Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

Cairo University (CU)

Status: Unknown

Conditions: Zygomatic Fractures

Treatments: Device: Titinium

Study type: Interventional

Funder types: Other

Identifiers

NCT03484676

CEBD-CU-2018-03-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Unilateral Non comminuted zygomatic complex fracture

Other group

Description:

Patient undergo treatment no control group

Treatment:

Device: Titinium