In Vivo Evaluation of Biodegradability and Biocompatibility of Fe30Mn Alloy.

OBJECTIVES:  This study aims to evaluate the biodegradability and biocompatibility of an alloy of iron and manganese (Fe30Mn) in a bone model in vivo.

METHODS:  Resorption of a Fe30Mn wire was compared with traditional permanent 316L stainless steel (SS) wire after bilateral transcondylar femoral implantation in 12 rats. Evaluation of biodegradation over 6 months was performed using radiography, post-mortem histology and microscopic implant surface analysis.

RESULTS:  Corrosion and resorption of the novel iron-manganese implant with formation of an iron oxide corrosion layer was noted on all post-mortem histological sections and macroscopic specimens (corrosion fraction of 0.84 and 0 for Fe30Mn and 316L SS, respectively). Increased bone ongrowth was observed at the wire-bone interface (bone ongrowth fraction of 0.61 and 0.34 for Fe30Mn and 316L SS, respectively). Occasionally, poorly stained newly formed bone and necrotic bone in contact with corrosion was seen. In bone marrow, Fe30Mn alloy was scored as a mild local irritant compared with 316L SS (biocompatibility score of 8.8 and 5.3, respectively). There was no evidence of systemic adverse reaction.

CLINICAL SIGNIFICANCE:  Resorbable iron-manganese alloys may offer a promising alternative to permanent metallic implants. Further in vivo studies to control implant resorption at a rate suitable for fracture healing and to confirm the biocompatibility and biosafety of the resorbable Fe30Mn metallic implant are necessary prior to use in clinical settings.