It is believed that wear of replacement joints A five active degree of freedom (DOF) spine simulator was used to compare the effects of varying the kinematic and loading input parameters on a ProDisc-L TDR (Synthes Spine). A four DOF standard ISO (ISO18192-1) test was followed by a five DOF test which included the AP shear force. The standard ISO test was repeated on a second simulator (of identical design) but with the phasing of the lateral bend (LB) and flexion extension (FE) motions changed to be in-phase, creating a low cross-shear motion pattern. The standard ISO test was then modified to give half the ISO standard axial loading. All tests conducted were based on the ISO18192-1 standard for lumbar implants with 15 g/l protein lubricant and modified as described. Gravimetric wear measurements were taken every million cycles (mc) in units of milligrams (mg). Six discs were tested to give statistically significant results.Introduction
Methods
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. A six-station lumbar spine simulator (Simulation Solutions, UK) was used to test ProDisc-L TDR components (Synthes Spine, USA) under the ISO 18192-1 standard inputs and with the addition of an AP load of +175 and −140N. Wear particles were isolated at 2 and 5 mc using a modified alkaline digestion protocol [4]. Particles were collected by filtration and imaged by high resolution FEGSEM. Particle number and volume distributions were calculated as described previously [4] and were compared statistically by one way ANOVA (p<0.05).Introduction
Methods
Total disc replacement is an alternative to spinal fusion in treating degenerative disc disease, whilst preserving motion and reducing the risk of subsequent DDD at adjacent levels. Current designs have evolved from technology used in total hip replacements with metal-metal or metal-PE bearing surfaces. These articulating systems may be prone to wear and it is essential the medical engineering community assess their performance using appropriate simulators Utilising previous Leeds simulation design experience, current knowledge on spinal kinetics and prevailing Standards for spinal testing, a comprehensive set of requirements was generated from which a simulator design was produced. The Leeds Spine wear simulator, developed in conjunction with Simulation Solutions Ltd, incorporates five active degrees of freedom: axial compression, axial rotation, flexion-extension, lateral bending and anterior-posterior displacement. The fifth DOF, unique to the Leeds simulator, is anticipated to be particularly important for the study of mobile bearing devices such as the Charité. Loads and motions are applied by electro-mechanical actuators, providing accurate and precise control without the low band width suffered from pneumatics or contamination from hydraulic systems. This validation study determines the accuracy and precision of the simulator with regards to the degrees of freedom required by the newly published standard ISO 18192-1. Here, loads and motions have to be within ±5% of the maximum value and ±0.5degrees, respectively. The simulator’s response to demand input signals was determined for load and motion using independent measuring devices; a digital inclinometer for motions and load cell for force. The load calibration was found to be within ±1% of the maximum load within the specified load range of 600–2000N. Flexion-extension, lateral bending and axial rotation were found to be within ±0.5, ±0.3 and ±0.5 degrees respectively, within and beyond the operating ranges specified by ISO. The Leeds spine wear simulator is the first orthopaedic wear simulator to include electro-mechanical actuators for all active DOF, and the first spinal wear simulator to include a minimum of 5 active DOF. This novel simulator meets the demanding tolerances required by ISO for testing of total disc replacements. Validation of the simulator is currently being undertaken to determine its suitability against explanted devices and debris located within tissues.
