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.

Bioresorbable Fe-Mn and Fe-Mn-HA Materials for Orthopedic Implantation: Enhancing Degradation through Porosity Control.

Resorbable, porous iron-manganese-hydroxyapatite biocomposites with suitable degradation rates for orthopedic applications are prepared using salt-leaching for the first time. These transient biomaterials have the potential to replace inert, permanent implants that can suffer from long-term complications, or have to be surgically removed, leaving an unfavorable void. Fe30Mn-10HA materials are newly developed to address inadequate resorption rates of degradable materials proposed for orthopedic environments in the past. In this study, controllable porosities with 300 µm diameter pores are introduced into Fe30Mn alloys and Fe30Mn-10HA composites, which enhance tissue ingrowth. For the composites, a Ca2 Mn7 O14 phase generated within the Fe30Mn matrix during the sintering process greatly increases degradability. The combination of this second phase and added porosity is found to contribute to increased bone-like apatite layer formation, mouse bone marrow mesenchymal stem cell attachment, and reduction of detrimental oxide layer flaking. Remarkably, after thirty days in vitro, there is a significant increase in degradation up to 0.82 ± 0.04 mm per year for 30 wt% porous Fe30Mn-10HA biocomposites, compared to 0.02 ± 0.00 mm per year for traditional nonporous Fe30Mn, thereby increasing the viability of these materials for future clinical studies.

Nanoporous metals for biodegradable implants: Initial bone mesenchymal stem cell adhesion and degradation behavior.

Nanostructured Fe-Mn and Fe-Mn-Zn metal scaffolds were generated through a well-controlled selective leaching process in order to fulfill the growing demand for adjustable degradation rates and improved cellular response of resorbable materials. Mouse bone marrow mesenchymal stem cells (D1 ORL UVA) were seeded onto eleven, carefully chosen nanoporous surfaces for 24 h in vitro. Using a combination of fluorescence microscopy, scanning electron microscopy (SEM), and an MTS assay, it was discovered that scaffolds with nanoscale roughened surfaces had increased cell attachment by up to 123% compared to polished smooth Fe-Mn surfaces. Significant cell spreading and construction of cell multilayers were also apparent after 24 h, suggesting better adhesion. Additionally, static electrochemical polarization experiments revealed an improvement of up to 26% in the actual rate of biodegradation for Fe-Mn surface-modified materials. However, any residual concentration of zinc after leaching was shown to slightly increase corrosion resistance. The results demonstrate that selectively leached, nanostructured Fe-Mn surfaces have the potential of being tailored to a diverse set of transient implant scenarios, while also effectively boosting overall biocompatibility, initial cell attachment, and degradation rate. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 1747-1758, 2016.

Evolution of novel bioresorbable iron-manganese implant surfaces and their degradation behaviors in vitro.

The purpose of this study is to advance understanding of surface degradation kinetics for Fe-Mn bioresorbable alloys (specifically Fe-20%Mn) and target degradable fracture fixation implants for hard tissues. This study addresses how arc melted Fe-20%Mn discs degrade in a static, osteogenic medium for up to a 3 month time span. Degradation behavior of these bulk alloys was investigated using both mass loss tests for measuring long-term corrosion rates and potentiostatic tests for following the instantaneous rate of degradation. It was discovered that cold-rolling Fe-20%Mn to 77% cold work (CW) suppressed the instantaneous corrosion rate compared with the cast structure. It was also found that an unstable iron-rich oxide layer forms on the entire surface of these bulk samples and the act of machining the bulk metal into a defined shape may affect the morphology of the oxide layer on the outer edge of the samples during degradation. The mechanisms behind the surface evolution of these potential orthopedic implants are investigated in detail.

Effect of microstructure and strain on the degradation behavior of novel bioresorbable iron-manganese alloy implants.

Advancing the understanding of microstructural effects and deformation on the degradability of Fe-Mn bioresorbable alloys (specifically, Fe-33%Mn) will help address the current problems associated with designing degradable fracture fixation implants for hard tissues. Potentiostatic polarization tests were conducted on a wide variety of metal samples to examine how different deformation processes affect the instantaneous rate of degradation of Fe-Mn alloys. Large-strain machining (LSM), a novel severe plastic deformation (SPD) technique was utilized during these experiments to modify the degradation properties of the proposed Fe-Mn alloy. It was discovered that Fe-33%Mn after LSM with a rake angle of 0° (effective strain = 2.85) showed the most promising increase in degradation rate compared to as-cast, annealed, and additional deformation conditions (rolled and other LSM parameters) for the same alloy. The mechanisms for enhancement of the corrosion rate are discussed.

A preoperative retrobulbar block in patients undergoing scleral buckling reduces pain, endogenous stress response, and improves vigilance.

BACKGROUND AND OBJECTIVES: This study aims to test postoperative analgesia by using retrobulbar block in patients with retinal detachment surgery. METHODS: Twenty-nine patients scheduled for scleral buckling were included in this double-blind, randomized, prospective study. After induction of general anesthesia and opening of the conjunctiva, patients received either 4 mL bupivacaine 0.5% or 4 mL saline 0.9% injected into the retrobulbar space preoperatively. Heart rate and blood pressure were documented before the start of anesthesia, 10 and 50 minutes later, and 60 minutes after completion of surgery. At the same time points, 10 mL of blood were withdrawn for measurement of glucose and cortisol levels to evaluate the efficacy of retrobulbar block in eliminating humoral response. Postoperative scores for pain and vigilance were recorded 1, 6, and 24 hours after completion of surgery. The application of analgesic and antiemetic drugs was documented, as well as occurrence of nausea and vomiting. RESULTS: A preoperative retrobulbar block in patients undergoing scleral buckling reduces pain, endogenous stress response, and improves vigilance. CONCLUSIONS: Because the analgesic effect of the retrobulbar block was considerably longer than pharmacologically expected, the combined retrobulbar and general anesthesia "protects" against postoperative pain and is recommended for patients undergoing scleral buckling.