BoneTape Feasibility 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.