Abstract
Introduction
Metallic resurfacing systems have been widely used until pseudotumors and ALTR have been clinically found and related to excessive wear of these metal-on-metal hip systems. Hence, surgeons widely abandoned the use of resurfacing systems. Meanwhile, there is a ceramic on ceramic (CoC) resurfacing system (Embody, London, UK) made of zirconia toughened alumina (BIOLOX®delta, CeramTec, Plochingen, Germany) in a clinical safety study. Even though conventional CoC hip systems are known for their excellent wear behavior, it has to be ensured that intraoperative and in-vivo deformations of the ceramic acetabular cup do not infringe the proper functionality of the system. The method of determining the minimum clearance of such a system will be presented here.
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 uc and um are the deformations of the ceramic and the metal shell, respectively, and Km and Kc 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 uc. The resulting deformation was used as the minimum value of the clearance for the ceramic resurfacing system.
Results
The average value of the maximum deformation of the 8 generic metal shells was 177 µm (StD. 68 µm). Using the stiffness values for the ceramic and the metal shells, a maximum deformation for the ceramic shells (with the smallest and the largest outer diameter) were calculated to 56 µm and 74 µm, respectively. The superposition with the results from the FE studies led to deformation values of 69 µm (smallest shell) and 87 µm (largest shell), respectively. These values were chosen as the minimum values for the realization of the minimum clearance.
Discussion
The above described minimum clearance results from a worst-case scenario for the long-term deformation of the ceramic shells. The values from the experimental measurements were taken ten minutes after impaction in the cadaveric hips, when first relaxation already took place. Any other bone remodeling in the long-term, leading to further relaxation of the ceramic shell, has not been taken into account. The maximum deformations resulting from the numerical investigations have been superposed to the experimental values, assuming that both maximum deformations are acting in the same direction. In reality, this is most likely not the case because the line-of-action of the in-vivo forces acting on the hip are not collinear with the direction where the maximum deformation during intra-operative impaction takes place. Additionally, the experimentally chosen underreaming (1 mm) can also be considered as a worst-case. Hence, the calculated minimum clearances are representing the maximal deformation that in the long-term may take place in-vivo.
