Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

Not Applicable

• Conditions: Zygomatic Fractures
• Interventions: Device: Titinium

• Registration Number: NCT03484676
• Lead Sponsor: Cairo University

Brief Summary

Patients with unilateral non-comminuted zygomatic complex fracture undergo fixation of the complex by a customized plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Detailed Description

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 Timeline

• Status Verified: 2018-03
• Study Start: 2018-03
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-25
• Last Update Submitted: 2018-03-25
• Study First Posted: 2018-04-02
• Last Update Posted: 2018-04-02
• Primary Completion: 2018-07
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patients' age range from 15-65 years.
• Patients with unilateral zygomatic complex fracture
• Displaced fracture
• Dentulous or edentulous patients.
• Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).

• Patients with comminuted fractures .
• Delayed presentation 3 weeks or more after the date of trauma.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unilateral Non comminuted zygomatic complex fracture	Titinium	Patient undergo treatment no control group

Primary Outcome Measures

Name	Time	Method
Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10	One week	Esthetics and function of patient return post operative. Normal

Secondary Outcome Measures

Name	Time	Method
Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters	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