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Preclinical in vivo research of magnesium-based implants for fracture treatment: A systematic review of animal model selection and study design

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Journal of Magnesium and Alloys 2021年第2期9卷 351-361页

作者： Yu Sun heike helmholz Regine Willumeit-Römera Division of Metallic Biomaterials Institute of Materials ResearchHelmholtz-Zentrum Geesthacht21502 GeesthachtGermany Department of Orthopedics First Hospital of China Medical UniversityShenyang 110001China

Background:Degradable magnesium implants are promising for clinical fracture treatment,providing less stress-shielding mechanical support and superior bone-strengthening benefits to traditional *** quality of preclinical research is essential for developing Mg implants;however,there are considerable variations in the model selection and study design in published studies,posing challenges for safe and effective clinical translation of lab ***:The purpose of this systematic review is to investigate the current progress on in vivo research of Mg implants for fracture treatment,focusing on model selection,Mg materials,implant design,methodological and analyzing techniques,aiming to provide comprehensive guidance for future preclinical *** and methods:Pub Med and Embase online databases were searched to identify researches investigating Mg implants in animal models of fracture from 1960 to December 2019,using a combination of keywords:magnesium and *** studies were included without language *** extraction was conducted for qualitative ***-analysis was not performed due to extensive heterogeneities among ***:Twenty studies published from 2014 to 2019 were *** information,animal model,methodological quality,implants preparation,and evaluation techniques were *** methodological assessment revealed low to high risk of bias among *** rodent and non-rodent species were selected,and the anatomical sites for inducing fractures included both cranial-facial and limb *** Mg and alloys with or without surface modification were evaluated,covering implant designs of both intra-medullary and extra-medullary *** and histological evaluations were commonly ***:Published in vivo evidence confirmed the role of Mg-based implants in promoting fracture ***,considering heterogeneity in animal selection,implant prep

关键词： Magnesium Implant Fracture Animal model Study design Biomaterial

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Peri-implant gas accumulation in response to magnesium-based musculoskeletal biomaterials:Reframing current evidence for preclinical research and clinical evaluation

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Journal of Magnesium and Alloys 2024年第1期12卷 59-71页

作者： Yu Sun heike helmholz Regine Willumeit-Römer Institute of Metallic Biomaterials Helmholtz-Zentrum HereonMax-Planck-Str.1Geesthacht 21502Germany

Historically,the rapid degradation and massive gas release from magnesium(Mg)implants resulted in severe emphysema and mechanical *** the advent of new alloys and surface treatment methods,optimized Mg implants have re-entered clinics since last decade with reliable ***,the optimization aims at slowing down the degradation process,rather than exemption of the gas *** study involved a systematic evaluation of current preclinical and clinical evidence,regarding the physical signs,symptoms,radiological features,pathological findings and complications potentially associated with peri±implant gas accumulation(PIGA)after musculoskeletal Mg *** literature search identified 196 potentially relevant publications,and 51 papers were enrolled for further analysis,including 22 preclinical tests and 29 clinical studies published from 2005 to *** Mg-based materials have been evaluated in animal research,and the application of pure Mg and Mg alloys have been reported in clinical follow-ups involving multiple anatomical sites and musculoskeletal *** tissue and intraosseous PIGA are common in both animal tests and clinical follow-ups,and potentially associated with certain adverse *** examinations especially micro-CT and clinical CT scans provide valuable information for quantitative and longitudinal *** according to simulation tests involving Mg implantation and chemical processing,tissue fixation could lead to an increase in the volume of gas cavity,thus the results obtained from ex vivo imaging or histopathological evaluations should be interpreted with *** still lacks standardized procedures or consensus for both preclinical and clinical evaluation of ***,by providing focused insights into the topic,this evidence-based study will facilitate future animal tests and clinical evaluations,and support developing biocompatible Mg implants for the treatment of musculoskeletal

关键词： Magnesium implant Degradation Hydrogen Gas release Postoperative follow-up

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Systemic modulation of skeletal mineralization by magnesium implant promoting fracture healing: Radiological exploration enhanced with PCA-based machine learning in a rat femoral model

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Journal of Magnesium and Alloys 2024年第3期12卷 1009-1020页

作者： Yu Sun heike helmholz Regine Willumeit-Römer Institute of Metallic Biomaterials Helmholtz-Zentrum HereonGermany

The clinical application of magnesium(Mg)and its alloys for bone fractures has been well supported by in vitro and in vivo ***,there were studies indicating negative effects of high dose Mg intake and sustained local release of Mg ions on bone metabolism or repair,which should not be ignored when developing Mg-based ***,it remains necessary to assess the biological effects of Mg implants in animal models relevant to clinical treatment *** primary purpose of this study was to validate the beneficial effects of intramedullary Mg implants on the healing outcome of femoral fractures in a modified rat *** addition,the mineralization parameters at multiple anatomical sites were evaluated,to investigate their association with healing outcome and potential clinical *** to the control group without Mg implantation,postoperative imaging at week 12 demonstrated better healing outcomes in the Mg group,with more stable unions in 3D analysis and high-mineralized bridging in 2D *** bone tissue mineral density(TMD)was higher in the Mg group at the non-operated femur and lumbar vertebra,while no differences between groups were identified regarding the bone tissue volume(TV),TMD and bone mineral content(BMC)in *** the surgical femur,the Mg group presented higher TMD,but lower TV and BMC in the distal metaphyseal region,as well as reduced BMC at the osteotomy *** component analysis(PCA)-based machine learning revealed that by selecting clinically relevant parameters,radiological markers could be constructed for differentiation of healing outcomes,with better performance than 2D *** study provides insights and preclinical evidence for the rational investigation of bioactive materials,the identification of potential adverse effects,and the promotion of diagnostic capabilities for fracture healing.

关键词： Magnesium Implants Bone fracture Mineralization Systemic modulation Principal component analysis.

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Effects of proteins on magnesium degradation-static *** conditions

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Journal of Magnesium and Alloys 2023年第4期11卷 1332-1342页

作者： Ruiqing Hou Frank Feyerabend heike helmholz Vasil M.Garamus Regine Willumeit-Römer School of Materials Science and Engineering&Henan Key Laboratory of Advanced Magnesium Alloys Zhengzhou UniversityNo.100 Science AvenueZhengzhou 450001China Institute of Metallic Biomaterials Helmholtz-Zentrum Hereon(Hereon)Max-Planck-Str.1Geesthacht 21502Germany

The interaction between organic molecules and biomaterial surfaces determines the fate of biomaterials during their service life,which is also the research hotspots in the field of *** understand the mechanism of protein interaction with magnesium(Mg)degradation,alloying elements,immersion time,protein concentration and surface conditions have been previously considered for the effect of proteins on Mg ***,fluid flow,as one of the critical factors,drew little attention in this *** the present study,the effect of bovine serum albumin(BSA)and fetal bovine serum(FBS)on Mg degradation was compared under static and dynamic *** results revealed that both BSA and FBS slightly decreased the degradation rate of Mg in Hanks’balanced salt solution(HBSS)under static immersion due to the protein adsorption and the formation of a Ca/P-rich top layer on Mg surface,whereas under dynamic flow condition the degradation of Mg was significantly accelerated in the presence of BSA or *** reasons seemed to stem from the weakened protein adsorption on Mg surface in this case and the dynamically enhanced interaction between proteins and ions/products in solutions,which largely weaken the combination of the top Ca/P-rich layer with the inner corrosion product *** results highlight the importance of testing conditions for Mg characterization in vitro and the synergistic effect between different parameters on Mg degradation.

关键词： Flow Bovine serum albumin Fetal bovine serum Protein adsorption

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Treatment of osteoarthritis by implantation of Mg- and WE43-cylinders - A preclinical study on bone and cartilage changes and their influence on pain sensation in rabbits

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Bioactive Materials 2024年第10期40卷 366-377页

作者： Nina Angrisani Christin von der Ahe Regine Willumeit-R¨omer Henning Windhagen Verena Scheper Michael Schwarze Bj¨orn Wiese heike helmholz Janin Reifenrath Hannover Medical School Clinic for Orthopaedic SurgeryLower Saxony Centre for Biomedical EngineeringImplant Research and Development(NIFE)HannoverLower SaxonyGermany Helmholtz-Zentrum Hereon Institute of Metallic BiomaterialsGeesthachtGermany Hannover Medical School Department of OtolaryngologyLower Saxony Centre for Biomedical EngineeringImplant Research and Development(NIFE)HannoverLower SaxonyGermany Hannover Medical School Clinic for Orthopaedic SurgeryLaboratory for Biomechanics and BiomaterialsHannoverLower SaxonyGermany

With its main features of cartilage degeneration, subchondral bone sclerosis and osteophyte formation, osteoarthritisrepresents a multifactorial disease with no effective treatment options. As biomechanical shift in thetrabecular network may be a driver for further cartilage degeneration, bone enhancement could possibly delayOA progression. Magnesium is known to be osteoconductive and already showed positive effects in OA *** aimed to use magnesium cylinders to enhance subchondral bone quality, condition of cartilage and painsensation compared to sole drilling in vivo. After eight weeks of implantation in rabbits, significant increase insubchondral bone volume and trabecular thickness with constant bone mineral density was found indicatingfavored biomechanics. As representative for pain, a higher number of CD271+ vessels were present in controlsamples without magnesium. However, this result could not be confirmed by sensitive, objective lamenessevaluation using a pressure sensing mat and no positive effect could be shown on either cartilage degenerationevaluated by OARSI score nor the presence of regenerative cells in CD271-stained samples. The presented resultsshow a relevant impact of implanted magnesium on key structures in OA pain with missing clinical relevanceregarding pain. Further studies with shifted focus should examine additional structures as joint capsule orosteophytes.

关键词： Magnesium Subchondral bone In vivo Gait analysis μ-computed tomography CD271

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In vitro and in vivo degradation behavior of Mg-0.45Zn-0.45Ca(ZX00)screws for orthopedic applications

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Bioactive Materials 2023年第10期28卷 132-154页

作者： Diana C.Martinez Anna Dobkowska Romy Marek Hanna Cwieka Jakub Jaroszewicz Tomasz Płocinski Crtomir Donik heike helmholz Berengere Luthringer-Feyerabend Berit Zeller-Plumhoff Regine Willumeit-Romer Wojciech Swięszkowski Biomaterials Group Materials Design DivisionFaculty of Materials Science and EngineeringWarsaw University of TechnologyWołoska 14102-507WarsawPoland Department of Orthopedics and Traumatology Medical University of GrazAuenbruggerplatz 58036GrazAustria Institute of Metallic Biomaterials Helmholtz-Zentrum Hereon GmbH21502GeesthachtGermany Department of Physics and Chemistry of Materials Institute of Metals and TechnologyUniversity of Ljubljan1Lepi Pot 11SI-1000Ljubljan1Slovenia

Magnesium (Mg) alloys have become a potential material for orthopedic implants due to their unnecessary implant removal, biocompatibility, and mechanical integrity until fracture healing. This study examined the in vitro and in vivo degradation of an Mg fixation screw composed of Mg-0.45Zn-0.45Ca (ZX00, in wt.%). With ZX00 human-sized implants, in vitro immersion tests up to 28 days under physiological conditions, along with electrochemical measurements were performed for the first time. In addition, ZX00 screws were implanted in the diaphysis of sheep for 6, 12, and 24 weeks to assess the degradation and biocompatibility of the screws in vivo. Using scanning electron microscopy (SEM) coupled with energy dispersive X-ray spectroscopy (EDX), micro-computed tomography (μCT), X-ray photoelectron spectroscopy (XPS), and histology, the surface and cross-sectional morphologies of the corrosion layers formed, as well as the bone-corrosion-layer-implant interfaces, were analyzed. Our findings from in vivo testing demonstrated that ZX00 alloy promotes bone healing and the formation of new bone in direct contact with the corrosion products. In addition, the same elemental composition of corrosion products was observed for in vitro and in vivo experiments;however, their elemental distribution and thicknesses differ depending on the implant location. Our findings suggest that the corrosion resistance was microstructure-dependent. The head zone was the least corrosion-resistant, indicating that the production procedure could impact the corrosion performance of the implant. In spite of this, the formation of new bone and no adverse effects on the surrounding tissues demonstrated that the ZX00 is a suitable Mg-based alloy for temporary bone implants.

关键词： Magnesium alloys Biodegradable implants Microstructure Electron microscopy Corrosion layers

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Multi-modal investigation of the bone micro- and ultrastructure, and elemental distribution in the presence of Mg-xGd screws at mid-term healing stages

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Bioactive Materials 2024年第11期41卷 657-671页

作者： Kamila Iskhakova Hanna Cwieka Svenja Meers heike helmholz Anton Davydok Malte Storm Ivo Matteo Baltruschat Silvia Galli Daniel Pröfrock Olga Will Mirko Gerle Timo Damm Sandra Sefa Weilue He Keith MacRenaris Malte Soujon Felix Beckmann Julian Moosmann Thomas O'Hallaran Roger J.Guillory II D.C.Florian Wieland Berit Zeller-Plumhoff Regine Willumeit-Römer florian wieland berit zeller-plumhoffregine willumeit-römer1institute of metallic biomaterialshelmholtz zentrum hereongeesthachtgermany institute of materials physiscs helmholtz zentrum hereongeesthachtgermany deutsches elektronen-synchrotron desy hamburggermany department of prosthodontics faculty of odontologyuniversity of malmömalmösweden institute of coastal environmental chemistry helmholtz zentrum hereongeesthachtgermany molecular imaging north competence center kiel universitykielgermany the department of oral and maxillofacial surgery campus kiel ukshkielgermany department of biomedical engineering michigan technological universityusa department of microbiology and biochemistry michigan state universityusa joint department of biomedical engineering medical college of wisconsinusa institute of materials mechanics helmholtz zentrum hereongeesthachtgermany

Magnesium(Mg)–based alloys are becoming attractive materials for medical applications as temporary bone implants for support of fracture healing,*** a suture *** to their mechanical properties and biocompatibility,they may replace titanium or stainless-steel implants,commonly used in orthopedic ***,patient safety has to be assured by finding a long-term balance between metal degradation,osseointegration,bone ultrastructure adaptation and element distribution in *** order to determine the implant behavior and its influence on bone and tissues,we investigated two Mg alloys with gadolinium contents of 5 and 10 wt percent in comparison to permanent materials titanium and polyether ether *** implants were present in rat tibia for 10,20 and 32 weeks before sacrifice of the *** radiation-based micro computed tomography enables the distinction of features like residual metal,degradation layer and bone ***,X-ray diffraction and X-ray fluorescence yield information on parameters describing the bone ultrastructure and elemental composition at the bone-to-implant ***,with element specific mass spectrometry,the elements and their accumulation in the main organs and tissues are *** results show that Mg-xGd implants degrade in vivo under the formation of a stable degradation layer with bone remodeling similar to that of Ti after 10 *** accumulation of Mg and Gd was observed in selected organs,except for the interfacial bone after 8 months of ***,we confirm that Mg-5Gd and Mg-10Gd are suitable material choices for bone implants.

关键词： Biodegradable implants Bone ultrastructure Degradation Mg-based alloys

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