A750. WHAT IS AN ACCEPTABLE LEVEL OF METAL IONS AFTER METAL-ONMETAL HIP RESURFACING

Abstract

There have been many reports of metal ion levels measured in the bloodstream of patients after metal-on-metal hip replacement, and it is generally accepted that levels of cobalt (Co) and chromium (Cr) are elevated after these types of devices are implanted. However, it is not clear how to interpret these elevated levels; in particular what are the acceptable levels and what levels indicate that close monitoring of the patient is needed. Our aim was to establish the differences in metal ion levels between well functioning patients and those with clinical problems.

We measured serum Co and Cr levels (microgram’s per litre or μg/l) using inductively coupled plasma mass spectrometry with a well established collection protocol of all patients attending follow-up clinics. Our inclusion criteria for this study were all patients unilaterally implanted with a metal-on-metal hip resurfacing with no other metallic implant; patients were categorized as either A. Well Functioning or B. Clinically Problematic (pain, reduced function, reduced ROM, negative x-ray findings) and differences in ion levels between these two groups were examined. Well functioning patient data was only included if measurements were made more than 12 months post-operatively to avoid run-in wear levels. Abduction angle was also measured from x-rays of the pelvis, and the frontal plane coverage arc of each implanted cup calculated (De Haan JBJS[Br] 2008;90(10):1291–7). There were a total of 519 patients, with 358 in Group A and 161 in Group B; patients had a variety of devices with Birmingham Hip Resurfacing (64%) and Conserve Plus (29%) being the most commonly implanted. To establish a guideline upper ion level value for well functioning implants the upper 75th percentile values for Co and Cr levels for Group A patients having 15 mm or more coverage arc were calculated. The risk of having clinical problems was calculated as function of metal ion levels higher or lower than these upper limits.

The ion levels were significantly (Mann Whitney U p< 0.001) higher in Group B (mean [95% confidence intervals], Co 10.2 μg/l [5.9 to 14.5], Cr 10.3 μg/l [6.7 to 14.0]) compared to Group A (Co 2.3 μg/l [1.7 to 2.4], Cr 2.8 μg/l [2.3 to 3.4]). The well functioning upper limit for Co was 4.1 μg/l and for Cr was 5.2 μg/l. Metal ion levels greater than these upper limits were significantly (Chi-square p< 0.001) associated with the presence of clinical problems. The odds ratio for Co greater than 4.1 μg/l was 11.2 [95%CI 5.7 to 22.3] and that for Cr greater than 5.2 μg/l was 4.3 [95%CI 2.6 to 7.0].

There were significantly higher metal ion levels measured in patients with clinical problems after metal-on-metal hip resurfacing than those with well functioning hips. We have proposed upper acceptable limits for Co (4.1 μg/l) and Cr (5.2 μg/l) serum levels. Cobalt levels appear to be more reliable in predicting risk of clinical problems; levels greater than our proposed upper limit have 11 times the odds of developing clinical problems and patients with such levels should be followed closely.