Outcomes of Zygomatic Fractures: Cross- Sectional Study

NCT06476340 | Not Yet Recruiting

• 1 other identifier: ErasmusMC_2
• Study Type: observational
• Target: 126
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Zygoma Fracture

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Interventions

No intervention OTHER

None, questionnaires/CBCT/3D photography/physical examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Zygomatic Fractures

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Central Study Contacts

Antoinette Rozeboom

CONTACT

0624984936; a.rozeboom@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share