Influence of gamma-irradiation sterilization and temperature on the fracture toughness of ultra-high-molecular-weight polyethylene

Surface damage of the tibial plateau components of knee prostheses made from medical grade ultrahigh-molecular-weight polyethylene (UHMW-PE) has been attributed to delamination wear caused by a fatigue fracture mechanism. It has been proposed that factors such as component design and method of sterilization contribute to such failure mechanisms. Understanding the fracture behaviour of UHMW-PE is therefore critical in optimizing the in vivo life-span of total joint components. The elastic-plastic fracture toughness parameter J was consequently determined for a commercial UHMW-PE at ambient and body temperatures, before and after gamma-irradiation sterilization in air at a minimum dose of 25 kGy. Both ductile stability theory and experimental data suggest that cracks propagate in a stable manner, although stability is affected by the sterilization process. Sterilization with gamma-irradiation results in a loss in fracture toughness J(lc) of 50% and a decrease in tearing modulus (T-m) of 30%. This dramatic reduction could result in a 50% decrease in the residual strength of the components, maximum permissible crack size under service loading and service life (assuming flaws such as fusion defects exist). The time required for a crack to grow from its original size to the maximum permissible size could be decreased by 30%, resulting in earlier failure. In terms of the design of joint replacement components the critical factor to envisage is the design stress level, which should be halved to account for the irradiation process. A scanning electron microscope study reveals that the material fails in layers parallel to the fracture surface. (C) 1997 Elsevier Science Limited.