ISAKOS: 2023 Congress in Boston, MA USA

2023 ISAKOS Biennial Congress ePoster

 

Toxicological Study of the Magnesium Alloys Mg-(Li)-Y and Mg-Ca-Zn-Mn for Biodegradable Bone Implants

Vojtech Havlas, Prof., MD, PhD., Prague CZECH REPUBLIC
Lucie Vistejnova, RNDr, Pilsen CZECH REPUBLIC
Filip HanĂ¡k, DM CZECH REPUBLIC
Pavel Klein, PhD, Pilsen CZECH REPUBLIC

Charles University, Prague, CZECH REPUBLIC

The FDA has not cleared the following pharmaceuticals and/or medical device for the use described in this presentation. The following pharmaceuticals and/or medical device are being discussed for an off-label use:

Summary

This study analyzed the toxicology of magnesium alloys Mg-Y, Mg-Y-Li and Mg-Ca-Zn-Mn using a rabbit model and compare them with well-known magnesium alloy Mg-Y-RE-Zr, blood tests and histology of selected organs were performed to evaluate the potential in vivo toxicity of these implants.

ePosters will be available shortly before Congress

Abstract

This study was designed to evaluate the biocompatibility and potential in vivo toxicity of the degradation products of three novel magnesium alloys Mg-3Y (W3), Mg-4Y-4Li (LW44) (extruded and ECAP forms) and Mg-0,5Ca-1,0Zn-0Mn in a rabbit model and compared them with well-known commercial magnesium alloy Mg-Y-RE-Zr (WE43). The screws and pins of these different materials were implanted into the New Zealand White rabbits' femoral shafts (2 screws and 2 pins in each animal). Blood samples were collected from ear arteries at the day of implantation (day 0) and 6, 12, 18 and 24 weeks post-surgically. Complete blood counts and biochemical parameters (liver enzymes, renal parameters, Ca, Mg, Zn and Li) were determined. The tissue samples extracted from the liver, spleen, and kidney were assessed for histological analysis after euthanization. No significant changes in blood cell count, serum levels of metal ions released from alloys, or any changes in liver enzymes and renal function parameters were detected. No systemic inflammatory reactions were observed in any of the animals. In addition, no changes in organ morphology after exposure to all types of alloys after 24 weeks of exposure were observed.