Abstract
ARMD (Adverse Reaction to Metal Debris) is an increasingly recognised complication of metal on metal hip replacements. The MHRA (Medical and Healthcare Related Devices Agency) have advised a blood cobalt or chromium level above 7 mg/L is a threshold for further investigation, stating that “low levels are reassuring and strongly predict not having an adverse outcome”. Cross-sectional imaging should be performed when levels are above 7 mg/L. We have performed a study investigating the specificity and sensitivity of chromium and cobalt metal ion levels as a screening measure for ARMD.
79 ASR hip replacements were performed at our hospital and 75 (95%) of these underwent a Metal Artefact Reduction Sequence (MARS) MRI scan. All patients (64 hips) who had not undergone revision were invited to take part in this study. 57 patients with 62 hip replacements completed hip and activity scores, had blood cobalt and chromium ion level measurements and 3D-CT to measure acetabular component position.
Acetabular component inclination (>50 degrees), small head size (< 51mm) and female gender were significantly correlated with raised chromium (Cr) and cobalt (Co) ion levels. An ARMD was detected using MRI in 18 (29%) of the hips in this study. The incidence of ARMD was significantly higher when chromium concentration was above 7 mg/l (p = 0.02). Chromium ion levels >7 mg/L had a sensitivity of 56% and specificity of 83% for ARMD, and cobalt ion levels >7 mg/L 56% and 76% respectively. 40 patients had cobalt levels <7 mg/L and 33 had chromium levels <7 mg/L, but 8 of these had an ARMD on MRI. All 8 patients had minimal symptoms (Oxford Hip Score ≥ 44 out of 48).
The Medicines and Healthcare Products Regulatory Agency (MHRA) has recommended that cobalt and chromium levels be measured in patients with a metal-on-metal hip replacement and cross-sectional imaging performed when these levels are above 7 μg/L. This study has shown that by using this threshold, in patients with this implant combination, the sensitivity and specificity for the detection of ARMD is low and patients with soft tissue disease may be missed. Furthermore the presence of MRI detected ARMD, in the absence of significant clinical symptoms and with metal ion levels <7 μg/L is of concern.
MoM implants at risk of failure are associated with raised cobalt and chromium levels. However metal ion analysis alone is not reliable as a screening tool for ARMD, which is often clinically “silent”. We recommend the routine use of MARS MRI as the safest method of ARMD diagnosis in patients with MoM implants.
