Abstract
Introduction
Advantages of ceramic materials for hip joint prosthesis are recognized to be high hardness, scratch resistance, improved wettability, lower friction and lower wear than CoCr surfaces. Recent studies suggest the use of ceramic femoral head reduce fretting corrosion at stem taper junction compared to metal-on-metal taper junction[1]. Continuous improvement of ceramic materials for orthopedic lead to the development of a resurfacing ceramic-on-ceramic hip joint prosthesis. The main differences of resurfacing heads respect to standard heads are their anatomical dimension and the empty shape suitable to cover the femoral bone and to connect with the resurfacing stem. Ceramic is essentially a brittle material and its strength is influenced by the minimum thickness in the stressed area. Ceramic resurfacing head minimum thickness is comparable with ceramic revision head already on the market. The aim of this study is to develop a mechanical pre-clinical analysis verification process for the newly developed system.
Materials and methods
The empty shape of the ceramic resurfacing head may influence its strength in a crush loading scenario. Although this is not a physiological condition this test represents the most severe loading for a resurfacing head. Also comparative analysis can be done considering the yield point of conventional metal resurfacing heads reported by the FDA Center for Devices and Radiological Health. For this reason a static unsupported head strength test is performed by applying a compressive load perpendicular to the head axis along the equatorial plane[2](Fig.1). Resurfacing ceramic head made in ZTA is suitable both for a resurfacing stem and an adaptor to be coupled with a standard stem. Mechanical test was performed on worst case resurfacing head size both with resurfacing stem and standard stem based and on FE non linear analysis performed in ANSYS 17.2 according the following material properties: ZTA ceramic (modulus of elasticity E, Poisson ratio ν and density ρ of 348GPa, 0.23 and 4.25g/cm3 respectively), and Ti6Al4V (E=114GPa, ν=0.33 and ρ=4.43g/cm3). For comparison purposes unsupported test was performed on standard head Ø28#S both in Biolox®Delta and Biolox®Forte ceramic. At least three components were used for each test and the average values was compared with predicates[2]. Static compressive load was applied with MTS hydraulic actuators with load cell of 100kN.
Results
FE analysis indicated the larger resurfacing head as the worst case size in the size range(Fig.2). Static unsupported head strength test was performed on resurfacing ceramic head Ø57 coupled both with resurfacing stem and standard stem, Biolox®Delta head Ø28#S, Biolox®Forte head Ø28#S and respectively reached a strength value of 53±7kN, 90±3kN, 78±27kN, 49±1kN. Equivalent test were reported in literature for DeltaSurf® Ø58 and BHRTM, and respectively reached a strength of 26kN and 5.6kN.
Discussion and Conclusion
LIMA ceramic resurfacing head and Biolox Forte Ø28#S showed equivalent unsupported head burst strength. LIMA ceramic resurfacing head showed higher unsupported head burst strength respect to DeltaSurf® and BHRTM highlighting its potential in clinical use.
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