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Trauma

LONG TERM STABILITY OF CERAMIC COMPOSITE IN THA

European Federation of National Associations of Orthopaedics and Traumatology (EFORT) - 12th Congress



Abstract

Introduction

In total hip arthroplasty ceramic on ceramic bearing couples are used more and more frequently and on a wordwide basis. The main reason of this choice is reduction of wear debris and osteolysis. The tribological properties and the mechanical behaviour of the implanted ceramic must remain the same throughout the patient's life.

The aim of this study was to evaluate the resistance of Alumina Matrix Composite to environmental degradation.

Material and method

The alumina matrix composite or BIOLOX ® delta is manufactured in Germany by CeramTec. It is made up of 80 vol.% Al2O3, 17 vol.% Yttria Stabilized ZrO2 and 3vol.% strontium aluminate platelets. The zirconia grains account for 1.3 mol.% of the Yttria content.

Accelerated aging tests in water steam at 142°C, 134°C, 121°C, and 105°C were performed to evaluate the aging kinetics of the composite.

X-ray diffraction was used to determine the monoclinic phase content on the material surface. Phase transformation is associated with weakness and increase in roughness of zirconia ceramic implants.

Results

The data below shows average monoclinic contents before and after aging in water vapour according to the ISO standard test (134°C, 2 bars water steam, 10 h) on the surface and inside the 28 mm taper(12/14 taper) femoral ball heads manufactured in alumina ceramic composite. There are precisions concerning the roughness and the load to failure before and after aging concerning 28mm diameter heads.

Before Aging 13%+/-3% of Monoclinic content

After 10 H at 134°C23%+/-3% of Monoclinic content the roughness of the polished surface remain the same (5nm+/− 2)

The load to failure of 28 mm heads before aging is 76 kN +/− 5kN, and 72 kN +/− 5kN after aging

The results show that although a rise in monoclinic content is predictable after long aging duration in vivo, the impact of the transformation is quite different to monolithic zirconia. A zirconia femoral head exhibits an important increase of roughness from 2 nm to more than 50 nm when submitted to the same duration of ageing.

Other tests with hip simulators under severe micro separation have been done to analyse the impact of aging on wear performance. The main wear zone on femoral heads underwent a phase transformation from tetragonal to monoclinic (23% monoclinic) at 5 milion cycles duration without any change in roughness after 5Mc duration.

Conclusion

This experimental testing program has enabled a prediction for the long-term in vivo environmental resistance of prostheses made out of Alumina Matrix Composite.

The substantial improvement in mechanical properties and the excellent wear behaviour, even under severe microseparation conditions has been clinically confirmed. Today more than 960,000 ceramic ball heads and more than 450 000 ceramic inserts made of the alumina matrix composite have been implanted. Additionally, due to enhanced mechanical behaviour, new applications in orthopaedics are possible.