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
About this trial
This is an interventional treatment trial for Zygomatic Fractures
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.
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
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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