Materials and Methods

3D Finite Element studies were conducted comparing a ceramic lipped liner prototype and a ceramic conventional liner both made from BIOLOX^®delta. The bearing diameter was 36 mm. To apply loading, a test taper made of titanium alloy was bonded to a femoral head, also made from BIOLOX^®delta. Titanium was modeled with a bilinear isotropic hardening law. For the bearing contact a coefficient of friction of both 0.09 or 0.3 was assumed to model a well and poorly lubricated system. Frictionless contact was modeled between taper and liner. Pre-load was varied between 500 N and 1500 N and applied along the taper axis. While keeping pre-load constant, lever-out force was applied perpendicular to the taper axis until subluxation occurred. Liners were fixed at the taper region. Lever-out moment, equivalent plastic strain and von Mises stress of the taper, bearing contact area and contact area between taper and liner was evaluated.

Materials and Methods

2D axisymmetric Finite Element models were developed consisting of a simplified head-neck junction incorporating the surface topography of a threaded stem taper to investigate axial assembly with 1 kN. Subsequently, a base model and three modifications of the base model in terms of profile peak height and plateau width of the stem taper topography and femoral head taper angle were calculated. To account for the wear process during assembly a law based on the Archard equation was implemented. Femoral head was modeled as ceramic (linear-elastic), taper material was either modeled as titanium, stainless steel or cobalt-chromium (all elastic-plastic). Wear volume, contact area, taper subsidence, equivalent plastic strain, von Mises stress, engagement length and crevice width was analyzed.

Materials and Methods

Combined experimental and numerical results were used to determine the deformation of the ceramic shell. In a cadaver lab, the resulting deformations after impaction of generic metal shells have been measured, see e.g. [1] for the method of measurement. The maximum deformation has been chosen for further calculation. Additionally, the stiffness of both generic metal and ceramic shells has been measured using ISO 7206–12. The deformation of the ceramic shells were then calculated by the equation

where u_c and u_m are the deformations of the ceramic and the metal shell, respectively, and K_m and K_c are the respective stiffnesses. Additionally, in a finite element simulation, the resulting deformation of the ceramic shell under in-vivo conditions was calculated and superposed with u_c. The resulting deformation was used as the minimum value of the clearance for the ceramic resurfacing system.

Materials and Methods

Combined experimental and numerical studies were conducted using titanium, cobalt-chromium and stainless steel generic tapers (Figure1). Uniaxial tensile tests were performed to determine the mechanical properties of the materials examined. For the taper studies macro-geometry of ceramic ball heads (BIOLOX^®delta) and tapers were characterized using a coordinate measuring machine, and assembly experiments according to ISO7206-10 were conducted up to 4kN. Before and after loading, taper subsidence was quantified by assembly height measurements. Taper micro-geometry, taper surface deformation, and contact area were determined by profilometry. Initial numerical studies determined coefficients of friction for the three material combinations. Macro- and micro-geometries of the tapers were modelled, and taper subsidence and assembly load served as boundary conditions. Further studies used simplified models to examine effects of varying profile depths and angular gaps on surface deformation, taper subsidence, contact area, engagement length and pull-off force.

Materials and Methods

Each test series consisted of n=5 BIOLOX®delta 28–12/14 L ball heads and n=5 metal test tapers (Ti-6Al-4V, ISO 5832-3). For the reference series the metal tapers remained untouched representing the CeramTec standard test procedure. For the fluid series the ball heads were filled up with tap water or calf blood serum. For the solid series the metal test tapers were contaminated with small particles of bovine bone, commercially available bone cement and porcine fat tissue in the engagement zone. A chisel and a slight hammer tap were used to scratch the proximal region of the metal test taper. The ball heads were then manually attached to the contaminated metal test tapers without further force appliances. An apparatus according to ISO 7206-10 was used for burst testing. The tests were performed at CeramTec in-house test laboratory.

Materials and Methods

Three groups of taper-ball head couplings were investigated (n=18 titanium (Ti), n=18 cobalt chromium (CoCr), n=18 steel tapers (SS)). Line profiles of the taper surfaces were measured and tapers and ball heads were assembled using different loads (2, 4, 6 kN). Tapers were disassembled from ball heads by using liquid nitrogen, surface topography was remeasured and the effective contact area was determined. Another set of measurements was conducted (n=5 tapers per taper material) to measure the contact pressure. Here, pressure sensitive films were placed between tapers and ball heads during assembly. Using the effective contact area and contact pressure the CoF was calculated.

Materials and Methods

In order to determine the minimum clearance the following in vivo, in vitro and in silico tests were taken into account:

Eight generic metal shells were implanted into cadaveric pelvises of good quality bone realizing an underreaming of 1 mm. Maximum deformation of the metal shells (u_m) after implantation were determined using an validated optical system. The deformations were measured 10 min. after implantation.

Press-fit forces (F_pf = u_mC_m) can be calculated with the results of test 1 and 2 considering linear elastic material behaviour. Assuming force equilibrium and applying the evaluated stiffness from test 3 the deformation of the ceramic shell (u_c) occurring after implantation can be estimated (u_c = u_mC_m/C_c). For minimum clearance calculation of a monolithic ceramic shell (u_c,lt) in vivo deformation (u_c,dl) has to be considered additionally (u_c,lt = u_c + u_c,dl).

Materials and Methods

Testing was conducted with monolithic ceramic cups (under development, not approved) of size 46mm and 64mm. One cup design of each size had a constant wall thickness of 3.0mm and an offset of 0.0mm (center of rotation on front face level), the other design was lateralized with an offset of 3.5mm (46mm) or 5.0mm (64mm), leading to an increased wall thickness. First, 3 cups of each design were impacted into 1.0mm underreamed Sawbones® blocks (pcf 30, geometry: see (2)). Second, all cups were quasi-statically assembled into the Sawbones® blocks of the same design using a material testing machine. Third, the cups were placed in a two-point-loading frame (acc. to ISO/DIS 7206–12:2014(E)) and a load of up to 1kN was applied. The inner diameter of all cups was measured under unloaded and loaded conditions for all scenarios using a coordinate measurement machine at 9 locations of each cup, 1.5mm below the front face (Fig.1). As the diametrical deformation (unloaded inner diameter – loaded inner diameter) was not normally distributed a Wilcoxon test was performed to statistically analyse the deformation differences of the different cup designs (p<0.05).

METHODS

An experimental set-up imitating the in-vivo loading situation was used to analyze different scenarios that may lead to the fracture of the ball heads, such as dynamic loading, edge loading and the metal taper contamination.

58 ceramic ball heads made of pure alumina were loaded until fracture under various conditions. Parameters under investigation were the inclination of the insert, the loading velocity, and the contamination of the interface between taper and ball head.

METHODS

The stiffness of the generic shells was determined using a uniaxial/ two point loading frame by applying different loads, and the change in dimension was measured by a coordinate measurement machine (CMM). Cadaver lab deformation measurements were done before and after insertion for 32 shells with 2 wall thicknesses and 11 shell sizes using the ATOS Triple Scan III (ATOS) optical system previously validated as a suitable measurement system to perform those measurements. Multiple deformation measurements per cadaver were performed by using both hip sides and stepwise increasing the reamed acetabulum by at least 1 mm, depending on sufficient residual bone stock. The under-reaming was varied between 0mm and 1mm, respectively. From the deformations, the resulting forces on the shells and bone stiffness were calculated assuming force equilibrium as well as linear-elastic material behaviour in each point at the rim of the shell.

OBJECTIVES

Goal of this study was to investigate the risk of fretting and corrosion as well as possible loosening of large ceramic ball heads with metal sleeves.

OBJECTIVES

Since a trend exists towards the usage of larger bearings the aim of this study was to compare the tribological behavior of different ZPTA/ZPTA THAs with respect to their ball head diameter.