Finite Element and One Point Fixation

December 27, 2023 updated by: Shaimaa Mohsen, Fayoum University

Role of Finite Element Analysis for Selection of Single Point Fixation in Zygomaticomaxillary Complex Fracture

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Fit to general anesthesia (GA)
  • Isolated minimally displaced zygomaticomaxillary complex (ZMC) fracture

Exclusion Criteria:

  • absence of other facial trauma, mandibular condylar fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: finite arm
Procedure: Zygomaticomaxillary fracture repair

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stresses by megapascal (MPa)
Time Frame: immediately after procedure
stress on the plate will be measured for each point of application by finite element (FA) software
immediately after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-OS-2-23-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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