Processing, Annealing and Sterilisation of Poly-L-Lactide.

Poly--lactide (PLLA) is one of the most significant members of a group of polymers regarded as bioabsorbable. Degradation of PLLA proceeds through hydrolysis of the ester bonds in the polymer chains and is influenced significantly by the polymer's molecular weight and crystallinity. To evaluate the effects of processing and sterilisation on these properties, PLLA pellets were either compression moulded or extruded, subjected to annealing at 120°C for 4 h and sterilised by ethylene oxide (EtO) gas. Procedures were used to evaluate the mechanical properties, molecular weight and crystallinity. Upon processing, the crystallinity of the material fell from 61% for the PLLA pellets to 12% and 20% for the compressed and extruded components, respectively. After annealing, crystallinity increased to 43% for the compression-moulded material and 40% for the extruded material. Crystallinity further increased upon EtO sterilisation. A slight decrease in molecular weight was observed for the extruded material through processing, annealing and sterilisation. Young's modulus generally increased with increasing crystallinity, and extension at break and tensile strength decreased. The results from this investigation suggest that PLLA is sensitive to processing and sterilisation, altering properties critical to its degradation rate.

The Influence of Inert Packaging on the shelf Ageing of Gamma-Irradiation Sterilised ultra-high molecular weight polyethylene

Ultra-high molecular weight polyethylene (UHMWPE) is used for wear applications in total hip prostheses and total knee prostheses. Sterilisation of these prostheses is commonly by gamma-irradiation. This process creates reactive free radicals in the UHMWPE, greatly increasing its susceptibility to oxidative degradation. This study has investigated the influence of air and vacuum packaging on the properties of gamma-irradiated UHMWPE (GUR1050) following 3 years of shelf ageing. The findings indicate that vacuum packaging minimises oxidative degradation reactions that occur for UHMWPE during shelf ageing. However, gamma-irradiation of vacuum-packaged UHMWPE promotes a degree of cross-linking. It is proposed that this may enhance the wear performance of UHMWPE. Accelerated ageing studies indicate that 3 years of shelf ageing would also seem to reduce the susceptibility of gamma-irradiated UHMWPE to oxidative degradation upon removal from its vacuum packaging.

Microabrasion : A novel method to assess surface degradation of UHMWPE following sterilisation and ageing

The ageing behaviour of ultra-high molecular weight polyethylene (UHMWPE) has been studied following gamma irradiation (25 or 40 kGy) in air. Accelerated ageing procedures used elevated temperature (70°C) and/or pressurised oxygen (5 bar). Shelf-aged UHMWPE was also studied. The variation in surface density and mechanical properties were determined following the various sterilisation and ageing treatments. Microabrasive wear testing was also performed. Wear rates were found to correlate well with stress at break for sterilised and aged UHMWPE but not with elongation to failure. It is proposed that the wear mechanism is fracture dominated and occurs following some disentanglement of the polymer chains. Wear also depends upon embrittlement of the surface layer due to its processing and ageing. Elongation to failure in a tensile test is not a good measure of this embrittlement whereas the microabrasion test provides more surface sensitive information concerning this property.

Cancellous bone repair using bovine trabecular bone matrix particulates.

At 5 and 15 weeks post-surgery, biomechanical and histological analyses of cancellous bone defects filled with the bovine trabecular bone matrix (BBM) and hydroxyapatite (Hap) particulates of dimensions 106–150 µm were investigated. It was observed that at 5 weeks post-surgery the stiffness properties of the BBM filled defects were significantly higher than those observed in the Hap filled defects (p