The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic bioma...The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic biomaterials(PMBs)’with demonstrated research and application case studies of pure titanium with high strength and toughness,and biodegradable,fine-grained and high-purity magnesium.Then,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory aspects.Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.展开更多
Biodegradable metals are promising candidates for bone defect repair.With an evidence-based approach,this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal mo...Biodegradable metals are promising candidates for bone defect repair.With an evidence-based approach,this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal models for bone defect repair to explore their potential clinical translation.Animal studies on bone defect repair with biodegradable metals in comparison with other traditional biomaterials were reviewed.Data was carefully collected after identification of population,intervention,comparison,outcome,and study design(PICOS),and following the inclusion criteria of biodegradable metals in animal studies.30 publications on pure Mg,Mg alloys,pure Zn and Zn alloys were finally included after extraction from a collected database of 2543 publications.A qualitative systematic review and a quantitative meta-analysis were performed.Given the heterogeneity in animal model,anatomical site and critical size defect(CSD),biodegradable metals exhibited mixed effects on bone defect repair and degradation in animal studies in comparison with traditional non-degradable metals,biodegradable polymers,bioceramics,and autogenous bone grafts.The results indicated that there were limitations in the experimental design of the included studies,and quality of the evidence presented by the studies was very low.To enhance clinical translation of biodegradable metals,evidence-based research with data validity is needed.Future studies should adopt standardized experimental protocols in investigating the effects of biodegradable metals on bone defect repair with animal models.展开更多
基金supported by the first batch of Chinese Drug Regulatory Science Action Plan(Regulatory science research on new materi-als for medical device)This work was also supported by the sec-ond batch(“5.5 Research on technical evaluation of recombinant collagens,cartilage repair materials and antimicrobial orthope-dic/dental materials”)of Chinese Drug Regulatory Science Action Plan of NMPA.
文摘The‘plainification of materials’has been conceptualized to promote the sustainable development of materials.This perspective,for the first time in the field of biomaterials,proposes and defines‘plain metallic biomaterials(PMBs)’with demonstrated research and application case studies of pure titanium with high strength and toughness,and biodegradable,fine-grained and high-purity magnesium.Then,after discussing the features,benefits and opportunities of PMBs,the challenges are analyzed from both technical and regulatory aspects.Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research,development and commercialization.
文摘Biodegradable metals are promising candidates for bone defect repair.With an evidence-based approach,this study investigated and analyzed the performance and degradation properties of biodegradable metals in animal models for bone defect repair to explore their potential clinical translation.Animal studies on bone defect repair with biodegradable metals in comparison with other traditional biomaterials were reviewed.Data was carefully collected after identification of population,intervention,comparison,outcome,and study design(PICOS),and following the inclusion criteria of biodegradable metals in animal studies.30 publications on pure Mg,Mg alloys,pure Zn and Zn alloys were finally included after extraction from a collected database of 2543 publications.A qualitative systematic review and a quantitative meta-analysis were performed.Given the heterogeneity in animal model,anatomical site and critical size defect(CSD),biodegradable metals exhibited mixed effects on bone defect repair and degradation in animal studies in comparison with traditional non-degradable metals,biodegradable polymers,bioceramics,and autogenous bone grafts.The results indicated that there were limitations in the experimental design of the included studies,and quality of the evidence presented by the studies was very low.To enhance clinical translation of biodegradable metals,evidence-based research with data validity is needed.Future studies should adopt standardized experimental protocols in investigating the effects of biodegradable metals on bone defect repair with animal models.
