When reversing the hard-soft articulation in inverse shoulder replacement, i.e. hard inlay and soft glenosphere (cf. Figure 1), the tribological behaviour of such a pairing has to be tested thoroughly. Therefore, two hard materials for the inlay, CoCr alloy and alumina toughened zirconia ceramic (ceramys®) articulating on two soft materials, conventional UHMWPE and vitamin E stabilised, highly cross-linked PE (vitamys®) were tested in a joint simulator. The simulator tests were performed at Endolab GmbH, Rosenheim, Germany, analogue to standardised gravimetric wear tests for hip prosthesis (ISO 14242-1) with load and motion curves adapted to the shoulder. The test parameters differing from the standard were the maximum force (1.0 kN) and the range of motion. A servo-hydraulic six station joint simulator (EndoLab) was used to run the tests up to 5*106 cycles with diluted calf serum at 37° C as lubricant. Visual inspection and mass measurements were done at 0.1, 0.5, 1, 2, 3, 4 and 5 million cycles using a high precision scale and a stereo microscope, respectivly.Background
Methods
Malpositioning still occurs in total hip arthroplasty (THA). As a result of mal-orientation, THA bearing can be subjected to edge loading. The main objective of the study was to assess if the wear rate of ceramic-on-ceramic and metal-on-polyethylene increases under edge loading conditions and to determine which of the most commonly used hip bearings is the most forgiving to implant mal-orientation. Two different polyethylenes (UHMWPE and vitamin E blended HXLPE) and ceramics (pure aluminum PAL and alumina-toughened zirconia ATZ) were tested with a hip simulator and compared to metal-on-metal results. The inclination angle was selected at 45°, 65° and 80°. In addition, the ceramic-on-ceramic barings were tested at conditions that produced microseparation. Contrary to metal-on-metal that is highly susceptible to edge loading, the wear rate of ceramic-on-ceramic and metal-on-polyethylene articulations does not increase with increasing cup inclination. In fact, the polyethylenes showed a contra-intuitive behaviour as its wear rate decreased slightly but significantly with increasing inclination angle. This behaviour can be explained when looking closely at the contact stresses and areas. (Figure 1 shows the wear area of the vitamin E blended HXLPE at 45° and figure 2 at 80° cup inclination). The newest biomaterials, vitamin E blended HXLPE and ATZ, showed markedly lower wear rates compared to their conventional counterparts, UHMWPE and PAL. The ATZ ceramic-on-ceramic articulation showed the lowest wear rate (even when microseparation is included) of all tested pairings, but the new vitamin-doped HXLPE seems to be the most forgiving materials when it comes to implant mal-orientation. It shows low wear rate even at an extremely high cup inclination angle. Therefore, a surgeon that discovers a mal-positioned polyethylene cup at the first post-op X-ray will not need to worry unduly about increased wear (but “only” about a potential dislocation).Materials and methods
Results
Ceramic composites have been developed to further improve the mechanical properties, reduce risk of fracture, and increase the survivorship of ceramic-on-ceramic bearings in total hip replacement1. The aim of this study was to evaluate the wear of two novel ceramic composite materials under edge loading conditions due to translational mal-positioning when used in both like-on-like and mixed pairing configurations; and to compare their performance to earlier generation ceramic-on-ceramic bearings. The head-on-cup configurations of three ceramic materials (see Figure 1), were ATZ-on-ATZ, ZTA-on-ZTA, Al2O3-on-Al2O3, ATZ-on-ZTA, ZTA-on-ATZ, Al2O3-on-ATZ, ATZ-on-Al2O3and Al2O3-on-ZTA. All combinations were size 28mm and were supplied by Mathys Orthopädie GmbH (Morsdorf, Germany). They were tested for four million cycles on the Leeds II hip simulator under microseparation2,3,4 conditions representing translational mal-positioning. The gait cycle comprised extension/flexion (−15º/+30º), internal external rotation (+/−10º) and a twin peak load with a maximum of 3kN. Microseparation was achieved by applying a 0.5mm dynamic medial/lateral displacement using a spring load resulting in edge loading at heel strike. New-born calf serum (25%) was used as a lubricant. Wear was assessed gravimetrically every million cycles. Statistical analysis was performed using one-way ANOVA (significance taken at p<0.05).Introduction
Materials and Methods
Edge loading in acetabular hip implants is generally due to mal-orientation or low tissue tension. It is known that edge loading of metal-on-metal THA may lead to higher metal wear and ion release with corresponding adverse body reactions. The inclination angle of the acetabular cup has been positively correlated with the wear rate of explanted components 1. However, no data published is known about wear rates of edge loaded hard – soft hip bearings. For the hip simulator study, seleXys cup inlays, size 28/EE, (Mathys Ltd Bettlach, Switzerland) were used. Standard PE parts and vitamys® inlays (highly cross-linked, vitamin E stabilised UHMWPE) were tested in the same run. PE inlays were machined out of sintered GUR 1020 slabs, packaged and gamma-sterilised in inert atmosphere at 30 kGy. The vitamys® material was made in-house by adding 0.1 wt.-% of vitamin E to GUR 1020 powder from Ticona GmbH, Kelsterbach/Germany. Cross-linking used 100 (±10) kGy gamma-irradiation and the final sterilisation was gas plasma. Cup inclination was varied: besides the protocol of ISO 14242-1 with an inclination angle corresponding to 45 ° in the medial-lateral plane, a steep cup position corresponding to 75 ° was tested, too. To our knowledge, this is the highest inclination angle ever tested in a hip simulator. The testing was conducted in a servo-hydraulic six-station hip simulator (Endolab, Thansau/Rosenheim, Germany) at a temperature of 37±1°C. Tests were run at the RMS Foundation (Bettlach / Switzerland) for five million cycles. The test fluid was based on bovine serum diluted to a protein concentration of 30 g/l and stabilised with sodium azide and EDTA. At lubricant change interval of 500,000 cycles, the inlays were measured gravimetrically with an accuracy of 0.01 mg.Introduction
Methods
The introduction of a new implant material is not without risk. A series of worst-case scenarios were developed and tested accordingly to answer questions such as: what will happen if the implant is not placed in a good orientation? What will happen to the material after a long implantation time, e.g. 20 or more years? To reach a higher level of safety, a new approach for the preclinical testing has been taken. The vitamys® material (a novel vitamin-doped HXLPE) followed a severe pre-clinical testing protocol, including mechanical, tribological and biocompatibility testing. The testing includes a comparison of vitamys® vs. standard-UHMWPE and other HXLPE after accelerated ageing for periods equivalent to 20 and 40 years in-vivo. Hip simulator testing was done at inclination angles from 35° to 65° to assess the “forgiveness” of the material for mal-orientation. Comparing the test results to published data, it becomes evident that the vitamin addition and the sequence of the manufacturing steps both have a significant effect of the resulting mechanical, ageing and wear properties. In contrast to UHMWPE or HXLPE without antioxidant, the vitamys material behaves in a very “forgiving” manner: Hip simulator testing of vitamys at high inclination angles and even with severely aged material revealed no increase of wear rates. The vitamys material was first introduced in a monoblock polyethylene cup with a thin Ti-particle coating, the RM-Pressfit vitamys® acetabular cup (Mathys Ltd Bettlach, Switzerland). Its first implantation occurred in Sept. 2009. Since then, a total of nearly 500 implantations have been documented in a prospective multi-centre clinical study involving 11 clinics in 5 countries (CH, DE, FR, NL and NZ). Based on the pre-clinical testing and its first clinical experience, we have reason to believe that the RM-Pressfit vitamys® possesses interesting and unique features such as high elasticity (no stress-shielding), high ageing and wear resistance combined with clinically proven biological anchorage – making it theoretically suitable for a whole range of patients, including the young and active.
