Ceramic-on-ceramic (CoC) bearings in total hip replacements (THRs) have shown low wear volumes under standard gait in hip simulator studies. However, clinical reports have indicated variations in wear rates and formation of stripe-like wear area on the ceramic femoral heads. The aim of this study was to investigate the influence of cup inclination angle and microseparation on the wear of CoC bearings in THRs. The six station Leeds II Physiological Anatomical Joint Simulator was used to investigate the wear of 28 mm diameter alumina matrix composite ceramic bearings (BIOLOX® delta). It was shown that increasing the cup inclination angle from 55° to 65° had no significant effect on the wear rate of BIOLOX® delta CoC under both standard gait and microseparation conditions in this in vitro study. Under standard gait conditions, the mean wear rate for both cup inclination angle conditions was very low at 0.05 mm(3)/million cycles. The introduction of microseparation to the standard gait cycle increased the mean wear rates to 0.13 mm(3)/million cycles for the cup inclination angle of 55° and 0.11 mm(3)/million cycles for that of 65°. The level of increased wear with microseparation was not dependent on cup angle. A stripe of wear on the head also formed, with corresponding superior rim wear on the cup. The wear rates obtained were low compared to the HIPed third generation alumina ceramic (BIOLOX® forte) tested under the same adverse conditions (1.84 mm(3)/million cycles). BIOLOX® delta has shown lower wear than previous ceramic materials used in THR under adverse conditions.

Metal-on-metal (MoM) bearings have shown low-wear rates under standard hip simulator conditions; however, retrieval studies have shown large variations in wear rates and mechanisms. High-wear in vivo has caused catastrophic complications and has been associated with steep cup-inclination angle (rotational malpositioning). However, increasing the cup-inclination angle in vitro has not replicated the increases in wear to the same extent as those observed in retrievals. Clinically relevant wear rates, patterns, and particles were observed in vitro for ceramic-on-ceramic bearings when microseparation (translational malpositioning) conditions were introduced into the gait cycle. In the present study, 28 and 36-mm MoM bearings were investigated under adverse conditions. Increasing the cup angle from 45° to 65° resulted in a significant increase in the wear rate of the 28 mm bearings. However, for the 36 mm bearings, head-rim contact did not occur under the steep cup-angle condition, and the wear rate did not increase. The introduction of microseparation to the gait cycle significantly increased the wear rate of the MoM bearings. Cup angle and head size did not influence the wear rate under microseparation conditions. This study indicated that high-in vivo wear rates were associated with edge loading due to rotational malpositioning such as high-cup-inclination angle and translational malpositioning that could occur due to several surgical factors. Translational malpositioning had a more dominant effect on the wear rate. Preclinical simulation testing should be undertaken with translational and rotational malpositioning conditions as well as standard walking cycle conditions defined by the ISO standard. © 2012 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2013.

Ceramic-on-ceramic bearings have become of great interest due to the substantial improvements in the manufacturing techniques and material properties and due to polyethylene wear debris-induced osteolysis and the issues with metal wear debris and ion release by metal-on-metal bearings. Edge loading conditions due to translational malpositioning (microseparation conditions) have been shown to replicate clinically relevant wear mechanisms and increase the wear of ceramic-on-ceramic bearings; thus, it was necessary to test new bearing materials and designs under these adverse conditions. The aim of this study was to assess the effect of increasing head size on the wear of BIOLOX(®) delta ceramic-on-ceramic bearings under edge loading conditions due to rotational (steep cup inclination angle) and translational (microseparation) malpositioning. In this study, six 36-mm ceramic-on-ceramic bearings (BIOLOX delta, CeramTec, Germany) were tested under standard and edge loading conditions using the Leeds II hip simulator and compared to the 28-mm bearings tested and published previously under identical conditions. The mean wear rate under standard gait conditions was below 0.1 mm(3)/million cycles for both the 28-mm and the 36-mm ceramic-on-ceramic bearings, and increasing the inclination angle did not affect the wear rates. The introduction of microseparation to the gait cycle increased the wear rate of ceramic-on-ceramic bearing and resulted in stripe wear on the femoral heads. Under microseparation conditions, the wear rate of size 36-mm bearings (0.22 mm(3)/million cycles) was significantly higher (p = 0.004) than that for size 28-mm bearings (0.13 mm(3)/million cycles). This was due to the larger contact area for the larger bearings and deprived lubrication under edge loading conditions. The wear rate of BIOLOX delta ceramic-on-ceramic bearings under microseparation conditions was still very low (<0.25 mm(3)/million cycles) compared to earlier generation ceramic-on-ceramic bearings (BIOLOX forte, 1.84 mm(3)/million cycles) and other bearing materials such as metal-on-metal bearings (2-8 mm(3)/million cycles).

Further development of ceramic materials for total hip replacement aim to increase fracture toughness and further reduce the incidence of bearing fracture. Edge loading due to translational mal positioning (microseparation) has replicated stripe wear, wear rates, and bimodal wear debris observed on retrievals. This method has replicated the fracture of early zirconia ceramic-on-ceramic bearings. This has shown the necessity of introducing microseparation conditions to the gait cycle when assessing the tribological performance of new hip replacement bearings. Two novel ceramic matrix composite materials, zirconia-toughened alumina (ZTA) and alumina-toughened zirconia (ATZ), were developed by Mathys Orthop€ adie GmbH. In this study, ATZon-ATZ and ZTA-on-ZTA bearing combinations were tested and compared with alumina-on-alumina (Al 2 O 3 -on-Al 2 O 3 ) bearings under adverse microseparation and edge loading conditions using the Leeds II physiological anatomical hip joint simulator. The wear rate (695% confidence limit) of ZTA-on-ZTA was 0.14 6 0.10 mm 3 /million cycles and that of ATZ-on-ATZ was 0.06 6 0.004 mm 3 /million cycles compared with a wear rate of 0.74 6 1.73 mm 3 /million cycles for Al 2 O 3 -on-Al 2 O 3 bearings. Stripe wear was evident on all bearing combinations; however, the stripe formed on the ATZ and ZTA femoral heads was thinner and shallower that that formed on the Al 2 O 3 heads. Posttest phase composition measurements for both ATZ and ZTA materials showed no significant change in the monoclinic zirconia content. ATZon-ATZ and ZTA-on-ZTA showed superior wear resistance properties when compared with Al 2 O 3 -on-Al 2 O 3 under adverse edge loading conditions.

A new Stratified Approach For Enhanced Reliability (SAFER) pre-clinical simulation testing of joint prostheses is presented in this article. The aim of this approach is preclinical systematic testing of wear performance in the much wider envelope of conditions found clinically rather than relying only on the standard testing conditions that are currently used. The approach includes variations in surgical delivery, variations in kinematics, variations in the patient population and degradation of the biomaterial properties. Clinical experience of existing prostheses has been used to validate the new in vitro methods.

Ceramic-on-metal (COM) hip replacements, where the head is BIOLOX® Delta ceramic and the liner is CoCrMo alloy, have demonstrated reduced wear under standard simulator conditions compared to metal-on-metal (MOM) bearings. COM hips are now being used clinically around the world. MOM hip resurfacings have raised concerns regarding poor clinical performance and increased in vivo wear was associated with steeply inclined acetabular components and translationally malpositioned components. The aim of this study was to compare the wear rates of MOM and COM total hip prostheses under adverse edge-loading conditions in a hip simulator test. COM and MOM 36 mm hip prostheses were tested in a hip simulator, with liners mounted to provide a clinical inclination angle of 55°. A simplified gait cycle and microseparation conditions were applied for two million cycles in 25% new born calf serum. The overall mean volumetric wear rate of COM bearings under adverse conditions was 0.36 ± 0.55 mm³/million cycles; this was significantly less than MOM wear (1.32 ± 0.91 mm³/million cycles). Under these adverse conditions; the contact zone on the head intersects the rim of the cup causing substantially elevated contact stresses, disrupting the protective boundary and mixed lubrication regime causing changes in types and severity of wear mechanisms. In COM bearings, the harder head does not become damaged when there is lubricant starvation and wear does not accelerate. In conclusion, COM bearings showed reduced wear compared to MOM bearings under standard and adverse clinically relevant simulator conditions and COM bearings may provide an advantage over MOM bearings under edge-loading conditions clinically.

The aim of this study was to develop a preclinical in vitro method to predict the occurrence and severity of edge loading condition associated with the dynamic separation of the centres of the head and cup (in the absence of impingement) for variations in surgical positioning of the cup. Specifically, this study investigated the effect of both the variations in the medial–lateral translational mismatch between the centres of the femoral head and acetabular cup and the variations in the cup inclination angles on the occurrence and magnitude of the dynamic separation, the severity of edge loading, and the wear rate of ceramic‐on‐ceramic hip replacement bearings in a multi‐station hip joint simulator during a walking gait cycle. An increased mismatch between the centres of rotation of the femoral head and acetabular cup resulted in an increased level of dynamic separation and an increase in the severity of edge loading condition which led to increased wear rate in ceramic‐on‐ceramic bearings. Additionally for a given translational mismatch, an increase in the cup inclination angle gave rise to increased dynamic separation, worst edge loading conditions, and increased wear. To reduce the occurrence and severity of edge loading, the relative positions (the mismatch) of the centres of rotation of the head and the cup should be considered alongside the rotational position of the acetabular cup. This study has considered the combination of mechanical and tribological factors for the first time in the medial–lateral axis only, involving one rotational angle (inclination) and one translational mismatch. © 2017 The Authors Journal of Biomedical Materials Research Part B: Applied Biomaterials Published by Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1897–1906, 2018.

Wear and fatigue of polyethylene acetabular cups have been reported to play a role in the failure of total hip replacements. Hip simulator testing under a wide range of clinically relevant loading conditions is important. Edge loading of hip replacements can occur following impingement under extreme activities and can also occur during normal gait, where there is an offset deficiency and/or joint laxity. This study evaluated a hip simulator method that assessed wear and damage in polyethylene acetabular liners that were subjected to edge loading. The liners tested to evaluate the method were a currently manufactured crosslinked polyethylene acetabular liner and an aged conventional polyethylene acetabular liner. The acetabular liners were tested for 5 million standard walking cycles and following this 5 million walking cycles with edge loading. Edge loading conditions represented a separation of the centers of rotation of the femoral head and the acetabular liner during the swing phase, leading to loading of the liner rim on heel strike. Rim damage and cracking was observed in the aged conventional polyethylene liner. Steady-state wear rates assessed gravimetrically were lower under edge loading compared to standard loading. This study supports previous clinical findings that edge loading may cause rim cracking in liners, where component positioning is suboptimal or where material degradation is present. The simulation method developed has the potential to be used in the future to test the effect of aging and different levels of severity of edge loading on a range of cross-linked polyethylene materials. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 1456-1462, 2018.