In a randomized study of 60 patients allergic reactions are evaluated in three joint prosthesis groups, a resurfacing arthroplasty (ReCap), a non-cemented, large metal-on-metal head (Bimetric Magnum) and a non-cemented, alumina ceramic-on-ceramic bearing in a titanium shell (Bimetric C2a). The inclusion criteria were osteoarthritis, ASA I–II, MRI-scan without caput necrosis, DXA-scan without osteoporosis. The exclusion criteria were short neck (<2cm.), large cysts (>1cm.), medical treatment affecting the bone metabolism, severe deformity of the femoral head, impaired kidney function and inability to co-operate. Blood samples were drawn prior to and 6 weeks, 6 months, 1 year, and 3 years after surgery; two tubes from which plasma was prepared, and two tubes for serum. From the last included 20 patients in each group was also taken blood one and three years after surgery for an in vitro lymphocyte assay for scoring of possible hypersensitivity to prosthesis metals. The isolated lymphocytes were subjected to measurement of proliferation and expression of CD69 by flow cytometry and measurement of the Migration Inhibitory Factor (MIF) by ELISA. Plasma concentrations of the cytokines IL-1, IL-4, IL-6, IL-8, IL-12p70, IL-15, interferon-and osteoprotegerin were determined by multiplex-immunoassay. Serum concentrations of chromium and cobalt were determined by graphite furnace atomic absorption spectrometry. The serum concentrations of chromium and cobalt were lowest in patients with the C2a implant and highest with Magnum, some of these differences were significant at 6 weeks, 6 months, and 1 year after surgery. No patient had a very high serum metal concentration. The values of the variables measured in the in vitro lymphocyte assay mainly changed in the expected direction depending on the concentration of the same metal in the serum sample drawn at the same time, but no significant correlation was seen. One patient had uncertain symptoms of metal hypersensitivity and relatively high serum metal concentrations 3 years after arthroplasty with a Magnum prosthesis and was assessed extraordinarily, and elicited the marginally highest MIF responses in the lymphocyte assay. A strong correlation was found between the plasma concentrations of most cytokines, but the cytokine concentrations were not correlated to contemporary metal concentrations.
INTRODUCTION. The advantages of large diameter metal on metal total hip arthroplasty (MoM THA) and hip resurfacing arthroplasty are decreased wear rate, preservation of bone stock, anatomical restoration and enhanced stability. Large amounts of metal wear particles and metal ions are released which may induce adverse reactions including local soft tissue toxicity, hypersensitivity reactions, bone loss and risk of carcinogenesis. Aseptic loosening can be the result of a peri-prosthetic osteolysis generated as a result of a biological response to particulate wear debris. No reports in the literature exist as to whether circulating levels of Chromium (Cr) and Cobalt (Co) decrease upon removal of a symptomatic large diameter MoM implant or whether levels remain high due to the effect of metal ions debris left behind in the soft tissues after revision surgery. PATIENTS AND METHODS. Between June 2006 and June 2009 we undertook 44 revision surgeries of both large head MoM THAs (femoral head diameter 38mm) and metal-on-metal hip resurfacings for suspected metallosis. Mean time from original implant to revision was 4 years, 8 months (1yr 4mo–7yr 9mo). The mean follow up evaluation was 2 years and 2 months (1yr 2mo–4 years). Blood samples were taken for whole blood Cr and serum Co according to a recognised protocol and compared with reference levels indicated by the Medicines and Healthcare Regulatory Agency recommendation of less than 7ppb for Cr (130nM/L) and Co (119nM/L). RESULTS. 42 patients were found to have histological evidence of either
