Effect of Axial Load on the Flexural Properties of an Elastomeric Total Disc Replacement

Study Design. Twelve Cadisc-L devices were subjected to flexion (0°–6°) and extension (0° to -3°) motions at compressive loads between 500 N and 2000 N at a flexural rate between 0.25°/s and 3.0°/s.\ud \ud Objective. To quantify the change in flexural properties of the Cadisc-L (elastomeric device), when subjected to increasing magnitudes of axial load and at different flexural rates.\ud \ud Summary of Background Data. The design of motion preservation devices, used to replace degenerated intervertebral discs, is commonly based on a low-friction, ball-and-socket-articulating joint. Recently, elastomeric implants have been developed that attempt to provide mechanical and motion properties that resemble those of the natural disc more closely.\ud \ud Methods. Twelve Cadisc-L devices (MC-10 mm-9° and MC-10 mm-12° size) were supplied by Ranier Technology Ltd (Cambridge, United Kingdom). The devices were hydrated and tested using a Bose spinal disc-testing machine (Bose Corporation, ElectroForce Systems Group, Eden Prairie, MN) in Ringer's solution at 37°C. A static load of 500 N was applied to a device and it was then subjected to motions of 0° to 6° to 0° (flexion) and 0° to -3° to 0° (extension) at a flexural rate of 0.25°/s, 0.5°/s, 1.0°/s, 1.5°/s, 2.0°/s, and 3.0°/s. Tests were repeated at 1000 N, 1500 N, and 2000 N.\ud \ud Results. Regression analyses showed a significant ($R^2$ > 0.99, $\rho$< 0.05) linear increase in bending moment and flexural stiffness with flexion and extension angles (at 1000 N and higher loads)—a significant ($R^2$> 0.994, $\rho$< 0.05) linear decrease in flexural stiffness in flexion and extension as flexural rate increased.\ud \ud Conclusion. The bending moment of the Cadisc-L increased linearly with flexion and extension angles at 1000 N and higher loads. Flexural stiffness increased with compressive load but decreased with flexural rate.\ud \u

Effect of lubricants on friction in laboratory tests of a total disc replacement device

Some designs of total disc replacement devices have articulating bearing surfaces, and these devices are tested in vitro with a lubricant of diluted calf serum. It is believed that the lubricant found in total disc replacement devices in vivo is interstitial fluid that may have properties between that in Ringer’s solution and diluted calf serum. To investigate the effect of lubricants, a set of friction tests were performed on a generic model of a metal against metal ball-and-socket total disc replacement device. Two devices were tested: one with a ball radius of 10 mm and other with a ball radius of 16 mm; each device had a radial clearance of 0.015 mm. A spine simulator was used to measure frictional torque for each device in axial rotation, flexion–extension and lateral bending at frequencies of 0.25–2 Hz, under 1200 N axial load. Each device was tested with two different lubricants: a solution of new born calf serum diluted with deionised water and Ringer’s solution. The results showed that the frictional torque generated between the bearing surfaces was significantly higher in Ringer’s solution than in diluted calf serum. The use of Ringer’s solution as a lubricant provides a stringent test condition to detect possible problems. Diluted calf serum is more likely to provide an environment closer to that in vivo. However, the precise properties of the fluid lubricating a total disc replacement device are not known; hence, tests using diluted calf serum may not necessarily give the same results as those obtained in vivo. </jats:p

Wear of the Charité® lumbar intervertebral disc replacement investigated using an electro-mechanical spine simulator

The Charité(®) lumbar intervertebral disc replacement was subjected to wear testing in an electro-mechanical spine simulator. Sinusoidally varying compression (0.6–2 kN, frequency 2 Hz), rotation (±2°, frequency 1 Hz), flexion–extension (6° to −3°, frequency 1 Hz) and lateral bending (±2°, frequency 1 Hz) were applied out of phase to specimens immersed in diluted calf serum at 37 °C. The mass of the ultra-high-molecular weight polyethylene component of the device was measured at intervals of 0.5, 1, 2, 3, 4 and 5 million cycles; its volume was also measured by micro-computed tomography. Total mass and volume losses were 60.3 ± 4.6 mg (mean ± standard deviation) and 64.6 ± 6.0 mm(3). Corresponding wear rates were 12.0 ± 1.4 mg per million cycles and 12.8 ± 1.2 mm(3) per million cycles; the rate of loss of volume corresponds to a mass loss of 11.9 ± 1.1 mg per million cycles, that is, the two sets of measurements of wear agree closely. Wear rates also agree closely with measurements made in another laboratory using the same protocol but using a conventional mechanical spine simulator

Wear in metal-on-metal total disc arthroplasty

The wear of a model metal-on-metal ball-and-socket total disc arthroplasty was measured in a simulator. The ball had a radius of 10 mm, and there was a radial clearance between ball and socket of 0.015 mm. The model was subjected to simultaneous flexion–extension, lateral bending, axial rotation (frequency: 1 Hz) and compression (frequency: 2 Hz, maximum load: 2 kN). Throughout the tests, the models were immersed in calf serum diluted to a concentration of 15 g protein per litre, at a controlled temperature of 37 °C. Tests were performed on three models. At regular intervals (0, 0.5, 1, 2, 3, 4 and 5 million cycles), mass and surface roughness were determined; mass measurements were converted into the volume lost as a result of wear. All measurements were repeated six times. Wear occurred in two stages. In the first stage (duration about 1 million cycles), there was a linear wear rate of 2.01 ± 0.04 mm3 per million cycles; in the second stage, there was a linear wear rate of 0.76 ± 0.02 mm3 per million cycles. Surface roughness increased linearly in the first million cycles and then continued to increase linearly but more slowly. </jats:p

Properties of elastomers for small-joint replacements

Silicones are used to manufacture finger and wrist joints. However these joints have fractured prematurely in vivo. There is a lack of literature on the mechanical properties of silicones. The aim of this thesis was to investigate the viscoelastic and related properties of elastomers such as silicones and polyurethanes (suggested as a possible substitute for silicones in the implants) and to relate the properties to how an implant may perform in vivo. The viscoelastic properties of medical-grade silicones and Elast-Eon$^{TM}$3 were found to depend on frequency in compression. Above a certain frequency, the silicones appeared to undergo a transition from the rubbery to the glassy state. There is a danger that this could lead to the creation of fracture surfaces. The viscoelastic properties of the silicones were not significantly affected by the temperature; pre-treatment of specimens had no appreciable effect on the results. When the viscoelastic properties were measured in tension, there was a significant difference between the properties measured in tension and compression. Accelerated aging significantly increased the moduli of Elast-Eon$^{TM}$3, which is of some concern. The cross-link densities of the silicones were measured using a solvent swelling technique and the Flory-Rehner equation. The results showed that this method is useful as an approximate model