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Bioceramics and how they became accepted for artificial hip joint use

The Medical Products Division of CeramTec is the global leader in the manufacture of bioceramic hip joint replacements. It supplies ceramic components to the majority of orthopaedic companies worldwide (see Modular Implants. For more than 30 years CeramTec has set the standard for quality and reliability due to its innovative materials technology.

The start of the success story

In 1970/1971 Professor Pierre Boutin used for the first time cemented and cementless hip prostheses with wear couples made of aluminium oxide ceramic. That was the start of the success story for ceramics in hip replacement. The reason for his focus on ceramic materials was the onset of failures encountered with “classical” hip replacement wear couples. The original metal - metal bearings required revision, because of early cup loosening. These were displaced by metal - polyethylene components. However, it soon became clear that the high wear rate of metal - polyethylene joints, led to the loosening and revision of these joints also. The term “aseptic loosening” was coined as a result. The solution to the problem of “polyethylene wear disease” became a matter of interest and is still an important topic today. Professor Pierre Boutin’s selection of the aluminium oxide material as a means of resolving the wear related issues of the time was based on his knowledge of the excellent wear resistance and biocompatibility of the material and from the fact that this material had already been used with success in space technology.

First use of BIOLOX^® wear couples

In Germany Professors H. Mittelmeier (Homburg/Saar) and P. Griss (Marburg) did significant pioneering work. On 24 October 1974 Professor H. Mittelmeier in the Homburg/Saar hospital did the first successful implantation of a BIOLOX^® ceramic wear couple. This was possible on account of the close collaboration with the medical department of the former Feldmühle AG (now CeramTec) in Plochingen, Germany. Until this time hip replacement had been restricted to predominantly older patients on account of wear problems, but now the use of wear resistant, high quality BIOLOX^® ceramic offered the possibility of hip replacement in younger and more active patients also. With the widening of the clinical indications to include a younger, more active patient population came requirements for better hip joint performance and increased implant lifetime.

BIOLOX^®forte

In 1994 BIOLOX^®forte was placed on the market for the first time. The term "forte" was chosen to indicate the higher mechanical properties and improved component safety, which were achieved as a result of an optimisation of the manufacturing processes. The key elements of this optimisation were: improved powder preparation, improved sintering technology including the use of hot isostatic pressing, improved product identification using laser marking and the final testing of each component by means of a so-called proof test. In the USA BIOLOX^®forte was placed on the market in 1995, but ceramic - ceramic wear couples were not approved for sale until the spring of 2003. This was the moment when the official approval was granted by the American Food and Drug Administration (FDA), which is the agency responsible for the regulation of medical devices in the USA. This approval is a further confirmation of the successful clinical use of BIOLOX^® implants, since it required the successful completion of multiple multi-centre FDA-type clinical studies each with extensive patient follow-up.

BIOLOX^®delta

A further milestone in joint replacement technology was the recent introduction of BIOLOX^®delta the biocompatible, high performance alumina matrix composite. This ceramic material with its superior mechanical properties offered the product designers the possibility of meeting higher performance applications in orthopaedics. Such applications were not previously realisable using ceramics and include for example complicated product geometries and thin-walled components.

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