Introduction. Vitamin E stabilization of radiation crosslinked UHMWPE is done by (1) blending into the resin powder, consolidating and irradiating or (2) diffusing into already consolidated and irradiated UHMWPE and terminally gamma sterilizing. With blending, a higher radiation dose is required for crosslinking to the same level as virgin UHMWPE. With diffusion, the vitamin E amount used is not limited by the crosslink density, but, vitamin E is exposed to terminal sterilization dose of 25–40 kGy, less than the 100–150 kGy used with blending, which may decrease the grafting of the antioxidant onto the polymer. We investigated the efficiency of grafted vitamin E against squlene-initiated accelerated aging. Methods. Medical grade GUR1050 UHMWPE with vitamin E (0.1 wt%) was irradiated to 150 kGy. Tibial knee insert preforms were irradiated to 100 kGy, diffused with vitamin E using a doping and homogenization procedure. This UHMWPE was used either before or after gamma sterilization. One set of machined blocks (10 × 10 × 6 mm; n = 6) were extracted in boiling hexane for 4 days, then dried. The extracted blocks were doped with squalene at 120°C for 2 hours. One block each was analyzed after doping. The rest were accelerated aged at 70°C and 5 atm. of oxygen for 6 (n = 2) and 14 days (n = 3). Thin sections (150 micron thick) were microtomed and analyzed by Fourier Transform Infrared Spectroscopy to determine a vitamin E index (1245–1275 cm. −1. normalized to 1850–1985 cm. −1. ) and an oxidation index (1700 cm. −1. normalized to 1370 cm. −1. ) after extraction with boiling hexane for 16 hours and drying. Results. After extraction, 92% of the original vitamin E was removed from diffused and sterilized UHMWPE and 99% of the vitamin E was removed from the diffused and unsterilized UHMWPE. Vitamin E content of the blended, irradiated UHMWPEs could not be detected. As a result of accelerated aging in the presence of squalene, all extracted vitamin E-stabilized UHMWPEs showed increased oxidation except diffused, sterilized UHMWPE. The small amount grafted vitamin E in these samples (8%, ∼0.02 wt%) protected irradiated UHMWPE under these conditions. All vitamin E-stabilized, extracted UHMWPEs showed higher oxidative stability than irradiated and melted virgin UHMWPE in the presence of squalene. In the blended, irradiated UHMWPE, there was less effective vitamin E compared to the diffused, sterilized UHMWPE due to the high dose irradiation. Conclusions. Radiation grafting of vitamin E onto UHMWPE was effective against squalene initiated oxidation in accelerated aging. Vitamin E-diffused, sterilized UHMWPE showed no oxidation and diffused, unsterilized UHMWPE and blended, irradiated UHMWPE showed higher oxidative resistance than irradiated/melted UHMWPE

Recent findings about UHMWPE oxidation from in vivo stresses lead to the need of a better understanding of which anti-oxidant additivation method is the best option for the use in orthopaedic field. A GUR 1050 crosslinked Vitamin E - blended UHMWPE has been investigated, to provide an accurate outline of its properties. DSC and FTIR measurements, together with ageing and tensile tests were performed on compression moulded blocks, as well as biocompatibility tests, including implantation on rabbits. Moreover, wear simulations on finished components (Delta acetabular liners) have been completed. All the test procedures have been repeated for a reference material, a GUR 1050 crosslinked and remelted standard UHMWPE (commercial name UHMWPE X-Lima), and the outcomes have been compared to the crosslinked Vitamin E - blended UHMWPE ones. On the additivated UHMWPE, we found a ultimate tensile strength of 43 MPa, a yield strength value of 25 MPa, and an elongation to breakage equal to 320%. The degree of cristallinity was 45 ± 2%, and no signal of creation of oxidation products was detected up to 2000 h of permanence in oxidant ambient after the ageing test. The reference material showed comparable mechanical resistance values (∗ = 40 MPa, y = 20 MPa, 350% elongation), a cristallinity of 46 ± 2%, and the creation of oxidation products starting from 700 h in oxidant ambient. The biocompatibility tests indicate that the additivated material is biocompatible, as the reference X-Lima UHMWPE. Wear tests gave a wear rate of 5,09 mg/million cycles against 6,13 mg/million cycles of the reference material, and no sign of run in wear rate. Our results indicate that there is no change in mechanical properties in respect to the reference material. This is confirmed by DSC measurements, that show no change in cristallinity. The blend between polymer and additive assures an uniform concentration of Vitamin E across the whole thickness of the moulded block, and ageing test results on additivated UHMWPE have shown that the material possess a superior resistance to degradation phenomena. Biocompatibility assess that the presence of Vitamin E is not detrimental for the in vivo use of the material, and wear results indicate a better wear resistance of the material, especially in the first stages of the wear process. From these considerations, it can be concluded that the material, in respect to the standard UHMWPE, is highly resistant to oxidation phenomena, therefore it is expected to have superior in vivo endurance performance

INTRODUCTION. The lifetime of UHMWPE implants may be limited by wear and oxidative degeneration. Wear produced particles are in general biologically active, and may induce osteolysis. As threshold of PE wear rate below which osteolysis is rarely observed is postulated to be less tahn 0.1 mm per year. Moreover, PE delamination and breakage are consequences of the embrittlement of the PE due to oxidation. Both demonstrate, that improving the clinical behaviour of UHMWPE means reduction of wear particles. The first can be achieved by cross-linking the second by the anti-oxidative stabiliser vitamin E. The highly cross-linked PE vitamys ® used for the isoelastic monobloc cup RM Pressfit (Mathys AG Bettlach, Bettlach, Switzerland) is mixed with 0.1% of synthetic vitamin E and is the first and only highly cross-linked PE used in total hip replacement that meets all requirements for the best grade UHMWPE in yield strength, ultimate tensile strength and elongation at break. METHODS AND MATERIAL. With the first implantation of RM Pressfit vitamys® a prospective multicentre study was started. So far 256 cases in 7 clinics from Europe and New Zealand are included. This report presents the first clinical experiences of one Swiss clinic from the multicentre study. Prospective data collection includes Harris Hip score (HHS), patient satisfaction and radiographic analysis. Clinical and radiographic follow-up is done after 6 weeks, 6, 12 and 24 months, and thereafter for long-term results. Standardized documentation of surgery and postoperative course is performed. RESULTS. 81 patients were included in the study. Mean age at implantation is 69 years. The indication was primary OA in 57% and secondary OA in 36%, the others were treated either for necrosis, fracture or hip dysplasia. 68% of the patients received a 36mm femoral head, 31% a 32mm and 1% a 28mm. Intraoperatively two minor complications occurred, one femur and one trochanter fissure. No complications occurred during implantation of the cup. Most of the cups (59%) were implanted with an inclination of 40°-50°, 30% with 35°-40°. There were no signs of early loosening and a good Harris Hip Score was achieved. DISCUSSION. The principals of this monobloc cup with its isoelastic property and the thin titanium coating is a proven concept. Ihle et al. (JBJS 2008) reported 91% survival rate with revision for aseptic loosening as endpoint after 20 years. They found an increase of cup revisions after 14 to 16 years after implantation due to osteolysis probably due to PE wear. At short term, we haven't encountered any problems related to the implantation of this cup. So far one patient in the entire multicentre study needed a stem revision after periprosthetic femur fracture. To prove the durability of this novel material a follow-up of 14 years and more will be required

Introduction. Cobalt chrome on polyethylene remains a widely used bearing combination in total joint replacement. However wear induced osteolysis, bulk material property degradation of highly cross-linked polyethylene (HXLPE) [1], and oxidation after implantation (thought to be as a result of lipid absorption or cyclic loading [2]) remains a concern. ECIMA is a cold-irradiated, mechanically annealed, vitamin E blended next generation HXLPE developed to maintain mechanical properties, minimise wear and to improve the oxidation resistance in the long-term. The aim of this study was to compare the in-vitro wear rate and mechanical properties of three different acetabular liners; conventional UHMWPE, HXLPE and ECIMA. Methods. Twelve liners (Corin, UK) underwent a 3 million cycle (mc) hip simulation. Three conventional UHMWPE liners (GUR1050, Ø32 mm, 30 kGy sterilised in Nitrogen), three HXLPE liners (GUR1020, Ø40 mm, 75 kGy cross-linking and EtO sterilised) and six ECIMA liners (0.1 wt% vitamin E GUR1020, Ø40 mm, 120 kGy cross-linking, mechanically deformed and annealed, and EtO sterilised) articulated against CoCrMo alloy femoral heads to ASTM F75 (Corin, UK). Wear testing was performed in accordance with ISO 14242 parts 1 and 2, with a maximum force of 3.0 kN and at a frequency of 1 Hz. The test lubricant used was calf serum with a protein content of 30 g/l and 1% (v/v) patricin added as an antibacterial agent. Volumetric wear rate was determined gravimetrically after the first 0.5 mc and every 1 mc thereafter. ASTM D638 type V specimens (3.2 mm thick) were machined from ECIMA material for uniaxial tension testing to ASTM D638. Ultimate tensile strength (UTS), yield strength and elongation values were measured. These values were compared to mechanical data available for the other material types. Results. There was a 94% and a 68% reduction in the wear rate for the ECIMA liners compared to the conventional UHMWPE and HXLPE liners respectively. There was an increase in UTS, yield strength and elongation of 11%, 11% and 15% respectively, for ECIMA compared to HXLPE. Discussion. The wear results reported in this study indicate that ECIMA is a very low wearing material which has the potential to reduce wear related osteolysis in-vivo. Importantly, the mechanical properties were generally maintained unlike the degradation found in many modified polyethylene materials and were more comparable to conventional UHMWPE than HXLPE. The reduced wear rate during in-vitro hip simulation of ECIMA compared to conventional UHMWPE, coupled with improved mechanical properties in comparison to HXLPE, makes ECIMA a promising next generation, advanced bearing material