Short carbon fiber reinforced composites could potentially replace some of the metal alloys used in orthopedic implants. In particular, polysulfone and, more recently, polyetheretherketone have been considered as the matrix material for carbon fiber reinforced composite implant materials. ASTM standards F813 and F619 for direct contact cell culture evaluation and extraction were employed to determine the in vitro biocompatibility of a carbon fiber composite of polyetheretherketone, PEEK, in comparison to a carbon fiber reinforced polysulfone composite. The cell cultures were assessed qualitatively by microscopy and quantitatively using an enzyme assay to determine cytotoxicity. Overall, the cellular response to the PEEK and polysulfone composites were negligible indicating that further in vivo studies with these materials are appropriate.

The use of multiple-component systems in orthopedic surgery gives the surgeon increased flexibility in choosing the optimal implant, but introduces the possibility of interfacial corrosion. Such corrosion could limit the longevity of prostheses due either to tissue reactions to corrosion products, or to device failure. The incidence and nature of corrosion of modular total hips was evaluated in a consecutive series of 79 retrieved implants from University Hospitals of Cleveland. Surfaces were examined with stereo- and scanning electron microscopy. Several laboratory studies were undertaken to examine mechanisms that might contribute to the initiation of corrosion. The first set of experiments investigated the effect of head neck extension; the second study looked at the effect of material combinations on fretting corrosion and crevice corrosion. Analysis of retrieved implants demonstrated that fretting corrosion played a major role in the initiation of interface corrosion, and that a correlation existed between corrosion and length of neck extensions. Laboratory studies showed that longer head neck extensions may be more susceptible to fretting corrosion because of an instability at the interface. Short-term mixed-metal corrosion studies demonstrated that the coupling of cobalt and titanium alloys did not render the interface more susceptible to corrosion. It is hypothesized that fretting corrosion contributes to the initiation of modular interface corrosion, and that the problem can be reduced by design changes that increase the stability of the interface.

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Although further assessment is needed, these data have suggested that IV administration of meloxicam may be a useful alternative to flunixin meglumine for postoperative treatment of horses with colic.

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Experiments were undertaken to determine whether hexavalent chromium was released during corrosion of orthopedic implants. Uptake of chromium (Cr) by cells and separation using amberlite resin were the methods used to determine that hexavalent Cr was present. We used salts of chromium as trivalent chromium (chromic chloride) and hexavalent chromium (potassium dichromate) to verify that the amberlite separation technique separates hexavalent Cr into the upper phase and trivalent Cr into the lower phase. The use of the salts also verified that only the hexavalent Cr became red blood cell-associated and that most of this was intracellular rather than membrane bound. The use of the amberlite separation technique demonstrated that the hexavalent Cr in the red blood cells was rapidly reduced to trivalent Cr. Cellular uptake of chromium was documented in red blood cells following corrosion of stainless-steel and cobalt-chromium implants in vivo, in the red blood cells of patients undergoing total joint revisions, and in fibroblasts subjected to products of fretting corrosion of stainless-steel and cobalt-chromium implants. Thus, corrosion of implants can lead to the release of the biologically active hexavalent chromium into the body. This chromium is rapidly reduced to trivalent chromium in cells.

The infection rate of implant sites bearing porous and dense implants was studied in mice. In the first model (acute infection) the mice were injected with Staphylococcus aureus subcutaneously at the implant site at the time of implantation. In the second (chronic) model the implants were left in place for four weeks for encapsulation or invasion to occur and then the organisms were inoculated. In the acute model the infection rate with the porous materials was greater. In the chronic model after tissue invasion the infection rate with the dense materials was greater. This supports the hypothesis that microorganisms can evade host defense mechanisms if they enter the pores of the implant before tissue invasion, but that once the implant is invaded with host tissue the bacteria are less apt to establish infection.

Polymer composites are being recognized as important implant materials for fracture fixation plates. The use of a composite material is dependent upon the mechanical properties of the material and its biocompatibility. The primary objective of this project was to evaluate 30% chopped-carbon-fiber-reinforced poly(etheretherketone) (CFRPEEK) as a potential material for use as a fracture fixation plate. A two-phase study was conducted. The first phase analyzed the short-term biocompatibility of CFRPEEK through rabbit muscle implant testing. CFRPEEK exhibited a nonspecific foreign body tissue reaction similar to the response observed with ultra-high-molecular-weight polyethylene (UHMWPE). In the second phase, four-hole CFRPEEK plates were implanted as internal fixation devices for transverse midshaft femoral osteotomies in beagles. The plates were effective in promoting fracture healing. A nonspecific foreign body reaction was observed to the plates and to particulate debris.