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Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

Primary Purpose

Zygomatic Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Titinium
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zygomatic Fractures

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Unilateral Non comminuted zygomatic complex fracture

    Arm Description

    Patient undergo treatment no control group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    March 13, 2018
    Last Updated
    March 25, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03484676
    Brief Title
    Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture
    Official Title
    Adequacy of One-Point Fixation of Displaced Zygomatic Complex Fractures Using a Customized Plate pre_post Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Zygomatic Fractures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Unilateral Non comminuted zygomatic complex fracture
    Arm Type
    Other
    Arm Description
    Patient undergo treatment no control group
    Intervention Type
    Device
    Intervention Name(s)
    Titinium
    Intervention Description
    custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
    Primary Outcome Measure Information:
    Title
    Patient satisfaction. Measuring device visual analogue scale. Measuring unit 0-10
    Description
    Esthetics and function of patient return post operative. Normal
    Time Frame
    One week
    Secondary Outcome Measure Information:
    Title
    Adequacy of reduction compared to the preoperative virtual simulation measuring device mimics software Ware. Measuring unit millimeters
    Description
    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
    Time Frame
    Immediately post operative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture

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