{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T11:42:09Z","timestamp":1784720529778,"version":"3.55.0"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T00:00:00Z","timestamp":1695081600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T00:00:00Z","timestamp":1695081600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100013000","name":"Politecnico di Torino","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100013000","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Biomed Eng"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Mechanical tests on bone plates are mandatory for regulatory purposes and, typically, the ASTM F382 standard is used, which involves a four-point bending test setup to evaluate the cyclic bending fatigue performance of the bone plate. These test campaigns require a considerable financial outlay and long execution times; therefore, an accurate prediction of experimental outcomes can reduce test runtime with beneficial cost cuts for manufacturers. Hence, an analytical framework is here proposed for the direct estimation of the maximum bending moment of a bone plate under fatigue loading, to guide the identification of the runout load for regulatory testing. Eleven bone plates awaiting certification were subjected to a comprehensive testing campaign following ASTM F382 protocols to evaluate their static and fatigue bending properties. An analytical prediction of the maximum bending moment was subsequently implemented based on ultimate strength and plate geometry. The experimental loads obtained from fatigue testing were then used to verify the prediction accuracy of the analytical approach. Results showed promising predictive ability, with <jats:italic>R<\/jats:italic><jats:sup>2<\/jats:sup> coefficients above 0.95 in the runout condition, with potential impact in reducing the experimental tests needed for the CE marking of bone plates.<\/jats:p>","DOI":"10.1007\/s10439-023-03363-2","type":"journal-article","created":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T19:01:45Z","timestamp":1695150105000},"page":"239-249","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Bone Plates Runout Prediction Through Tensile Strength and Geometric Properties for Regulatory Mechanical Testing"],"prefix":"10.1007","volume":"52","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3596-6078","authenticated-orcid":false,"given":"Federico Andrea","family":"Bologna","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto Luigi","family":"Audenino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mara","family":"Terzini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,9,19]]},"reference":[{"key":"3363_CR1","doi-asserted-by":"publisher","first-page":"1128","DOI":"10.3390\/ma12071128","volume":"12","author":"IV Antoniac","year":"2019","unstructured":"Antoniac, I. V., D. I. Stoia, B. Ghiban, C. Tecu, F. Miculescu, C. Vigaru, and V. Saceleanu. Failure analysis of a humeral shaft locking compression plate-surface investigation and simulation by finite element method. Materials (Basel). 12:1128, 2019.","journal-title":"Materials (Basel)"},{"key":"3363_CR2","doi-asserted-by":"publisher","unstructured":"ASTM International. Standard Specification and Test Method for Metallic Bone Plates F382-99. West Conshohocken, USA, 2017.https:\/\/doi.org\/10.1520\/F0382-17.Copyright.","DOI":"10.1520\/F0382-17.Copyright"},{"key":"3363_CR3","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1016\/S1350-6307(02)00067-5","volume":"10","author":"CRF Azevedo","year":"2003","unstructured":"Azevedo, C. R. F. Failure analysis of a commercially pure titanium plate for osteosynthesis. Eng. Fail. Anal. 10:153\u2013164, 2003.","journal-title":"Eng. Fail. Anal."},{"key":"3363_CR4","doi-asserted-by":"publisher","first-page":"35","DOI":"10.4081\/bse.2021.154","volume":"4","author":"FA Bologna","year":"2021","unstructured":"Bologna, F. A., M. Terzini, A. T. Lugas, and A. L. Audenino. Minimum performance level definition for bone plate testing according to standard: a preliminary study. Biomed. Sci. Eng. 4:35\u201336, 2021.","journal-title":"Biomed. Sci. Eng."},{"key":"3363_CR5","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1016\/S1350-4533(00)00062-X","volume":"22","author":"F Burny","year":"2000","unstructured":"Burny, F., M. Donkerwolcke, F. Moulart, R. Bourgois, R. Puers, K. Van Schuylenbergh, M. Barbosa, O. Paiva, F. Rodes, J. B. B\u00e9gueret, and P. Lawes. Concept, design and fabrication of smart orthopedic implants. Med. Eng. Phys. 22:469\u2013479, 2000.","journal-title":"Med. Eng. Phys."},{"key":"3363_CR6","doi-asserted-by":"publisher","first-page":"163","DOI":"10.1111\/j.1460-2695.2008.01322.x","volume":"32","author":"NE Dowling","year":"2009","unstructured":"Dowling, N. E., C. A. Calhoun, and A. Arcari. Mean stress effects in stress-life fatigue and the Walker equation. Fatigue Fract. Eng. Mater. Struct. 32:163\u2013179, 2009.","journal-title":"Fatigue Fract. Eng. Mater. Struct."},{"key":"3363_CR7","doi-asserted-by":"publisher","first-page":"101","DOI":"10.2478\/scjme-2021-0021","volume":"71","author":"V Dr\u00e1tovsk\u00e1","year":"2021","unstructured":"Dr\u00e1tovsk\u00e1, V., R. Sedl\u00e1\u010dek, Z. Padovec, P. R\u016f\u017ei\u010dka, and A. Kratochv\u00edl. The mechanical properties and fatigue prediction of a new generation of osteosynthesis devices. Strojn\u00edcky \u010dasopis \u2013 J. Mech. Eng. 71:101\u2013108, 2021.","journal-title":"Strojn\u00edcky \u010dasopis \u2013 J. Mech. Eng."},{"key":"3363_CR8","unstructured":"Food and Drug Administration. Orthopedic Fracture Fixation Plates\u2014Performance Criteria for Safety and Performance Based Pathway\u2014Guidance for Industry and Food and Drug Administration Staff. Rockville, USA: 2022. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfStandards\/search.cfm."},{"key":"3363_CR9","unstructured":"International Organization for Standardization. ISO 14602. Non-active surgical implants\u2014implants for osteosynthesis\u2014particular requirements. Geneva, Switzerland, 2010."},{"key":"3363_CR10","volume-title":"Fundamentals of Machine Component Design","author":"RC Junivall","year":"2017","unstructured":"Junivall, R. C., and K. M. Marshek. Fundamentals of Machine Component Design. New York: Wiley, 2017."},{"key":"3363_CR11","doi-asserted-by":"publisher","first-page":"645","DOI":"10.1007\/s40430-016-0598-3","volume":"39","author":"PP Kenedi","year":"2017","unstructured":"Kenedi, P. P., and L. L. Vignoli. An osteosynthesis plate analytical model. J. Braz. Soc. Mech. Sci. Eng. 39:645\u2013659, 2017.","journal-title":"J. Braz. Soc. Mech. Sci. Eng."},{"key":"3363_CR12","unstructured":"Legland, D. geom3d. MATLAB Central File Exchange, 2019. https:\/\/www.mathworks.com\/matlabcentral\/fileexchange\/24484-geom3d."},{"key":"3363_CR13","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1016\/j.tcr.2018.09.005","volume":"17","author":"G Logroscino","year":"2018","unstructured":"Logroscino, G., F. Donati, M. Saracco, L. Pilloni, and C. Piconi. Trauma Case Reports Early failure of a locked titanium plate in a proximal humeral fracture: case report and metallurgic analysis. Trauma Case Rep. 17:18\u201322, 2018.","journal-title":"Trauma Case Rep."},{"key":"3363_CR14","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1016\/0045-7949(84)90133-0","volume":"18","author":"J Mar\u00edn","year":"1984","unstructured":"Mar\u00edn, J. Computing columns, footings and gates through moments of area. Comput. Struct. 18:343\u2013349, 1984.","journal-title":"Comput. Struct."},{"key":"3363_CR15","doi-asserted-by":"crossref","unstructured":"Mitchell, M. R. Fundamentals of modern fatigue analysis for design. In: ASM Handbook 19 Fatigue and Fracture. Materials Park, USA: ASM International, pp. 242\u2013243, 1996.","DOI":"10.31399\/asm.hb.v19.a0002364"},{"key":"3363_CR16","doi-asserted-by":"publisher","first-page":"105663","DOI":"10.1016\/j.clinbiomech.2022.105663","volume":"96","author":"B Muthusamy","year":"2022","unstructured":"Muthusamy, B., C. K. Chao, S. J. Su, C. W. Cheng, and J. Lin. Effects of merged holes, partial thread removal, and offset holes on fatigue strengths of titanium locking plates. Clin. Biomech. 96:105663, 2022.","journal-title":"Clin. Biomech."},{"key":"3363_CR17","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3389\/fbioe.2023.1133869","volume":"11","author":"M Nakhaei","year":"2023","unstructured":"Nakhaei, M., M. Sterba, J. M. Foletti, L. Badih, and M. Behr. Experimental analysis and numerical fatigue life prediction of 3D-Printed osteosynthesis plates. Front. Bioeng. Biotechnol. 11:1\u201313, 2023.","journal-title":"Front. Bioeng. Biotechnol."},{"key":"3363_CR18","doi-asserted-by":"publisher","unstructured":"Pilkey, W. D. Peterson\u2019s Stress Concentration Factors. New York, USA: Wiley, pp 135\u2013175, 2008. https:\/\/doi.org\/10.1002\/9780470211106.ch3.","DOI":"10.1002\/9780470211106.ch3"},{"key":"3363_CR19","unstructured":"Programoeto. PolygonMoments. MATLAB Central File Exchange, 2023. https:\/\/www.mathworks.com\/matlabcentral\/fileexchange\/55672-polygonmoments."},{"key":"3363_CR20","unstructured":"Rossetto, M. Introduzione alla fatica dei materiali e dei componenti meccanici. Torino: Levrotto & Bella, 2000."},{"key":"3363_CR21","doi-asserted-by":"publisher","first-page":"235","DOI":"10.1515\/bmt-2015-0219","volume":"62","author":"H Schorler","year":"2017","unstructured":"Schorler, H., F. Capanni, M. Gaashan, R. Wendlandt, C. J\u00fcrgens, and A. P. Schulz. Bone plates for osteosynthesis\u2014a systematic review of test methods and parameters for biomechanical testing. Biomed. Tech. 62:235\u2013243, 2017.","journal-title":"Biomed. Tech."},{"key":"3363_CR22","doi-asserted-by":"publisher","first-page":"408","DOI":"10.1016\/j.injury.2010.11.058","volume":"42","author":"RC Sproul","year":"2011","unstructured":"Sproul, R. C., J. J. Iyengar, Z. Devcic, and B. T. Feeley. A systematic review of locking plate fixation of proximal humerus fractures. Injury. 42:408\u2013413, 2011.","journal-title":"Injury"},{"key":"3363_CR23","doi-asserted-by":"publisher","first-page":"1","DOI":"10.3389\/fbioe.2020.00619","volume":"8","author":"M Terzini","year":"2020","unstructured":"Terzini, M., A. Aldieri, S. Nurisso, G. De Nisco, and C. Bignardi. Finite element modeling application in forensic practice: a periprosthetic femoral fracture case study. Front. Bioeng. Biotechnol. 8:1\u201311, 2020.","journal-title":"Front. Bioeng. Biotechnol."},{"key":"3363_CR24","unstructured":"Terzini, M., G. Serino, A. T. Lugas, G. Dichio, P. Costa, and A. L. Audenino. Strategies to speed up the standardized bone plates mechanical testing for regulatory purposes. Convegno Naz. di Bioingegneria, pp. 317\u2013320, 2020."},{"key":"3363_CR25","volume-title":"Theory of elasticity","author":"SP Timoshenko","year":"1970","unstructured":"Timoshenko, S. P., and J. N. Goodier. Theory of elasticity. New York: McGraw-Hill, 1970."},{"key":"3363_CR26","doi-asserted-by":"publisher","first-page":"2726","DOI":"10.1016\/j.injury.2016.09.036","volume":"47","author":"WJ Tseng","year":"2016","unstructured":"Tseng, W. J., C. K. Chao, C. C. Wang, and J. Lin. Notch sensitivity jeopardizes titanium locking plate fatigue strength. Injury. 47:2726\u20132732, 2016.","journal-title":"Injury"},{"key":"3363_CR27","first-page":"202","volume":"3","author":"V Wagare","year":"2015","unstructured":"Wagare, V., and R. Hundekari. Fatigue life and damage prediction of plate with central hole using finite element method. J. Mater. Sci. Surf. Eng. Fatigue. 3:202\u2013206, 2015.","journal-title":"J. Mater. Sci. Surf. Eng. Fatigue"},{"key":"3363_CR28","doi-asserted-by":"publisher","first-page":"1671","DOI":"10.1016\/j.jcms.2017.07.010","volume":"45","author":"CH Wu","year":"2017","unstructured":"Wu, C. H., Y. S. Lin, Y. S. Liu, and C. L. Lin. Biomechanical evaluation of a novel hybrid reconstruction plate for mandible segmental defects: a finite element analysis and fatigue testing. J. Cranio-Maxillofacial Surg. 45:1671\u20131680, 2017.","journal-title":"J. Cranio-Maxillofacial Surg."},{"key":"3363_CR29","doi-asserted-by":"publisher","first-page":"300","DOI":"10.3390\/prosthesis3040028","volume":"3","author":"B Ziaie","year":"2021","unstructured":"Ziaie, B., and S. M. R. Khalili. Evaluation of fatigue life for dental implants using FEM analysis. Prosthesis. 3:300\u2013313, 2021.","journal-title":"Prosthesis"}],"container-title":["Annals of Biomedical Engineering"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10439-023-03363-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10439-023-03363-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10439-023-03363-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,24]],"date-time":"2024-01-24T16:15:14Z","timestamp":1706112914000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10439-023-03363-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,19]]},"references-count":29,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["3363"],"URL":"https:\/\/doi.org\/10.1007\/s10439-023-03363-2","relation":{},"ISSN":["0090-6964","1573-9686"],"issn-type":[{"value":"0090-6964","type":"print"},{"value":"1573-9686","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,19]]},"assertion":[{"value":"5 May 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 September 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 September 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All authors declare that they have no financial ties or conflict of interest to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}