Abstract
Introduction
The utilization of ceramic components in Total Hip Arthroplasty has experienced an expanded acceptance by the orthopedic community. This increased acceptance has been largely due to the lower risk of fracture due to the introduction of zirconia toughened alumina ceramics. This extra-high strength ceramic composite has been proven clinically over the past 13 years and found to be much more reliable than previous ceramic materials. The goal is to verify this finding by published registry data as well as clinical outcome.
Methods
Registry data on fractured ceramic components have been compared with the data received from the largest manufacturer of ceramic hip components. Additionally, the clinical outcome of ceramic on ceramic artificial hips has been evaluated.
Results
The fracture rate of ceramic BIOLOX®delta ball heads is reported to be 0.001% by the manufacturer. The comparison with published registry data exhibits fracture rates of the same order of magnitude: 0.002% (1/ 52,741) by the Australian Registry (2014), 0.001% (3/230,769) by the French Health Authorities (2014), and 0.005% (1/18,090) by the Italian Emilia Romagna Registry (2014). The fracture rate of ceramic BIOLOX®delta inserts is reported to be 0.021% by the manufacturer. The comparison with published registry data again exhibits fracture rates in the same order of magnitude: 0.06% (17/27,752 implanted inserts) by the Australian Registry (2014), 0.025% (28/112,000) by French Health Authorities (2014), and 0.06% (10/14,493) by the Italian Emilia Romagna Registry (2014).
Discussion
The comparison between the fracture data released by the world's largest manufacturer of ceramic hip components and the published registry data are in same order of magnitude. The fracture rate of BIOLOX®delta ball heads is very low and can be considered as negligible compared to the rate of revision due to other reasons. The comparison between the reported fracture rate of ceramic inserts of the manufacturer and registry data also yields similar results. Looking at the reasons for fracture, 82% of the liner fractures reported to the manufacturer can be most likely assigned to handling related reasons (malaligned positioning or insufficient fixation).
The results clearly confirm the excellent reliability of this 4th generation ceramic even when used in the younger and more active patients. A proper handling according to the IFU is necessary to ensure its superior clinical behaviour.
