Personalized postoperative management and physical therapy enabled by sensorized bone plates for traumatic fractures.

PROJECT SUMMARY/ABSTRACT Distal femoral fractures (DFF) are associated with high complication and mortality rates. The prevalence of DFF has increased in the last twenty years, predominately in elderly patients with an incidence of 27.4 per 100,000 in the United States. Despite advancements in orthopedic technology, the rate of nonunion, defined as fracture that persists for over 9 months without signs of healing, are persistently high at approximately 10-14% for these fractures. This complication is associated with increased cost, morbidity and revision surgeries. In the geriatric DFF population, 1-year mortality rates, due to complications from DFFs, remain high at approximately 25%. Optimization in treatment of DFF should be viewed as a critical public health concern, yet the optimal treatment of these fractures are highly dependent on individuals and conditions. Research indicates that maintaining a 2-10% strain environment promotes fracture healing, while strains outside this range can lead to nonunion. Therefore, a technology to track local strains during surgery and throughout postoperative rehabilitation would enable evidence-based treatment and potentially improve clinical outcomes. The objective of this project is to fabricate and characterize a DFF fixation plate that features an implantable, battery-free, wireless sensor for intra- and postoperative monitoring of fixation plate strains to provide personalized, quantitative readouts used to inform the surgery and subsequent rehabilitation. For patients progressing within the advantageous 2-10% strain window, our sensor would enable faster advancement through rehabilitative exercises, minimizing recovery time and associated healthcare costs. Conversely, for patients with strains outside this window, our sensor could identify these individuals as “at-risk” before postoperative complications occur, allowing earlier interventions and thus reducing reoperation rates. Furthermore, this technology could revolutionize the understanding of how loading mechanics impact bone healing and provide objective, continuous data to aid surgeons in the optimal treatment of DFF. The insight gleaned from this technology could also improve the standard of care for other weight-bearing bones. The diverse mentorship team for this project will provide the technical expertise, clinical insight, and entrepreneurial guidance to make this technology a reality while also supporting PI Williams’ career development. Williams is highly qualified for the SBIR New Entrepreneur award because (1) her technology can reduce DFF complications, a public health concern; (2) she has assembled a diverse mentoring team of experts in their field to aid in the design, validation, and commercialization of her sensor; (3) she has the business training and technical expertise needed for successful execution of the proposed work; and (4) completion of this award will aid in her career transition and her long term career goal to be in a high-level, decision-making position in the medical industry to drive the conversion of research into impactful medical products. Williams has worked with her mentoring team for years and is excited to leverage their expertise to guide her independent transition as the new Clinical Engineering Director at Penderia Technologies Inc. and to support future funding efforts such as SBIR Phase II and beyond.