Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

Zygomatic Fractures Clinical Trial

Official title:

Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03484676
• Other study ID #: CEBD-CU-2018-03-17
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 25, 2018
• Start date: March 2018
• Est. completion date: October 2018

Study information

• Verified date: March 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: October 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Zygomatic Fractures

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10	Esthetics and function of patient return post operative. Normal	One week
Secondary	Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters	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	Immediately post operative