Long-term in vivo degradation behaviour and biocompatibility of the magnesium alloy ZEK100 for use as a biodegradable bone implant.
Magnesium alloys are the focus of research as resorbable materials for osteosynthesis, as they provide sufficient stability and would make surgery to remove implants unnecessary. The new degradable magnesium alloy ZEK100 was developed to improve the stability and corrosion resistance by alloying with zinc, rare earth metals and zirconium. As the implants were degraded to only a limited extent after 6 months implantation in a previous in vivo study the present study was conducted to evaluate the long-term degradation behaviour and biocompatibility in the same animal model over 9 and 12 months. Five rabbits each with intramedullary tibia implants were examined over 9 and 12 months. Three legs were left without an implant to serve as negative controls. Numerous examinations were performed in the follow-up (clinical examinations, serum analysis, and radiographic and in vivo micro-CT investigations) and after death (ex vivo micro-CT, histology, and implant analysis) to assess the in vivo degradation and biocompatibility. It could be shown that favourable in vivo degradation behaviour is not necessarily associated with good biocompatibility. Although ZEK100 provided a very high initial stability and positive biodegradation, it must be excluded from further biomedical testing as it showed pathological effects on the host tissue following complete degradation.
['Dziuba|Dina|D|', 'Meyer-Lindenberg|Andrea|A|', 'Seitz|Jan Marten|JM|', 'Waizy|Hazibullah|H|', 'Angrisani|Nina|N|', 'Reifenrath|Janin|J|']
D020341:Absorbable Implants D000497:Alloys D000818:Animals D001672:Biocompatible Materials D001842:Bone and Bones D002452:Cell Count D005260:Female D005456:Fluorescent Dyes D008274:Magnesium D008422:Materials Testing D010010:Osteoclasts D019919:Prosthesis Implantation D011817:Rabbits D013052:Spectrometry, X-Ray Emission D040521:Subcutaneous Tissue D013977:Tibia D013997:Time Factors D055114:X-Ray Microtomography
In vivo Degradation Biocompatibility Magnesium alloy Long-term study