We investigated the roles of particulate matter with unstable implant, in engendering the aggressive tissue response associated with implant loosening in humans. This study serves as a basis for establishing a controlled animal model to reproduce the conditions present after implant loosening. The model includes a 6 mm polymethylmethacrylate (PMMA) cylinder concentrically pistoning 500 m m under load in a 0.75-mm circumferential gap, inserted into canine medial femoral condyles for 8 weeks. We evaluated two size concentrations of polyethylene: type A particulate poly ethylene (0.5-12 m m), and type B particulate polyethylene (0.5-50 m m; 85% < 12 m m). The following three treatment groups were investigated in 28 unstable implants in 14 dogs: (1) without polyethylene (control), (2) with type A polyethylene, and (3) with type B polyethylene. We found an aggressive periprosthetic membrane, similar to that seen at revision in humans, only in the unstable implant with polyethylene. The features of this membrane included macrophages with intracellular polyethylene, a dense brous membrane with a synovial-like lining layer, and a sclerotic neocortex. The size distribution of the polyethylene did not alter the tissue response. An unstable implant without polyethylene resulted in a benign, quiescent membrane with loose brous connective tissue. The model creates a revision cavity analogous to that seen in revision joint arthroplasty, and merits further studies of revision joint replacement.n

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Twenty-six laboratories used X and Y chromosome probes and the same procedures to process and examine 15,600 metaphases and 49,400 interphases from Phaseolus vulgaris-leucoagglutinin (PHA)-stimulated lymphocytes. In Part I, each laboratory scored 50 metaphases and 200 interphases from a normal male and a normal female from its own practice. In Part II, each laboratory scored 50 metaphases and 200 interphases on slides prepared by a central laboratory from a normal male and a normal female and three mixtures of cells from the male and female. In Part III, each laboratory scored 50 metaphases (in samples of 5, 10, 15, and 20) and 100 interphases (in samples of 5, 10, 15, 20, and 50) on new, coded slides of the same specimens used in Part II. Metaphases from male specimens were scored as 98-99% XY with no XX cells, and 97-98% of interphases were scored as XY with 0.04% XX cells. Metaphases from female specimens were scored as 96-97% XX with 0.03% XY cells, and 94-96% of interphases were scored as XX with 0.05% XY cells. Considering the data as a model for any probe used with fluorescence in situ hybridization (FISH), a statistical approach assessing the impact of analytical sensitivity on the numbers of observations required to assay for potential mosaicisms and chimerisms is discussed. The workload associated with processing slides and scoring 50 metaphases and 200 interphases using FISH averaged 27.1 and 28.6 minutes, respectively. This study indicates that multiple laboratories can test/develop guidelines for the rapid, efficacious, and cost-effective integration of FISH into clinical service.

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