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Finite Element Role in Zygomaticomaxillary Complex (ZMC) Fracture

Primary Purpose

Zygomaticomaxillary Complex Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Zygomaticomaxillary fracture repair
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zygomaticomaxillary Complex Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fit to general anesthesia (GA) Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture Exclusion Criteria: absence of other facial trauma, mandibular condylar fracture

Sites / Locations

  • Tanta universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

finite arm

Arm Description

Outcomes

Primary Outcome Measures

Stresses by megapascal (MPa)
stress on the plate will be measured for each point of application by finite element (FA) software

Secondary Outcome Measures

Full Information

First Posted
March 24, 2023
Last Updated
April 18, 2023
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT05819372
Brief Title
Finite Element Role in Zygomaticomaxillary Complex (ZMC) Fracture
Official Title
Role of Finite Element Analysis for Selection of Single Point Fixation in Zygomaticomaxillary Complex Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum 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
A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of ZMC 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which point of fixation is the best After application this point of fixation on the patient Finite element analysis will be done again to verify the previous results

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zygomaticomaxillary Complex Fracture

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
finite arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Zygomaticomaxillary fracture repair
Intervention Description
A cone beam CT (CBCT) scan of the patient will be used to create a 3D scanned image of zygomaticomaxillary complex fracture (ZMC) 3D images will be introduced to finite element (FA) software to evaluate Stresses (MPa), Micromotion (microns), and Life time (cycle) For each model and determine which point of fixation is the best After application this point of fixation on the patient Finite element analysis will be done again to verify the previous results
Primary Outcome Measure Information:
Title
Stresses by megapascal (MPa)
Description
stress on the plate will be measured for each point of application by finite element (FA) software
Time Frame
immediately after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fit to general anesthesia (GA) Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture Exclusion Criteria: absence of other facial trauma, mandibular condylar fracture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaimaa Refahee, phd
Phone
01227407987
Email
smr11@fayoum.edu.eg
Facility Information:
Facility Name
Tanta university
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shaimaa refahee, phd
Phone
01227407987
Email
smr11@fayoum.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Finite Element Role in Zygomaticomaxillary Complex (ZMC) Fracture

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