Biomechanical testing showed higher pull-out forces for magnesium compared with a commercial polymer screw. Hence, they suggest better stability and are a potential alternative. The thread geometry does not significantly influence the stability provided by the magnesium implants. This study shows the first promising results of a degradable material, which may be a clinical alternative in the future.
In this in vitro study, magnesium plates of ZEK100 and MgCa0.8 alloy similar to common titanium alloy osteosynthesis plates were investigated as degradable biomedical materials with a focus on primary stability. Immersion tests were performed in Hank's Balanced Salt Solution at 37 C. The bending strength of the samples was determined using the fourpoint bending test according to ISO 9585:1990. The initial strength of the noncorroded ZEK100 plate was 11% greater than that of the MgCa0.8 plate; both were approximately 65% weaker than a titanium plate. The bending strength was determined after 48 and 96 h of immersion in Hank's Balanced Salt Solution; both magnesium alloys decreased by approximately 7% after immersion for 96 h. The degradation rate and the Mg 2þ release of ZEK100 were lower than those of MgCa0.8. Strong pitting and filiform corrosion were observed in the MgCa0.8 samples after 96 h of immersion. The surface of the ZEK100 plates exhibited only small areas of filiform corrosion. The results of this in vitro study indicate that the ZEK100 alloy may be more suitable for biomedical applications.
Degradable magnesium alloys are promising biomaterials for orthopedic applications. The aim of this study was to evaluate the potential effects on both the synovial membrane (synovialis) and the synovial fluid (synovia) of the degradation products of a MgYREZr-pin implanted in the intercondylar femoral notch in a rabbit model. Thirty-six animals were randomized into two groups (MgYREZr or Ti6Al4V alloy) of 18 animals each. Each group was then divided into three subgroups with implantation periods of 1, 4, and 12 weeks, with six animals in each subgroup. The initial inflammatory reaction caused by the surgical trauma declined after 12 weeks of implantation, and elucidated a progressive recovery of the synovial membrane. Compared with control Ti6Al4V pins, there were no significant differences between the groups. However, after 12 weeks, recovery of the synovial membrane was more advanced in the titanium group, in which 92% showed no signs of synovitis, than in the magnesium group. A cytotoxicity test with L929 cells and human osteoblasts (HOB) was also conducted, according to EN ISO 10993-5/12, and no toxic leachable products were observed after 24 h of incubation. In conclusion, the MgYREZr alloy seems to be a suitable material for intra-articular degradable implants.
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