{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T15:40:03Z","timestamp":1778082003175,"version":"3.51.4"},"reference-count":49,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T00:00:00Z","timestamp":1693267200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal Orthopaedic Research"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Biointegrative, mineral fiber\u2010reinforced bone fixation implants recently introduced in orthopedic surgery have expanded available treatment options for fractures and bone deformities. This new technology aims to address the disadvantages of permanent metallic implants while overcoming inherent concerns of adverse inflammatory reactions when using polymer\u2010based orthopedic implants. The purpose of this double\u2010arm preclinical study was to evaluate the safety, biocompatibility, and biointegration of fiber\u2010reinforced plates, following implantation on the tibias of eight sheep. Left tibias underwent periosteal elevation, allowing for implant attachment directly onto the cortical surface; right tibia plates were implanted over intact periosteum. Microcomputed tomography and histopathology were performed at 13, 26, 52, 78, 104, and 134 weeks postimplantation. All animals were evaluated clinically at each time point, with no evidence of local adverse reactions. Histopathology demonstrated anti\u2010inflammatory M2\u2010like macrophages and multinucleated giant cells corresponding to implant bioabsorption, similar for both groups at each time point, and indicating expected implant biocompatibility. Inflammatory cells (i.e., eosinophils, lymphophyctes, plasma cells, and M1\u2010like macrophages) were absent throughout the study. The bioabsorption process had started at 13\u2009W, with the highest rate at 52\u201378\u2009W. At 104\u2009W, only residual polymer material was left (\u223c5% of implant area). Low amounts of mineral fibers were evident at 78\u2009W and were absent (fully remodeled) by 104\u2009W. At 134\u2009W, implants at both sites were fully bioabsorbed. In conclusion, these new fiber\u2010reinforced implants demonstrated bone remodeling and complete biointegration, with no adverse tissue response. Clinical significance: In this double\u2010arm, 2.5\u2010year study, a biointegrative, fiber\u2010reinforced plate implanted on the tibias of sheep was fully absorbed within 134 weeks, with no adverse tissue reaction. Bioabsorption was similar, with or without periosteal elevation, mimicking conditions like those observed in traumatic injuries disrupting the periosteum, open reduction and internal fixation, or minimally invasive surgeries. These results demonstrate the feasibility, versatility, and safety of this new class of biointegrative bone implants. This newly developed technology avoids the complications of the removal of metal implants.<\/jats:p>","DOI":"10.1002\/jor.25682","type":"journal-article","created":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T08:21:14Z","timestamp":1692433274000},"page":"360-372","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The biointegration profile of fiber\u2010reinforced plates following tibial implantation in sheep"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1418-0551","authenticated-orcid":false,"given":"Nicolette D.","family":"Jackson","sequence":"first","affiliation":[{"name":"Inotiv Fort Collins Colorado USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7847-2513","authenticated-orcid":false,"given":"Abraham","family":"Nyska","sequence":"additional","affiliation":[{"name":"Tel Aviv University  Tel Aviv Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ezequiel","family":"Palmanovich","sequence":"additional","affiliation":[{"name":"Meir Medical Center Kfar Saba Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meir","family":"Nyska","sequence":"additional","affiliation":[{"name":"Meir Medical Center Kfar Saba Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,29]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.engreg.2020.05.003"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/BOT.0000000000000467"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1741-7015-9-66"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.blo.0000205884.81328.cc"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1586\/17434440.1.2.229"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biomaterials.2004.02.005"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.5435\/00124635-200802000-00009"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.injury.2017.10.010"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0020-1383(18)30311-5"},{"key":"e_1_2_7_11_1","first-page":"63","article-title":"Principles of fracture healing and disorders of bone union","volume":"27","author":"Jahagirdar R","year":"2009","journal-title":"Surgery"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ctsap.2004.09.002"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/00005131-200409000-00003"},{"key":"e_1_2_7_14_1","first-page":"71","article-title":"Biomaterials in orthopedic bone plates: a review","volume":"2011","author":"Malekani J","year":"2011","journal-title":"Met Manuf Glob Sci Technol Forum"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bioactmat.2022.01.015"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.7181\/acfs.2016.17.1.1"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fas.2009.02.008"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1260\/2040-2295.3.2.243"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcms.2013.01.026"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tripleo.2004.02.069"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdsr.2018.03.003"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/polym14081526"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1159\/000348328"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(85)91847-1"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.7181\/acfs.2019.00409"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0749-8063(00)90055-0"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.2174\/1567201818666210510165938"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/adhm.201700694"},{"key":"e_1_2_7_29_1","unstructured":"Preiss\u2010BloomOPD Merchav\u2010FeurmannR LindnerT. OSSIOfiber(TM) intelligent bone regeneration technology overview. OSSIO Inc. DOC000625.2019. Accessed August 26 2023.https:\/\/resources.ossio.io\/white-paper-on-the-ossiofiber-technology"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/jbm.820050611"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biomaterials.2003.09.081"},{"key":"e_1_2_7_32_1","doi-asserted-by":"crossref","DOI":"10.1177\/2473011420S00127","article-title":"Bio\u2010integration and bone fixation performance of continuous mineral fiber\u2010reinforced implants","volume":"5","author":"Berlet GC","year":"2020","journal-title":"Foot Ankle Orthop"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1177\/0192623318816681"},{"key":"e_1_2_7_34_1","volume-title":". ISO 10993\u20106:2016(en) Biological Evaluation of Medical Devices\u2014Part 6: Tests for Local Effects after Implantation","author":"International Organization for Standardization","year":"2016"},{"key":"e_1_2_7_35_1","doi-asserted-by":"publisher","DOI":"10.1177\/01926233221103202"},{"key":"e_1_2_7_36_1","doi-asserted-by":"publisher","DOI":"10.1177\/0192623315623265"},{"key":"e_1_2_7_37_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2015.00215"},{"key":"e_1_2_7_38_1","doi-asserted-by":"publisher","DOI":"10.1021\/acsabm.0c00060"},{"key":"e_1_2_7_39_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.immuni.2016.02.015"},{"key":"e_1_2_7_40_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI59643"},{"key":"e_1_2_7_41_1","doi-asserted-by":"publisher","DOI":"10.1002\/path.4133"},{"key":"e_1_2_7_42_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12031-019-01361-5"},{"key":"e_1_2_7_43_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2474-7-67"},{"key":"e_1_2_7_44_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41596-019-0271-2"},{"key":"e_1_2_7_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fas.2022.06.013"},{"key":"e_1_2_7_46_1","doi-asserted-by":"publisher","DOI":"10.1177\/2473011420966311"},{"key":"e_1_2_7_47_1","doi-asserted-by":"publisher","DOI":"10.22203\/eCM.v015a05"},{"key":"e_1_2_7_48_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijom.2010.05.005"},{"key":"e_1_2_7_49_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejro.2020.100249"},{"key":"e_1_2_7_50_1","doi-asserted-by":"publisher","DOI":"10.2214\/ajr.97.3.708"}],"container-title":["Journal of Orthopaedic Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jor.25682","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,19]],"date-time":"2024-01-19T13:38:39Z","timestamp":1705671519000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jor.25682"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,29]]},"references-count":49,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1002\/jor.25682"],"URL":"https:\/\/doi.org\/10.1002\/jor.25682","archive":["Portico"],"relation":{},"ISSN":["0736-0266","1554-527X"],"issn-type":[{"value":"0736-0266","type":"print"},{"value":"1554-527X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,29]]},"assertion":[{"value":"2023-01-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-29","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}