title: Long-term in vivo degradation behaviour and biocompatibility of the magnesium alloy ZEK100 for use as a biodegradable bone implant.
abstract: 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.
authors.affiliation: Small Animal Clinic, University of Veterinary Medicine Hannover, Buenteweg 9, 30559 Hannover, Germany.
authors.forename: Dina
authors.initials: D
authors.lastname: Dziuba
authors.forename: Andrea
authors.initials: A
authors.lastname: Meyer-Lindenberg
authors.forename: Jan Marten
authors.initials: JM
authors.lastname: Seitz
authors.forename: Hazibullah
authors.initials: H
authors.lastname: Waizy
authors.forename: Nina
authors.initials: N
authors.lastname: Angrisani
authors.forename: Janin
authors.initials: J
authors.lastname: Reifenrath
mesh_terms: D020341:Absorbable Implants; D000497:Alloys / Q000494:pharmacology*; D000818:Animals; D001672:Biocompatible Materials / Q000494:pharmacology*; D001842:Bone and Bones / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000648:ultrastructure; D002452:Cell Count; D005260:Female; D005456:Fluorescent Dyes / Q000008:administration & dosage / Q000494:pharmacology; D008274:Magnesium / Q000097:blood / Q000494:pharmacology*; D008422:Materials Testing; D010010:Osteoclasts / Q000166:cytology / Q000187:drug effects; D019919:Prosthesis Implantation; D011817:Rabbits; D013052:Spectrometry, X-Ray Emission; D040521:Subcutaneous Tissue / Q000187:drug effects; D013977:Tibia / Q000000981:diagnostic imaging / Q000187:drug effects / Q000648:ultrastructure; D013997:Time Factors; D055114:X-Ray Microtomography
chemical_list: D000497:Alloys; D001672:Biocompatible Materials; D005456:Fluorescent Dyes; C588233:ZEK100; D008274:Magnesium