Ion release and chromosomal damage from total hip prostheses with metal-on-metal articulation

A prospective multicentric study was carried out in patients having metal-on-metal METASUL components (Sulzer Medica, Winterthur, Switzerland) in order to check the following null hypotheses: H1: The concentration of Co, Cr, Ni, and Mb in blood and urine is not modified by the implant of a hip prosthesis with METASUL components at 6 months. H2: The incidence of markers of chromosomal damage [sister chromatid exchanges (SCEs) and micronuclei (Mni)] in lymphocytes is not modified by the implant of METASUL components at 6 months. H3: The concentrations of Co, Cr, Ni, and Mb in blood and urine did not correlate with the incidence of the markers of chromosomal damage. The measurements showed a 2-fold increase of Co in blood, a 10-fold increase of Co in urine, a 1.5-fold increase of Cr in the blood, and a 3-fold increase of Cr in the urine at a follow-up of 6 months from the operation; there was also a significant increase in the Ni blood concentration at the 7 day checkup. The study cohort did not show any modification in the frequency of markers of chromosomal damage in the peripheral lymphocytes at any of the observation times. The amount of the SCEs and Mni recorded at all the observation times did not correlate with each other or with any of the ion levels measured in the blood and in the urine.