Zygoma Fracture

This study aims to evaluate the safety, effectiveness, and usability of BoneTape, an innovative medical device designed to fix facial bone fractures, specifically in the zygomaticomaxillary (midface) region. Zygomaticomaxillary fractures, often caused by trauma like car accidents or falls, require surgery to align and stabilize the bones for proper healing. Traditional methods use metal plates and screws, which can be complicated to install, over-engineered for the area, and may lead to complications, requiring additional surgeries. BoneTape is a new, resorbable (biodegradable) device that offers a simpler, potentially safer alternative. Unlike traditional metal hardware, BoneTape is a flexible, thin plate that can be easily cut to the required shape during surgery and applied directly to the bone using a special tool that anchors it without needing to drill or screw holes. This process significantly simplifies the surgical procedure, reduces the time needed for fixation, and avoids complications associated with drilling into healthy bone tissue. Study Objectives: Feasibility: Determine if BoneTape can be successfully used to stabilize midfacial fractures. Effectiveness: Assess the ability of BoneTape to help bones heal properly without additional complications. Safety: Monitor and evaluate any adverse events related to the use of BoneTape. Study Design: The study is designed as a single-arm, cohort study. Participants will undergo baseline pre-operative assessments, including clinical exams, CT scans, and pain questionnaires. BoneTape will be applied during surgery, and post-operative assessments will take place within 24 hours. Follow-up visits will occur at 1 week, 6 weeks, 24 weeks, and 12 months to monitor the healing process, assess pain levels, and check for any adverse events. Eligibility Criteria: Inclusion: Adults with a unilateral, non-comminuted (not broken into multiple pieces) zygomaticomaxillary fracture requiring surgery. Must be skeletally mature, able and willing to attend follow-up visits, and provide informed consent. Exclusion: Patients with critically sized bone defects, fractures requiring orbital floor surgery, pregnancy, certain medical conditions impairing bone healing, or those unwilling or unable to follow the study procedures. Study Duration: The total study duration is expected to be 21-24 months, including the 12-month follow-up period for each participant. Outcome Measures: The primary outcomes include the feasibility of the procedure (successful use of BoneTape without additional hardware), early effectiveness (bone healing and stability at 6 and 24 weeks), and safety (rate and type of adverse events up to 24 weeks). Secondary outcomes will assess long-term safety and effectiveness at 12 months, patient-reported outcomes on pain, and physician feedback on device usability. This study is a critical step in evaluating BoneTape as a potential alternative to current facial bone fixation methods, potentially improving surgical outcomes and patient quality of life by reducing the complexity of procedures and minimizing the need for additional surgeries.

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.