- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05819372
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
-
-
-
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
|
A cone beam CT (CBCT) scan of the patient will be used to create a 3D scanned image of zygomaticomaxillary complex fracture (ZMC)
|
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
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.