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410 Improving Patient Outcomes through Design of Biodegradable Implants for Long Bone Fractures

Published online by Cambridge University Press:  03 April 2024

Justin S. Unger
Affiliation:
Institute for Clinical and Translational Research, Johns Hopkins University School of Medicine; Department of Civil and Systems Engineering, Johns Hopkins University
Timothy P. Weihs
Affiliation:
Department of Materials Science and Engineering, Johns Hopkins University
James K. Guest
Affiliation:
Department of Civil and Systems Engineering, Johns Hopkins University
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Abstract

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OBJECTIVES/GOALS: Current long bone fracture standard of care uses inert metal intramedullary nails (IMN), 10x stiffer than femur cortex. Consequent “stress-shielding” bone loss sees >5% of patients needing revision surgery. To improve nonunion healing, we develop automated design optimization methods for biodegradable Mg alloy IMNs to control local reloading. METHODS/STUDY POPULATION: Finite element analysis (FEA) is performed on 3D bone-IMN representations to establish this study’s baseline strain states for existing inert IMN geometries within QCT-informed femoral models under simulated biomechanical loading. FEA with Mg alloy properties for same IMN designs simulate transient IMN material loss through discrete time-step models with experimental in vivo Mg corrosion rates and strain-based bone density evolution using remodeling algorithms from literature. Transient stability and strength metrics, fracture zone stress profiles under gradual reloading and manufacturing constraints are formulated through gradient-based sensitivity analysis into a topology optimization framework (TOF) incorporating a reaction-diffusion degradation model to generate IMN topologies. RESULTS/ANTICIPATED RESULTS: TOF designs for Mg alloy IMNs with transient allowable strength constraints, using safety factors to prevent IMN failure, demonstrate higher compliance than standard inert IMNs with mechanical properties closer to native cortical bone. The biodegradation model within the TOF, informed by corrosion behavior from bone-IMN FEA study, predicts how potential design evolutions affect transient strain states of the system. Thus, local fracture region stress states are controlled by the algorithm optimizing for desirable transient stiffness profiles based on a minimum variance objective of fracture zone stress compared to a target bone stress profile. Optimized IMNs with porous, high surface area features achieve 50% decrease in IMN stiffness over 6 months recovery time and complete in vivo degradation in 24 months. DISCUSSION/SIGNIFICANCE: Our TOF reduces “stress-shielding” effects via design for controlled IMN biodegradation to gradually increase fracture zone loading, stimulating remodeling and reducing current risk of post-operative fracture and surgical removal in ~15k cases/yr. in the U.S. In vitro mechanical and in vivo clinical testing is required to validate design results.

Type
Precision Medicine/Health
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s), 2024. The Association for Clinical and Translational Science