Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476340
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-21
Brief Title:
Outcomes of Zygomatic Fractures Cross- Sectional Study
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Outcomes of Zygomatic Fractures Cross- Sectional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZY-PROM
Brief Summary:
Rationale Facial trauma is a significant event for patients often resulting in physical and psychological consequences Fractures in the zygomatic bone area are common due to its unique shape and positioning in the face disrupting facial symmetry and impacting aesthetics functionality and psychological well-being The zygomatic bone crucial for facial contour and support is associated with complications such as diplopia sensory disturbances and mastication problems when fractured Treatment aims to restore function aesthetics and prevent long-term deformities Despite surgical and imaging advancements postoperative complications like residual deformity and dissatisfaction persist Even with achieved bone symmetry patients may perceive asymmetry Current literature emphasizes the need for future symmetry analyses to include both soft and hard tissues
Objective This study aims to evaluate the long-term outcomes of zygomatic fracture treatments at Erasmus MC from 2008 to 2023
Study design Cross-sectional study Study population The study population consists of adult patients aged 18 years and above diagnosed with zygomatic fractures and treated at Erasmus MC Rotterdam between 2008 and 2023
Intervention Not applicable Main study parametersendpoints The primary endpoint is patient satisfaction and quality of life
Nature and extent of the burden and risks associated with participation benefit and group relatedness Cone Beam Computed Tomography CBCT is an advanced imaging modality utilized for high-resolution three-dimensional 3D visualization of the maxillofacial region It employs a rotating C-arm apparatus to project a cone-shaped X-ray beam through the patients head yielding detailed images with minimal distortion CBCT is pivotal in the diagnosis and assessment of maxillofacial conditions including zygomatic fractures while ensuring low radiation exposure Over the past two decades CBCT has been extensively integrated into dental and maxillofacial imaging with numerous studies substantiating its efficacy and safety in clinical contexts It serves as a cornerstone in orthodontic implantological and trauma evaluation supported by a substantial body of evidence validating its ability to delineate bone structures and identify fractures Human exposure to CBCT has demonstrated a robust safety profile characterized by radiation doses lower than those of conventional CT scans thus imparting negligible additional risk
Objective This study aims to evaluate the long-term outcomes of zygomatic fracture treatments at Erasmus MC from 2008 to 2023
Study design Cross-sectional study Study population The study population consists of adult patients aged 18 years and above diagnosed with zygomatic fractures and treated at Erasmus MC Rotterdam between 2008 and 2023
Intervention Not applicable Main study parametersendpoints The primary endpoint is patient satisfaction and quality of life
Nature and extent of the burden and risks associated with participation benefit and group relatedness Cone Beam Computed Tomography CBCT is an advanced imaging modality utilized for high-resolution three-dimensional 3D visualization of the maxillofacial region It employs a rotating C-arm apparatus to project a cone-shaped X-ray beam through the patients head yielding detailed images with minimal distortion CBCT is pivotal in the diagnosis and assessment of maxillofacial conditions including zygomatic fractures while ensuring low radiation exposure Over the past two decades CBCT has been extensively integrated into dental and maxillofacial imaging with numerous studies substantiating its efficacy and safety in clinical contexts It serves as a cornerstone in orthodontic implantological and trauma evaluation supported by a substantial body of evidence validating its ability to delineate bone structures and identify fractures Human exposure to CBCT has demonstrated a robust safety profile characterized by radiation doses lower than those of conventional CT scans thus imparting negligible additional risk
Detailed Description:
1 INTRODUCTION AND RATIONALE
Facial trauma represents a significant event in a patients life often resulting in physical deformities and potential psychological consequences 1 2 In facial trauma cases fractures occurring in the zygomatic bone area are prevalent due to the distinctive shape and positioning within the face 3 4 These fractures can disrupt the facial symmetry which plays a role in the perceived aesthetics and functionality of the human face impacting not only physical appearance but also psychological well-being and social interactions 5
The zygomatic bone a critical component of the midfacial skeleton contributes to the contour and width of the face supports the orbit and has a functional role as the origin of one of the masticatory muscles the masseter muscle 6 Therefore fractures in this region can lead to a variety of complications including diplopia enophthalmos sensory disturbances and mastication problems 7 Treatment aims not only to restore function and aesthetics but also to prevent long-term deformities
Despite advancements in surgical techniques and imaging modalities 8 postoperative complications such as residual deformity asymmetry of hard and soft tissue and dissatisfaction with facial appearance remain remain concerns that warrant further investigation Even when bone symmetry is achieved patients may still report perceived asymmetry 9 Current literature primarily focused on hard tissue symmetry indicates the necessity of including both soft and hard tissues in future symmetry analyses 10
This study aims to create a detailed database of patients treated for zygomatic fractures at Erasmus MC from 2008 to June 2023 By leveraging data from electronic patient records we intend to gather extensive demographic clinical and treatment-related information Following this patients will be invited to undergo additional evaluations including Cone Beam Computed Tomography CBCT scans which offer precise imaging to assess for any residual displacement and asymmetry For soft tissue 3D facial photography will be used to objectively measure facial asymmetry offering a comprehensive view of both functional and aesthetic results post-recovery Patient satisfaction and quality of life post-treatment will be assessed through validated questionnaires FACE-Q providing insights into the psychological and social impacts of these injuries Functional tests will be conducted to evaluate ocular motility and cutaneous sensory function
Through this multifaceted approach the study aims to identify factors contributing to optimal outcomes and those that may predispose patients to poorer prognoses The findings will not only enhance understanding of zygomatic fractures but also inform future clinical practices ensuring improved patient care and satisfaction through better expectation management
2 OBJECTIVES
Primary Objective
The primary objective of this study is to evaluate the long-term outcomes of patients treated for zygomatic fractures at Erasmus MC from 2008 to 2023 Specifically to assess patient satisfaction with facial appearance and overall quality of life post-treatment using validated questionnaires This will provide insights into the psychological and social impacts of zygomatic fractures and their treatment
Secondary Objectives
Residual displacement and asymmetry A secondary objective is to assess the degree of residual displacement and asymmetry in both hard and soft tissues using Cone Beam Computed Tomography CBCT scans and 3D facial photography This evaluation will determine the effectiveness of current surgical techniques in restoring facial symmetry and function
Functional Outcomes
To evaluate the functional outcomes of the surgical treatment including ocular motility range of motionmouthopening cutaneous sensory function These tests will help determine the success of the treatment in restoring normal facial function
Facial trauma represents a significant event in a patients life often resulting in physical deformities and potential psychological consequences 1 2 In facial trauma cases fractures occurring in the zygomatic bone area are prevalent due to the distinctive shape and positioning within the face 3 4 These fractures can disrupt the facial symmetry which plays a role in the perceived aesthetics and functionality of the human face impacting not only physical appearance but also psychological well-being and social interactions 5
The zygomatic bone a critical component of the midfacial skeleton contributes to the contour and width of the face supports the orbit and has a functional role as the origin of one of the masticatory muscles the masseter muscle 6 Therefore fractures in this region can lead to a variety of complications including diplopia enophthalmos sensory disturbances and mastication problems 7 Treatment aims not only to restore function and aesthetics but also to prevent long-term deformities
Despite advancements in surgical techniques and imaging modalities 8 postoperative complications such as residual deformity asymmetry of hard and soft tissue and dissatisfaction with facial appearance remain remain concerns that warrant further investigation Even when bone symmetry is achieved patients may still report perceived asymmetry 9 Current literature primarily focused on hard tissue symmetry indicates the necessity of including both soft and hard tissues in future symmetry analyses 10
This study aims to create a detailed database of patients treated for zygomatic fractures at Erasmus MC from 2008 to June 2023 By leveraging data from electronic patient records we intend to gather extensive demographic clinical and treatment-related information Following this patients will be invited to undergo additional evaluations including Cone Beam Computed Tomography CBCT scans which offer precise imaging to assess for any residual displacement and asymmetry For soft tissue 3D facial photography will be used to objectively measure facial asymmetry offering a comprehensive view of both functional and aesthetic results post-recovery Patient satisfaction and quality of life post-treatment will be assessed through validated questionnaires FACE-Q providing insights into the psychological and social impacts of these injuries Functional tests will be conducted to evaluate ocular motility and cutaneous sensory function
Through this multifaceted approach the study aims to identify factors contributing to optimal outcomes and those that may predispose patients to poorer prognoses The findings will not only enhance understanding of zygomatic fractures but also inform future clinical practices ensuring improved patient care and satisfaction through better expectation management
2 OBJECTIVES
Primary Objective
The primary objective of this study is to evaluate the long-term outcomes of patients treated for zygomatic fractures at Erasmus MC from 2008 to 2023 Specifically to assess patient satisfaction with facial appearance and overall quality of life post-treatment using validated questionnaires This will provide insights into the psychological and social impacts of zygomatic fractures and their treatment
Secondary Objectives
Residual displacement and asymmetry A secondary objective is to assess the degree of residual displacement and asymmetry in both hard and soft tissues using Cone Beam Computed Tomography CBCT scans and 3D facial photography This evaluation will determine the effectiveness of current surgical techniques in restoring facial symmetry and function
Functional Outcomes
To evaluate the functional outcomes of the surgical treatment including ocular motility range of motionmouthopening cutaneous sensory function These tests will help determine the success of the treatment in restoring normal facial function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None