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MARTES / TUESDAY<br />

34<br />

• Importance of these elevations not established<br />

• ? Hypersensitivity 77<br />

• Prevalence of dermal sensitivity in patients<br />

with a total joint arthroplasty substantially<br />

higher than general population<br />

• Unclear if metal sensitivity is a contributing<br />

factor to implant failure<br />

• Currently no generally accepted test for<br />

clinical determination of metal hypersensitivity<br />

to implanted devices<br />

• No clinical data beyond 10 years for second<br />

generation metal on metal implants<br />

• Implant costs<br />

III. Ceramic on Ceramic Bearing Surfaces<br />

A. History<br />

• First ceramic on ceramic total <strong>hip</strong> performed<br />

in France in 1970 by Boutin 21<br />

• First ceramic on ceramic total <strong>hip</strong> implanted<br />

in Germany in 1974 by Mittelmeier<br />

and Walter 141,142<br />

• The Autophor implant (Richards, Memphis,<br />

TN), a Mittelmeier design, marketed<br />

in the US but abandoned secondary to<br />

unacceptable clinical results 38,123<br />

• First generation implants had limited clinical<br />

success (high fracture rate and aseptic<br />

loosening) secondary to poor materials,<br />

manufacturing, and component design;<br />

not the bearing surface itself 46,74,82<br />

• European scientists and clinicians lead<br />

development of improved materials,<br />

manufacturing, component design, and<br />

implantation technique 142,165,202,207<br />

• Simulator and retrieval studies demonstrate<br />

ceramic on ceramic bearings have the lowest<br />

wear volumes of all currently available<br />

bearing couples 50,51,61,152,157,158,164,199,207,211<br />

• New clinical studies on second and<br />

third generation bearing surfaces ongoing<br />

157,213<br />

B. Design Issues<br />

• First generation ceramic articulations:<br />

Alumina (1970)<br />

• Poor understanding of materials and<br />

manufacturing 207,213<br />

• Poor materials<br />

- Large grain size<br />

- Low density<br />

• Poor manufacturing<br />

- Large sphericity deviations<br />

- Large mismatches (diametral clearance<br />

and taper tolerance)<br />

- Large pore size<br />

• Second Generation Ceramic Articulations<br />

• Alumina (1977)- Significant advances in<br />

quality and manufacturing 37,85,182,207,215<br />

• High purity: monophase material provides<br />

long term stability<br />

• High density: provides better surface<br />

finish<br />

• Small grain size: provides increased<br />

strength<br />

• Taper lock: improved tolerance matching<br />

between mating parts<br />

• Improved processing: clean room processing,<br />

improved sintering techniques,<br />

hot isostatic pressing, laser marking and<br />

proof testing<br />

• Low porosity<br />

• Zirconia (1989)-Mixed clinical and in<br />

vitro results 36<br />

• 73% improved strength 34,54,65<br />

• Improved fracture toughness (2X) 85,182<br />

- Allows use of smaller diameter femoral<br />

heads<br />

• Strength and toughness at expense of<br />

thermal stability 17,161<br />

• 1/98 – 9/99: St Gobain Desmarquest<br />

changes manufacturing process of<br />

Zirconia femoral heads - ↑ fracture rate<br />

and FDA recall<br />

• Third Generation Ceramic Articulations<br />

• Ceramic composites (i.e. Biolox forte<br />

and delta)<br />

• Wear and thermal stability of alumina<br />

2,3<br />

• Strength and toughness of zirconia 2,3<br />

• Clinical and in vitro investigations ongoing<br />

156,186

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