Wear simulation of a polyethylene-on-metal cervical total disc replacement under different concentrations of bovine serum lubricant.

Metal-on-polyethylene total disc replacements have been an alternative to spinal fusion in the lumbar spine under certain indications for more than a decade. Recently, cervical total disc replacement has also become an alternative to cervical fusion. Knowledge acquired from years of in vitro simulator studies on other joint replacements has highlighted the risks associated with premature wear due to unforeseen adverse clinical conditions and the effect of particulate debris on surrounding natural tissues. Having no evidence of the type and composition of the lubricating fluid that will result after spinal arthroplasty, a study on the effects of lubricant serum concentration was undertaken. The wear rate was shown to be inversely proportional to protein content of the serum over a range of 50%-3% bovine serum to water concentration.

Wear and biological effects of a semi-constrained total disc replacement subject to modified ISO standard test conditions.

Development of pre-clinical testing methodologies is an important goal for improving prediction of artificial replacement joint performance and for guiding future device design. Total disc replacement wear and the potential for osteolysis is a growing concern, therefore a parametric study on the effects on wear of altered kinematics and loading was undertaken. A standard ISO testing protocol was modified in order to study the wear behaviour of lumbar total disc replacements when subject to low cross shear input kinematics, reduced axial loading and smaller flexion-extension magnitude. Volumetric wear, bearing surface topography, and wear debris biological reactivity were assessed. The ISO standard results were expected, however, the very low cross shear test produced a level of wear approximately two orders of magnitude higher than that reported for zero cross shear motions on UHMWPE bearings. When the osteolytic potential of the wear particles was calculated, all total disc replacement simulations had lower predicted osteolytic potential compared to total hip replacements, as a consequence of the generally lower wear rates found.

The effect of anterior-posterior shear load on the wear of ProDisc-L TDR.

The current wear-testing standard (ISO18192-1) for total disc replacement (TDR) requires only four degrees of freedom (DOF) inputs: axial load, flexion-extension, lateral bending and axial rotation. The study aim was to assess the effect of an additional DOF, anterior-posterior (AP) shear on the wear of the ProDisc-L TDR. A 5DOF simulator was used to test ProDisc-L implants under 4DOF and 5DOF conditions. The 4DOF conditions were defined by ISO18192-1 whilst the 5DOF used ISO18192-1 conditions with the addition of an AP load of +175 and -140 N (anterior and posterior, respectively), extrapolated from in vivo data. The implants were mounted such that the polyethylene insert could be removed for gravimetric measurements. Tests were run using bovine serum (15 g/l protein concentration) as a lubricant for five million cycles (MC), with measurements repeated every 1 MC. The mean wear rate in the 4DOF test was 12.7 +/- 2.1 mg/MC compared to 11.6 +/- 1.2 mg/MC in the 5DOF test. There were marked differences in the wear scars between 4DOF and 5DOF simulations. With 4DOF, wear scars were centralised on the dome of the insert, whilst 5DOF scars were larger, breaching the anterior rim of the dome causing deformation at the edge. The 4DOF wear test showed similar gravimetric wear rates to previously published ISO-tested TDRs. The addition of AP load was found to have no significant effect on the overall wear rate. However, there were pronounced differences in the respective wear scars, which highlights the need for more research in order to understand the factors that influence wear of TDR.