Wear particles produced by alumina ceramic-on-ceramic (CoC) bearings cause a minimal immunological response with low cytotoxicity and inflammatory potential^{1, 2}. However, more comprehensive immunological studies are yet to be completed for the composite CoC (zirconia-toughened, platelet reinforced alumina) hip replacements due to difficulties in isolating the very low volume of clinically relevant wear debris generated by such materials in vitro. The aim of this study was to compare the cytotoxic effects of clinically relevant cobalt chromium (CoCr) nano-particles with commercial composite ceramic particles.

Composite ceramic particles (commercial BIOLOX® delta powder) were obtained from CeramTec, Germany and clinically relevant CoCr wear particles were generated using a six station pin-on-plate wear simulator. L929 fibroblast cells were cultured with 50µm³ of CoCr wear debris or composite ceramic particles at low to high volumes ranging from 500µm³–0.5µm³ per cell and the cyctotoxic effects of the particles were assessed over a period of 6 days using the ATP-Lite™ cell viability assay.

The composite ceramic particles were bimodal in size (0.1–2µm & 30–100nm) and showed mild cytotoxic effects when compared with equivalent particle volumes (50µm³) of clinically relevant CoCr nano-particles (10–120nm). The CoCr nano-particles had significant cytotoxic effects from day 1, whereas the composite ceramic particles only showed cytotoxic effects at particle concentrations of 50 and 500µm³ after 6 days. The increased cytotoxicity of the clinically relevant CoCr nano-particles may have been attributed to the release of Co and Cr ions.

This study demonstrated the potential cytotoxic effects of model ceramic particles at very high volume concentrations, but it is unlikely that such high particle volumes will be experienced routinely in vivo in such low wearing bearing materials. Future work will investigate the longer-term effects on genotoxicity and oxidative stress of low volumes of clinically-relevant generated BIOLOX® delta ceramic wear particles.

Surgical interventions for the treatment of chronic neck pain, which affects 330 million people globally [1], include fusion and cervical total disc replacement (CTDR). Most of the currently clinically available CTDRs designs include a metal-on-polymer (MoP) bearing. Numerous studies suggest that MoP CTDRs are associated with issues similar to those affecting other MoP joint replacement devices, including excessive wear and wear particle-related inflammation and osteolysis [2,3]. A device with a metal-on-metal (MoM) bearing has been investigated in the current study.

Six MoM CTDRs made from high carbon cobalt-chromium (CoCr) were tested in a six-axis spine simulator, under standard ISO testing protocol (ISO-18192-1) for a duration of 4 million cycles (MC). Foetal bovine calf serum (25%v/v), used as a lubricant, was changed every 3.3×10⁵ cycles and saved for particle analysis. Components were taken down for measurements after each 10⁶ cycles; surface roughness, damage modes and gravimetric wear were assessed.

The mean wear rate of the MoM CTDRs was 0.24mm³/MC (SD=0.03), with the total volume of 0.98mm³ (SD=0.01) lost over the test duration. Throughout the test, the volumetric wear was linear; no significant bedding-in period was observed. The mean pre-test surface roughness decreased from 0.019μm (SD=0.005) to 0.012μm (SD=0.002) after 4MC of testing. Prior to testing, fine polishing marks on the bearing surfaces were observed using light microscopy. Following 4MC of testing, these polishing marks had been removed. Consistently across all components, surface discolouration and multidirectional, criss-crossing, circular wear tracks, caused by abrasive wear, were observed.

The wear results showed low wear rates exhibited by MoM CTDRs (0.24mm³/MC), when compared CTDR designs incorporating metal-on-polymer bearings (0.56mm³/MC) [4] as well as MoM lumbar CTDRs [5,6] (0.76mm3/MC – 6.2mm³/MC). These findings suggest that MoM CTDRs are more wear resistant than MoP CTDRs, however the particle characterisation and biological consequences of wear remain to be determined.

In vitro the introduction of microseparation and edge loading to hip simulator gait cycle has replicated clinically relevant wear rates and wear mechanisms in ceramic-on-ceramic bearings^[1], and elevated the wear rates of MoM surface replacements (SR) to levels similar to those observed in retrievals^[2]. The aim was to assess the wear of two different sized MoM total hip replacement bearings under steep cup inclination angles and adverse microseparation and edge loading conditions.

Two tests were performed on the Leeds II hip joint simulator using two different size bearings (28mm and 36mm). Cups were mounted to provide inclination angles of 45 degrees (n=3) and 65 degrees (n=3). The first three million cycles were under standard gait conditions. Microseparation and edge loading conditions as described by Nevelos et al^[1] were introduced to the gait cycle for the subsequent three million cycles. The lubricant was 25% new born calf serum. The mean wear rates and 95% confidence limits were determined and statistical analysis was performed using One Way ANOVA.

Under standard gait conditions, when the cup inclination angle increased from 45 degrees to 65 degrees, the wear of size 28mm bearing significantly (p=0.004) increased by 2.7-fold, however, the larger bearings did not show any increase in wear (p=0.9). The introduction of microseparation conditions resulted in a significant (p=0.0001) increase in wear rates for both bearing sizes under both cup inclination angle conditions. Under microseparation conditions, the increase in cup inclination angle had no influence on the wear rate for both bearing sizes (Figure 1).

With larger bearings, head-rim contact occurs at a steeper cup inclination angle providing an advantage over smaller bearings. The introduction of edge loading and microseparation conditions resulted in a significant increase in wear rates for both bearing sizes. The wear rates obtained in this study under combined increased cup inclination angle and microseparation were half of those obtained when SR MoM bearings were tested under similar adverse conditions^[2]. This study shows the importance of prosthesis design and accurate surgical positioning of the head and acetabular cup in MoM THRs.

Introduction

The biological response to UHMWPE particles generated by total joint replacements is one of the key causes of osteolysis, which leads to late failure of implants. Particles ranging from 0.1-1.0μm have been shown to be the most biologically active, in terms of osteolytic cytokine release from macrophages [1]. Current designs of lumbar total disc replacements (TDR) contain UHMWPE as a bearing surface and the first reports of osteolysis around TDR in vivo have appeared recently in the literature [2]. The current wear testing standard (ISO18192-1) for TDR specifies only four degrees of freedom (4DOF), i.e. axial load, flexion-extension, lateral bend and axial rotation. However, Callaghan et al. [3] described a fifth DOF, anterior-posterior (AP) shear. The aim of this study was to investigate the effect that this additional AP shear load component had on the size and morphology of the wear particles generated by ProDisc-L TDR devices over five million cycles in a spine simulator.