Abstract
Introduction
Metal-on-metal bearings (MoM) have been reported to release metal ions that are potentially leading to adverse tissue reactions. Alternatively, ceramic-on-ceramic bearings (CoC) are an attractive treatment for young and active patients and composite materials like zirconia toughened alumina (ZTA) have been successfully introduced clinically. One of the most common ZTA-material in CoC is the Biolox® delta, manufactured by Ceramtec. Along with alumina and zirconia, this material also contains traces of chromium, strontium and yttrium. The aim of this study was to analyse the ion release for these materials clinically as well as experimentally.
Material and Methods
Within a clinical trial, three different patient groups were compared: a) a control group without any implants, b) patients, three months after unilateral treatment with Biolox® delta CoC and c) patients, twelve months after unilateral treatment with Biolox® delta CoC. Whole-blood samples were collected and analysed in regards to the trace elements using high-resolution-ICP-MS. In the experimental setup, the leaching behaviour of five Biolox® delta ceramic heads and five CoCr-heads was analysed. The heads were immersed in serum for seven days at 37°C. The ion-release of aluminium, zirconium, cobalt, chromium, strontium and yttrium were detected based on high-resolution-ICP-MS.
Results
In the patient groups, most elements remained below their specific limit of detection (LoD), except for aluminium and strontium. For aluminium, the values of the control and the twelve- month group were below the LoD (27.2µg/L) and the three month values were only slightly increased (median: 34.2µg/L). For strontium median values of 39.7µg/L were found in the control group which were higher after three month (79.6µg/L) and returned to 41.1 µg/L after twelve months. However, this difference was not statistically significant. The leaching experiments showed that high amounts of cobalt (177.3µg/L) and chromium (4.2µg/L) were released from the metallic heads, which was not seen in the ceramic material. Similar to the patient control group, a seemingly high background-concentration of strontium was found in the serum (98.3µg/L) which was only slightly increased by the ceramic material (107.7µg/L).
Discussion and Conclusion
The current study revealed that there was no significant increase of any analysed material or trace elements in the target patients treated with CoC bearings. The clinical trial also showed that strontium is a trace element that exists in the human body regardless of the presence or absence of an implant. However, with MoM high values of cobalt were released. As this release occurred even without any joint articulation, as shown in the experiments, surface corrosion seems to be a relevant mechanism in the ion release of MoM. A limitation of the study is that different patient groups were compared within the clinical trial.
