Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

NCT ID: NCT03484676

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-31
• Study Completion Date: 2018-10-31

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.

Conditions

Zygomatic Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unilateral Non comminuted zygomatic complex fracture

Patient undergo treatment no control group

Group Type: OTHER

Titinium

Intervention Type: DEVICE

custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Interventions

Titinium

custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ashour Saad Borma

Internal resident at Maxillofacial department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CEBD-CU-2018-03-17

Identifier Type: -

Identifier Source: org_study_id