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Failure rates of 2–10% provide evidence for further development in knee arthroplasty. The purpose of our study was to examine the safety of the tibial component of a novel all-ceramic total knee replacement (TKR) (BPK-S Integration ceramic) consisting of BIOLOX ® delta ceramic. The standards ISO 14879-1 and ASTM F1800-07 describe the test set-up for the experimental strength verification with a significantly increased maximum load of 5300 N (900 N are required) and post-fatigue burst strength testing. All specimens were able to prove their mechanical strength against fracture in the alternating load test. There was no material fracture in any of the included tibial components. The subsequent post-fatigue burst strength testing revealed the maximum strength against fracture of all specimens. With at least 9.7 kN for size 3 and at least 12.1 kN for size 6, all specimens showed relatively large strength reserves to the stress in the alternating load test. So far we simulated an  in vivo  lifetime of 10 years for the tibial component. Further studies should be conducted in which longer  in vivo  lifetimes of the components are simulated to investigate possible fatigue of the used material over a longer period of time.

A novel ceramic tibial component is as safe as its metal counterpart