Study Design. A validated L3–L4 nonlinear finite element model was used to evaluate strain and pressure in the surrounding structures for 4 nucleus replacement technologies.
Objective. The objective of the current study was to compare subsidence and anular damage potential between 4 current nucleus replacement technologies. It was hypothesized that a fully conforming nucleus replacement would minimize the risk of both subsidence and anular damage.
Summary of Background Data. Nucleus pulposus replacements are emerging as a less invasive alternative to total disc replacement and fusion as a solution to degenerative intervertebral discs. Multiple technologies have been developed and are currently undergoing clinical investigation.
Methods. The testing conditions were applied by excavating the nucleus of the intact model and virtually implanting models representing the various nucleus replacement technologies. The implants consisted of a conforming injectable polyurethane (E = 4 MPa), soft hydrogel (E = 4 MPa), stiff hydrogel (E = 20 MPa), and polyether-etherketone (PEEK) on PEEK articulating designs. The model was exercised in flexion, extension, lateral bending, axial rotation (7.5 Nm with 450 N preload), and compression (1000 N). Vertebral body strain, anular maximum shear strain, endplate contact pressure, anulus-implant contact pressure, and bone remodeling stimulus were reported.
Results. The PEEK implant induced strain maxima in the vertebral bodies with associated endplate contact pressure concentrations. For the PEEK and hydrogel implants, areas of nonconformity with the endplate indicatedadjacent bone resorption. Lack of conformity between the implant and inner anulus for the PEEK and hydrogel implants resulted in inward anular bulging with associated increased maximum shear strain. The conforming polyurethane implant maintained outward bulging of the inner anular wall and indicated no bone resorption or stress shielding adjacent to the implant.
Conclusion. A fully conforming nucleus replacement resulted in a decreased propensity for subsidence, anular bulging, and further degeneration of the anulus when compared with nonconforming implants.