Zygoma FractureZY-PROMNCT06476340
Outcomes of Zygomatic Fractures: Cross- Sectional Study
An observational study of Zygoma Fracture, run by Erasmus Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Zygoma Fracture
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Aug 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients who sustained a zygomatic fracture and were treated at Erasmus MC from January 2008 to June 2023.
- Patients aged 18 years and older at the time of the initial treatment.
Who cannot join
- Patients with incomplete or missing electronic medical records that lack essential demographic, clinical, or treatment-related information.
- Subsequent facial trauma: Patients who experienced additional facial trauma after the initial zygomatic fracture, which could affect the outcomes and complicate the assessment of the initial treatment.
- Zygoma arch fracture: Patients who have a zygomatic arch fracture. This will nog influence the asymmetry or physical appearance.
- Psychiatric or cognitive disorders: Patients with psychiatric or cognitive disorders that impair their ability to provide informed consent or complete the necessary fol-low-up evaluations and questionnaires.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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 parameters/endpoints: 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 patient's 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.
Read the detailed description
- INTRODUCTION AND RATIONALE Facial trauma represents a significant event in a patient's 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.
- 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 Objective(s):
- 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 motion/mouthopening, cutaneous sensory function. These tests will help determine the success of the treatment in restoring normal facial function.
- Conditions
- Zygoma Fracture
- Being tested
- No intervention
- Medical subject headings
- Zygomatic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
None, questionnaires/CBCT/3D photography/physical examination
What is being measured
The primary outcome is the main question the study is designed to answer.
PROM face Q
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygoma FractureStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antoinette V. J. Rozeboom, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476340
- Sponsor's protocol ID
- ErasmusMC_2
- Acronym
- ZY-PROM
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Zygomatic Fractures: Cross- Sectional Study
- ClinicalTrials.gov ID
- NCT06476340
- Acronym / sponsor ID
- ZY-PROM / ErasmusMC_2
- Conditions
- Zygoma Fracture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 parameters/endpoints: 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 patient's 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
- INTRODUCTION AND RATIONALE Facial trauma represents a significant event in a patient's 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.
- 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 Objective(s):
- 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 motion/mouthopening, cutaneous sensory function. These tests will help determine the success of the treatment in restoring normal facial function.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who sustained a zygomatic fracture and were treated at Erasmus MC from January 2008 to June 2023.
- Patients aged 18 years and older at the time of the initial treatment.
Key exclusion criteria (4 listed)
- Patients with incomplete or missing electronic medical records that lack essential demographic, clinical, or treatment-related information.
- Subsequent facial trauma: Patients who experienced additional facial trauma after the initial zygomatic fracture, which could affect the outcomes and complicate the assessment of the initial treatment.
- Zygoma arch fracture: Patients who have a zygomatic arch fracture. This will nog influence the asymmetry or physical appearance.
- Psychiatric or cognitive disorders: Patients with psychiatric or cognitive disorders that impair their ability to provide informed consent or complete the necessary fol-low-up evaluations and questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNone, questionnaires/CBCT/3D photography/physical examination | Other | – |
Primary outcome
PROM face Q
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Zygoma Fracture, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoinette Rozeboom (0624984936, a.rozeboom@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROM face Q (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.