Abstract
There has been a significant decline in the use of metal-on-metal (MoM) bearings due to concerns regarding adverse reaction to metal debris (ARMD). The Medicines and Healthcare products Regulatory Agency (MHRA) recommends annual follow-up for life with blood Cobalt (Co) and Chromium (Cr) ion level measurement in all MoM THRs with femoral head size greater than or equal to 36mm. We present the serial ten year serum Co and Cr levels in a cohort of large head MoM THRs and analyse the utility of measuring serum ions levels annually.
All patients who underwent unilateral large head MoM THR between January 2004 and December 2006 were included in this prospective study. Annual serum Co and Cr measurements were measured. Clinical case notes and radiographs were reviewed for failure, revision surgery and the occurrence of ARMD. Mann Whitney test was used to analyse changes in serum Co and Cr levels. Receiver Operating Characteristic (ROC) curve was plotted based on their sensitivity and specificity to detect ARMD.
256 patients were included. There was a significant increase in serum ion values in the first two years. After 7 years, there was no significant change in Co values(p=0.78) and there was a decline in Cr value after 9 years(p<0.001). With 7 µg/l as the cut-off value, the sensitivity and specificity of Co was 82.1% and 65.5% and of Cr was 53.5% and 91.3%.
Annual follow-up of patients with MoM THR based on the MHRA guideline to obtain serum metal ion levels can cost about £9 million/year. Our study noted poor discriminatory ability for both Co and Cr values in the ROC curve. There is poor correlation between serum metal ion levels and the occurrence of ARMD on MARS MRI. Based on our results we find limited utility in doing ion levels after 7 years in asymptomatic patients.
