Abstract
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.
