Biomechanical optimization of the ossicular chain prostheses using 3D-printing and PCL/nHA nanocomposite for middle ear reconstruction

Current ossicular prostheses are limited by conventional designs and materials, leading to variable surgical outcomes. This study introduces a novel, integrated VSim-3P workflow that synergizes VSP, FEA, EMA, 3D printing, and casting to establish a proof-of-concept platform for personalized middle ear reconstruction. PCL/nHA nanocomposite was synthesized by the solvent casting method and characterized by FESEM, EDS, XRD, and TGA. The tensile test revealed an increase in Young’s modulus of the PCL/nHA in comparison with PCL. PCL/nHA and PCL were utilized to fabricate patient-specific, anatomically accurate ossicles derived directly from clinical CT data through a combination of MSLA and casting methods. Computational FEA and experimental EMA were used to evaluate biomechanical performance. EMA revealed consistent vibrational patterns within each specimen group, including total OC constructs and human malleus/incus with prosthetic stapes. FEA systematically compared anatomical and conventional designs across multiple materials under various discontinuity scenarios. A novel multi-metric ranking system, integrating DTW, RMSE, and Pearson correlation with Benjamini–Hochberg correction, identified six high-performing prostheses (IAP-Titanium, IAP-PCL, SAP-PCL, SAP-Titanium, SAP-PCL/nHA, and IAP-PCL/nHA) as most closely replicating natural ossicular vibration. FEA demonstrated that the mechanical role of ossicular ligaments profoundly influences prosthesis performance, a factor often overlooked in explaining variability in clinical outcomes. This study underscores the importance of patient-specific design and material optimization to achieve near-native middle ear performance. Among the materials investigated, PCL/nHA emerged as a particularly promising candidate, combining favorable biomechanical characteristics with biological properties including osteoconductivity, cell adhesion, and potential for osseointegration, making it well-suited for next-generation ossicular chain prostheses.