{"title":"Platelet-Rich Fibrin Induces New Bone Formation to Promote Extreme Lateral Interbody Fusion of Spine in Rabbits.","authors":"Weijian Wang, Jiaqi Li, Han Wu, Sidong Yang, Shaorong Li, Wei Zhang","doi":"10.1002/jsp2.70179","DOIUrl":"10.1002/jsp2.70179","url":null,"abstract":"<p><strong>Background: </strong>Achieving rapid bone fusion is critical for preventing complications in Extreme Lateral Interbody Fusion (XLIF), yet harvesting sufficient autologous bone presents surgical limitations. Platelet-rich fibrin (PRF), an autologous biomaterial rich in osteogenic growth factors, offers potential as a bone graft enhancer. This study evaluated the efficacy of PRF combined with allogeneic bone in promoting interbody fusion using an XLIF-simulated rabbit model.</p><p><strong>Methods: </strong>In vitro, bone marrow mesenchymal stem cells were cultured with PRF, allogeneic bone, or PRF/allogeneic bone composites. Assessments included biocompatibility (CCK-8, Calcein-AM/PI), cell adhesion (phalloidin/DAPI), and osteogenic differentiation (alkaline phosphatase activity/staining, Alizarin Red S). PRF, allogeneic bone, and their composite (PRF/allogeneic bone) were evaluated in a rabbit XLIF model. Autologous iliac crest bone served as a positive control, while empty cages provided negative controls. Endpoints included radiographic (micro-CT), mechanical (biomechanical testing), histological (H&E, methylene blue-acid fuchsin, TRAP), and biochemical (ELISA) evaluation at postoperative 2, 4, 8, and 12 weeks.</p><p><strong>Results: </strong>In vitro experiments demonstrated that PRF/allogeneic bone composites exhibited noncytotoxic properties and osteogenic-promoting effects when combined with titanium alloy cages. In vivo, fusion progressed temporally across all groups, with the PRF/allogeneic bone composite yielding 12-week fusion rates by manual palpation and micro-CT equivalent to autograft. Biomechanical strength and bone mineral density of PRF/allogeneic bone matched autograft, exceeding allogeneic bone. Histology demonstrated accelerated fusion kinetics: early angiogenesis (2 weeks), fibrocartilage formation (4 weeks), and complete trabecular bridging by 12 weeks. ELISA confirmed earlier BMP-2/VEGF peaks (2-4 weeks) versus allogeneic bone.</p><p><strong>Conclusions: </strong>These results indicated that the combination of PRF and allogeneic bone successfully induced intervertebral bone formation in the rabbit XLIF model. PRF can serve as a physiological natural fusion material, inducing osteogenesis and achieving spinal fusion. Its osteopromotive effects, cost-effectiveness, and autologous origin support its potential as a superior graft alternative for XLIF procedures.</p>","PeriodicalId":14876,"journal":{"name":"JOR Spine","volume":"9 2","pages":"e70179"},"PeriodicalIF":3.9,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13081695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147698780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JOR SpinePub Date : 2026-04-14DOI: 10.1002/jsp2.70176
Amit Benady, Jerrin Thadathil Varghese, Ryan David Quarrington, Morsi Khashan, B. Gangadhara Prusty, Ashish Diwan
{"title":"From Concept to Clinic: Pre-Clinical Testing and Regulatory Considerations in Spine Implant Development","authors":"Amit Benady, Jerrin Thadathil Varghese, Ryan David Quarrington, Morsi Khashan, B. Gangadhara Prusty, Ashish Diwan","doi":"10.1002/jsp2.70176","DOIUrl":"https://doi.org/10.1002/jsp2.70176","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Spinal implant development demands integration of biomechanical rigor with regulatory compliance. For surgeons, researchers, and biomedical engineers engaged in translational research, understanding the regulatory pathway, from the <i>Design History File</i> (DHF) through post-market surveillance, is essential to smoothly transform an innovative idea into a safe and effective clinical product.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This paper reviews the major regulatory frameworks governing spinal implants, including the <i>United States Food and Drug Administration</i> (FDA) pathways such as <i>Premarket Notification</i> [510(k)] and <i>Premarket Approval</i> (PMA), as well as the <i>European Union Medical Device Regulation</i> (EU MDR) leading to <i>Conformité Européenne</i> (CE) marking. International standards such as ISO 13485 for quality systems, ISO 14971 for risk management, ISO 10993 for biocompatibility, and ASTM mechanical testing standards are discussed. Particular attention is given to how biomechanics, including <i>Finite Element Analysis</i> (FEA), bench testing, and fatigue studies, are integrated into the pre-market submission dossier.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Key elements of the regulatory process include design controls and documentation (DHF/technical file), <i>Chemistry, Manufacturing, and Controls</i> (CMC), preclinical validation through simulation, bench, cadaver, and animal testing, regulatory submissions across FDA and EU systems, and post-market surveillance and lifecycle management. Common pitfalls involve overreliance on simulations without validation, inadequate risk management, and insufficient traceability. Emerging trends such as <i>in silico</i> trials, digital twins, and smart implants show promise, while global differences in classification, clinical requirements, and post-market expectations highlight the ongoing challenge of regulatory divergence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Understanding the biomechanical foundations of the development process is crucial for the safe and successful translation of spine implants into clinical use. Surgeons and implant designers should engage early, understand the critical steps, and advocate for rigorous validation aligned with regulatory expectations to deliver safer and more effective implants to clinical practice.</p>\u0000 </section>\u0000 </div>","PeriodicalId":14876,"journal":{"name":"JOR Spine","volume":"9 2","pages":""},"PeriodicalIF":3.9,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jsp2.70176","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147668589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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