Development of a novel biodegradable porous iron-based implant for bone replacement

AbstractDespite the high potential of healthy bone to regenerate, the reconstruction of large bone defects remains a challenge. Due to the lack of mechanical stability of existing bone substitutes, recently developed degradable metallic alloys are an interesting alternative providing higher load-bearing capabilities. Degradable iron-based alloys therefore might be an attractive innovation. To test the suitability of a newly-designed iron-based alloy for such applications, an animal experiment was performed. Porous iron-based degradable implants with two different densities and a control group were tested. The implants were positioned in the proximal tibia of Merino sheep. Over a period of 6 and 12 months, blood and histological parameters were monitored for signs of inflammation and degradation. In the histological evaluation of the implants` environment we found degraded alloy particles, but no inflammatory reaction. Iron particles were also found within the popliteal lymph nodes on both sides. The serum blood levels of phosphorus, iron and ferritin in the long term groups were elevated. Other parameters did not show any changes. Iron-based degradable porous bone replacement implants showed a good biocompatibility in this experiment. For a clinical application, however, the rate of degradation would have to be significantly increased. Biocompatibility would then have to be re-evaluated.

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Local and Systemic Inflammation After Implantation of a Novel Iron Based Porous Degradable Bone Replacement Material in Sheep Model

10.21203/rs.3.rs-138400/v1 ◽

2021 ◽

Author(s):

Bernd Wegener ◽

Maik Behnke ◽

Stefan Milz ◽

Volkmar Jansson ◽

Christian Redlich ◽

...

Keyword(s):

Mechanical Stability ◽

Bone Substitutes ◽

Histological Evaluation ◽

Control Group ◽

Blood Levels ◽

Porous Iron ◽

Sheep Model ◽

Bone Replacement Material ◽

Bone Replacement ◽

Iron Based

Abstract Despite a high regenerative potential of healthy bone, replacement of large bone defects is an currently ongoing medical challenge. Due to a lack of mechanical stability of existing bone substitutes, recently developed degradable metallic alloys are an interesting alternative providing higher load bearing properties. Degradable iron-based alloys are an attractive innovation. Therefore, a degradable iron-based bone replacement material has been developed.To test the suitability of a newly designed iron-based alloy, an animal experiment was performed. Porous iron-based degradable implants with two different densities and a control group were tested. The implants were positioned in the proximal tibia. Over a period of 6 and 12 months, blood and histological parameters were monitored for signs of inflammation and degradation. Even if degradation at the desired rate was not achieved, in the histological evaluation of the implants` environment we found degraded particles, but no inflammatory reaction. Iron particles were also found within the popliteal lymph nodes on both sides. The serum blood levels of phosphorus, iron and ferritin in the long term groups were elevated. Other parameters did not show any changes.Iron-based degradable porous bone replacement implants showed a good biocompatibility in this experiment. For a clinical application, however, the rate of degradation would have to be significantly increased. Biocompatibility would then have to be re-evaluated.

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