Examination of an in vitro methodology to evaluate the biomechanical performance of nucleus augmentation in axial...

Intervertebral disc degeneration is one of the leading causes of back pain, but treatment options remain limited. Recently, there have been advances in the development of biomaterials for nucleus augmentation; however, the testing of such materials preclinically has proved challenging. The aim of this study was to develop methods for fabricating and testing bone-disc-bone specimens in vitro for examining the performance of nucleus augmentation procedures. Control, nucleotomy and treated intervertebral disc specimens were fabricated and tested under static load. The nucleus was removed from nucleotomy specimens using a trans-endplate approach with a bone plug used to restore bony integrity. Specimen-specific finite element models were developed to elucidate the reasons for the variations observed between control specimens. Although the computational models predicted a statistically significant difference between the healthy and nucleotomy groups, the differences found experimentally were not significantly different. This is likely due to variations in the material properties, hydration and level of annular collapse. The deformation of the bone was also found to be non-negligible. The study provides a framework for the development of testing protocols for nucleus augmentation materials and highlights the need to control disc hydration and the length of bone retained to reduce inter-specimen variability.