Mechanical Characterization of a Viscoelastic Disc for Lumbar Total Disc Replacement

Abstract

A viscoelastic artificial disc may more closely replicate normal stiffness characteristics of the healthy human disc compared with first-generation total disc replacement (TDR) devices, which do not utilize viscoelastic materials and are based on a ball and socket design that does not allow loading compliance. Mechanical testing was performed to characterize the durability and range of motion (ROM) of an investigational viscoelastic TDR (VTDR) device for the lumbar spine, the Freedom® Lumbar Disc. ROM data were compared with data reported for the human lumbar disc in the clinical literature. Flexibility and stiffness of the VTDR in compression, rotation, and flexion/extension were within the parameters associated with the normal human lumbar disc. The device constrained motion to physiologic ranges and replicated normal stress/strain dynamics. No mechanical or functional failures occurred within the loads and ROM experienced by the human disc. Fatigue testing of the worst case VTDR device size demonstrated a fatigue life of 50 years of simulated walking and 240 years of simulated significant bends in both flexion/extension and lateral bending coupled with axial rotation, with no functional failures. These results indicate that the VTDR evaluated in this mechanical study is durable and has the ability to replicate the stiffness and mechanics of the natural, healthy human lumbar disc.