Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03484676
Recruitment Status : Not yet recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Information provided by (Responsible Party):
Ahmed Ashour Saad Borma, 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.

Condition or disease Intervention/treatment Phase
Zygomatic Fractures Device: Titinium Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Unilateral Non comminuted zygomatic complex fracture
Patient undergo treatment no control group
Device: Titinium
custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.

Primary Outcome Measures :
  1. Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10 [ Time Frame: One week ]
    Esthetics and function of patient return post operative. Normal

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Ahmed Ashour Saad Borma, Internal resident at Maxillofacial department, Cairo University Identifier: NCT03484676     History of Changes
Other Study ID Numbers: CEBD-CU-2018-03-17
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Zygomatic Fractures
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures