Sensitivity of Lumbar Total Joint Replacement Contact Stresses Under Misalignment Conditions-Finite Element Analysis of a Spine Wear Simulator.

A novel total joint replacement (TJR) that treats lumbar spine degeneration was previously assessed under Mode I and Mode IV conditions. In this study, we relied on these previous wear tests to establish a relationship between finite element model (FEM)-based bearing stresses and in vitro wear penetration maps. Our modeling effort addressed the following question of interest: Under reasonably worst-case misaligned conditions, do the lumbar total joint replacement (L-TJR) polyethylene stresses and strains remain below values associated with Mode IV impingement wear tests? The FEM was first formally verified and validated using the risk-informed credibility assessment framework established by ASME V&V 40 and FDA guidance. Then, based on criteria for unreasonable misuse outlined in the surgical technique guide, a parametric analysis of reasonably worst-case misalignment using the validated L-TJR FEM was performed. Reasonable misalignment was created by altering device positioning from the baseline condition in three scenarios: Axial Plane Convergence (20-40°), Axial Plane A-P Offset (0-4 mm), and Coronal Plane Tilt (±20°). We found that, for the scenarios considered, the contact pressures, von Mises stresses, and effective strains of the L-TJR-bearing surfaces remained consistent with Mode I (clean) conditions. Specifically, the mechanical response values fell below those determined under Mode IV (worst-case) boundary conditions, which provided the upper-bound benchmarks for the study (peak contact pressure 83.3 MPa, peak von Mises stress 32.2 MPa, and peak effective strain 42%). The L-TJR was judged to be insensitive to axial and coronal misalignment under the in vitro boundary conditions imposed by the study.