BoneTape for Cheekbone Fractures
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the BoneTape trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if your medications could impair bone healing, you might be excluded from the study.
What data supports the effectiveness of the treatment BoneTape for cheekbone fractures?
The research suggests that using techniques like bone grafting and fixation methods, such as resorbable plates and tappers, can be effective in treating facial bone fractures. These methods have shown good cosmetic and functional outcomes in similar cases, indicating that BoneTape might also be effective for cheekbone fractures.12345
How does the treatment BoneTape differ from other treatments for cheekbone fractures?
BoneTape is unique because it likely involves a novel method for holding and stabilizing fractured bone segments, potentially using a tapper device that simplifies the surgical process by minimizing issues with holding bone fragments before fixation. This approach may offer advantages over traditional methods like mini-fragment bone plates or intermaxillary fixation screw traction wires, which are used for stabilizing facial bone fractures.24678
Eligibility Criteria
This trial is for adults with a specific type of cheekbone fracture that requires surgery but isn't shattered into multiple pieces. Participants must be fully grown, able to come back for follow-ups, and give informed consent. It's not for those with very large bone gaps, fractures needing additional orbital floor surgery, pregnant individuals, people with conditions affecting bone healing or who can't follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
BoneTape is applied during surgery to stabilize midfacial fractures
Follow-up
Participants are monitored for healing process, pain levels, and adverse events
Treatment Details
Interventions
- BoneTape
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cohesys Inc.
Lead Sponsor