Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Holweg, P.
A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model and in the first clinical implementation for medial malleolus fractures in adults
Doktoratsstudium der Medizinischen Wissenschaft; Humanmedizin; [ Dissertation ] Graz Medical University; 2021. pp. 68
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- Autor*innen der Med Uni Graz:
- Betreuer*innen:
- Obermayer-Pietsch Barbara
- Seibert Franz
- Sommer Nicole
- Altmetrics:
- Abstract:
- Over the last decade, there has been a high demand for the development of new, alternative materials in trauma care to overcome the disadvantages associated with conventional implant materials. Magnesium (Mg)-based alloys seem to adequately address the vision of a homogeneously resorbable, biocompatible, load-bearing and functionally supportive implant. The aim of the present study was to introduce the high-strength, lean alloy Mg‒0.45Zn‒0.45Ca, in wt.% (ZX00), and investigate for the first time the clinical applicability of screw osteosynthesis using this alloy that is free of rare-earth elements. The alloy was deployed in a growing sheep model with osteotomized bone (simulating a fracture) and compared to a non-osteotomy control group regarding degradation behavior, growth regulation and fracture healing. Finally, a prospective, non-randomized trial for the treatment of fractures of the medial malleolus using ZX00 was conducted as a first in man study. In vivo, no significant difference between the osteotomized bone and the control group was found regarding the change in screw volume over implantation time. It can thus be concluded that the fracture healing process, including its influencing factors on the surrounding milieu, has no significant influence on the degradation behavior. Additionally, there was no negative influence of hydrogen-gas formation on fracture healing. Despite the chronologically different releases of gas volumes between the proximal and distal screws, a complete consolidation of the osteotomy and no significant differences in tibiae length in terms of influencing the growth were found after 12 weeks for all animals investigated. Subsequently, the first prospective clinical investigation of fracture reduction and fixation using ZX00 presented excellent results concerning clinical and functional outcomes.