BoneTape: A novel osteosynthetic device for the stabilization of zygomatic fractures

Background: The study aims to assess the safety and effectiveness of BoneTapem`, a new resorbable bone fixation device, using a zygomatic fracture model in rabbits. Methods: The study followed BoneTapem` samples and control (sham) groups over 2-, 6-, and 12week periods post-zygomaticomaxillary (ZM) osteotomy and zygomaticofrontal (ZF) disarticulation. The osteotomized segments were analyzed for bone healing, inflammatory response, and tissue healing. mu CT imaging and histological analysis were used to examine the axial alignment, offset, and quality of new bone formation. Results: BoneTapem` samples demonstrated enhanced maintenance of the initial intraoperative positioning, reduced axial offset, and better alignment when compared with the control group, enabling stable bone healing under physiological loading conditions. Complete union was observed at 12-weeks in both groups. The BoneTapem` group experienced minimal immune and tissue reactions, classically associated with wound healing, and showed an increased number of giant cells at 6 and 12-weeks. Conclusion: BoneTapem` represents a promising advancement in osteosynthesis, demonstrating efficacy in maintaining stable zygomatic reconstruction and eliciting minimal immune response in a rabbit model. This study introduces BoneTapem` as a disruptive solution specifically designed for clinical application in cranio -maxillofacial fracture fixation, with the potential to eliminate the use of over -engineered solutions while offering benefits such as ease of appli - cation and fewer biologically disruptive steps. (c) 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.