Metal Ion Release: Also a Concern for Ceramic-on-Ceramic Couplings?

Abstract

BIOLOX delta is the newest ceramic composite material of the BIOLOX family and its use in hip devices represents a good alternative to Metal-on-Metal or Metal-on-Polyethylene coupling. Some Metal-on-Metal hip devices have shown chromium and cobalt release, which promoted toxic effects. Furthermore, the ceramic composite contains trivalent chromium, even if strongly bound to the alumina lattice. The present study is aimed at detecting any 'in vivo' release of chromium ions from BIOLOX delta bearings in the blood, erythrocytes and urine of patients. Twenty patients implanted with total hip arthroplasty (THA) with BIOLOX delta-BIOLOX delta couplings and 21 subjects with no implanted prostheses were studied. Inductively coupled plasma mass spectrometry equipped with dynamic reaction cell was used for analysis. In the THA group the Cr ions values were; in blood mean 0.21 µg/l (±0.09), in serum 0.21 µg/l (±0.12), in normalized erythrocytes 0.13 µg/l (±0.09), in normalized urine 0.12 µg/g creatinine (±0.13). In the control group the Cr ions values were; in blood mean 0.22 µg/l (st dev 0.14), in serum 0.17 µg/l (±0.08), in normalized erythrocytes 0.13 µg/l (±0.11), in normalized urine 0.07 µg/g creatinine (±0.08). The Lab reference values were 0.1-5.0 µg/l for blood, 0.1-0.5 µg/l for serum, 0.14-4.58 µg/l for normalised erythrocytes and 0.05-2.2 µg/l for urine. All samples in both groups resulted in chromium levels within the normal reference range and the safety of BIOLOX delta ceramics, in terms of chromium ions release, has been demonstrated.

Cementless Total HIP Arthroplasty Using Biolox®Delta Ceramic-on-Ceramic Bearing in Patients with Osteonecrosis of the Femoral Head

“…Enhanced mechanical properties increase the durability of the ceramic and allow greater design freedom. In particular, the use of large diameter femoral head components should reduce the risk of dislocation without changing neck diameter, improve stem mobility, and reduce the risk of impingement between the rim of the liner or cup and the neck of the stem (12).…”

“…In addition, large diameter ceramic heads might have higher wear rates. Hajjar et al (12) assessed the effect of increasing head size on the wear of Biolox®delta CoC bearings. Under microseparation using edge loading conditions, the wear rate of 36 mm bearings (0.22 mm 3 /million cycles) was greater than that of 28 mm bearings (0.13 mm 3 /million cycles), but the wear rate of Biolox Delta COC bearings under microseparation conditions was still very low (<0.25 mm 3 /million cycles) compared to earlier generation COC bearings (Biolox®forte, 1.84 mm 3 /million cycles) and other bearing materials such as MoM bearings (2-8 mm 3 /million cycles).…”

“…The so-called fourth generation ceramics, Biolox®delta (CeramTec, Plochingen, Germany), in which zirconia is incorporated into the alumina matrix, was developed to reduce the rates of head component and liner fractures. Reportedly, the incorporation of zirconia into the alumina ceramic matrix prevents the development of cracks, and thus, theoretically, the improved mechanical properties of the alumina composite provide more design freedom, and thus, allow the use of large diameter femoral head components to reduce dislocation rates (11–12–13). Although the mechanical properties of this ceramic are better than those of earlier generation ceramics, existing data on this material is limited.…”

In vivo response of heme-oxygenase-1 to metal ions released from metal-on-metal hip prostheses

“…Conversely, as far as the lack of effect of circulating Cr on HMOX-1 induction is concerned, this is probably due to the fact that only Cr (III) was circulating and does not appear to exert any direct effect on HMOX-1 (43). Previous studies (47,48), have demonstrated that the Cr released by MoM prostheses and present in circulation is in the Cr (III) form. This was confirmed by preliminary evaluations of a small group of samples, in which the chemical speciation was determined by hyphenated techniques (HPLC-ICP-MS), investigating the concentration of Cr (III) and Cr (VI) in the synovial fluid of patients with prostheses, confirming that the only species present is Cr (III) (unpublished data from Laboratory of Toxicology and Industrial Hygiene, University of Brescia, Italy).…”

Large head ceramic-on-ceramic bearing in primary total hip arthroplasty: average 3-year follow-up of a multicentre study

“…However, cobalt is missing from large-head CoC bearings and studies have shown lower fretting and corrosion scores, 5 low titanium ion levels and low Chromium levels with ceramic heads used with or without a titanium alloy sleeve. 21,22 In conclusion, new technology should be introduced on the market cautiously. This is especially true for the preassembled large diameter ceramic monoblock acetabular component used in this study since it resembled the acetabular component used with large-head MoM THA.…”