Biocompatibility testing of simulated total joint arthoplasty articulation debris.

Surface characterization was performed to evaluate the surface condition of an uncoated cobalt alloy disc (control), and discs with medium and thick boron coatings for total joint articulating surfaces. Discs were characterized by scanning electron microscopy before and after dissolution studies. Chemical analyses of elemental transfer to the solution were assessed to evaluate the surface stability of the new coating. An in vivo biocompatibility study for particulates [of boron (B), titanium alloy (Ti), cobalt alloy (Co), and combinations of B + Ti and B + Co] was performed using a rat air pouch model. The inflammatory reactions to particulates were evaluated histologically and histochemically. No physical alteration was seen in the discs after the dissolution studies, and the elemental transfer to the dissolution solution was minimal. The cytokines, tumor necrosis factor (TNFalpha), and histology results from these simulated debris showed similar and moderate level responses magnitudes for the boron and mixtures and the primary alloy particulates. The conclusion from this initial study was that assessments of the coated discs showed physical properties similar to control. Also results from the in vivo studies of simulated wear debris from boron coatings on titanium and cobalt alloys demonstrated biocompatibility profiles that were mild to moderate and similar to prior analyses of wear debris products in synovial pouch models.