A methodology for constructing and assessing a combined experimental and computational validation domain for...

Area of Science:

• Biomedical Engineering
• Materials Science
• Computational Mechanics

Background:

• Preclinical assessment of patient-specific mandibular reconstruction plates lacks structured methods for mechanical relevance.
• Existing bench testing and computational modeling setups are often designed practically, not clinically.

Purpose of the Study:

• To propose and demonstrate a methodology for creating a validation domain for patient-specific fibula free flap mandibular reconstruction.
• To ensure the mechanical relevance of preclinical assessments to the clinical context of use (COU).

Main Methods:

• Developed a clinical reference finite element model (M-COU) of the reconstructed mandible under clenching.
• Used M-COU to derive a validation setup with a physical platform (R-VAL) and computational model (M-VAL).
• Employed analytical calibration and design-of-experiments for parameter refinement.

Main Results:

• The M-VAL model achieved high consistency with M-COU (R²=0.75), outperforming benchmarks (R²=0.27, 0.40).
• The setup preserved clinically relevant stress distribution at the mandibular angle.
• M-VAL and R-VAL showed close agreement in stiffness (0.6% difference) and strain distribution (R²=0.93).

Conclusions:

• The proposed methodology offers a transferable framework for creating mechanically interpretable and clinically relevant validation domains.
• This approach enhances the preclinical assessment of patient-specific mandibular reconstruction plates.
• The framework ensures experimental feasibility while maintaining fidelity to the clinical COU.