Are dual mobility cups associated with increased metal ions in the blood? Clinical study of nickel and chromium levels with 29 months' follow-up

Abstract

Introduction: Dual mobility cups have become the implant of choice for older patients with a high risk of dislocation. However, to our knowledge, no study has explored the possibility of metal ion production with these implants that incorporate a polyethylene-on-metal bearing. This led us to conduct a prospective study to determine whether use of a dual mobility cup is accompanied by increased levels of nickel and chromium in the blood.

Hypothesis: Use of a dual mobility cup is accompanied by an increase of nickel and chromium levels in the blood.

Methods: Between 2012 and 2015, 16 consecutive patients were enrolled in the study. They underwent primary hip arthroplasty with a ceramic Biolox™ head (CeramTec, Plochingen, Germany), Corail™ titanium alloy stem (DePuy Synthes, Saint Priest, France) and a Novae™ dual mobility cup (SERF, Décines-Charpieu, France) consisting of 19% chromium (Cr) and 13-15% nickel (Ni). Patients who had other potential sources of nickel or chromium in their body (joint implants, dental implants, etc.) were excluded. The blood levels (μg/L) of nickel and chromium were measured preoperatively and at 2 years' follow-up by an independent laboratory (Biomnis) using inductively coupled plasma mass spectrometry. The upper limits set by the laboratory were<0.87μg/L for chromium and<1.0μg/L for nickel. AP and lateral X-rays of the pelvis were taken preoperatively and at each postoperative follow-up visit to look for signs of loosening. The Postel-Merle-d'Aubigné (PMA) score was determined preoperatively and at each postoperative follow-up visit. Surgical revision procedures for any cause were also documented.

Results: The mean follow-up was 29 months [13-39]. Preoperatively, blood nickel ion levels were measured in 7 patients; they were below 1μg/L in 6 patients (86%) and at 1.5μg/L in 1 patient (14%). The mean preoperative chromium ion levels (n=7) was 0.2μg/L [0-0.8μg/L]. Postoperatively, all 16 enrolled patients had their blood ion levels checked at a mean follow-up of 29 months. The nickel ion levels averaged 1.69±1.49 [0.2-5.6] (with 4/16 having>2μg/L and 12/16>1μg/L) and the chromium ion levels averaged 0.5±0.11 [0.4-0.7] (with no patients>0.7μg/L). There were no signs of loosening or osteolysis on the follow-up radiographs. The mean PMA score at 2 years was 17.8 [17,18].

Conclusion: We found that dual mobility cups generate increased nickel but not chromium ions in the blood. The levels measured are comparable to those for other orthopedic implants such as spine implants. The clinical consequences of these increased levels are not known. Nevertheless, there were no clinical or radiological signs of loosening, although the follow-up was only 2 years.

Level of evidence: IV, Cohort study.

Keywords: Chromium; Double mobility; Hip replacement; Nickel; Public health.