduction on mimics soft ware in millimeters measuring unit