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TricOs~(TM) and Fibrin Sealant Combined for Bone Defect Filling: From Pre-Clinical Tests to Prospective Clinical Study. Preliminary human data

机译：TricOsTM和纤维蛋白封闭剂联合用于骨缺损的填充：从临床前测试到预期的临床研究。初步人类数据

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The association of TricOs~(TM) (Macroporous Biphasic Ceramic Phosphate MBCP granules) and the fibrin sealant FS VH S/D 4, has been developed to answer a challenging request of orthopaedic surgeons: a biocompatible, osteogenic, mouldable, and self-hardening bone substitute able to fill randomly shaped bone defects. The aims of this study was the evaluation of the performance and safety of the bioactive bone substitute TricOs~(TM) associated with a fibrin sealant in regeneration of functional bone. The pre-clinical tests were conducted to optimize MBCP granules size and ratio MBCP-FS VH S/D 4 (sheep maxillary sinus grafting, femoral epiphysis defect in rabbits, long bone defects in sheep). A clinical study design was set up as an exploratory prospective French multicentric phase II study sponsored by INSERM (Institut National de la Sante et de la Recherche Medicale). The application was the TOV (Tibial Osteotomy of Valgisation) using osteosynthesis and bone substitute: TricOs~(TM) mixed with the fibrin sealant (FS VH S/D 4) for filling the space created. The follow up is 13 months with safety checks, clinical assessments, high-sensitivity X-ray, and CT-scan imaging. A bone sample will be collected from the reconstructed area at 12 months, during the osteosynthesis material removal surgery. The principal criterion is CT-scan imaging performed 12 months after TOV surgery, before material removal, to assess qualitative and quantitative bone reconstruction. Animals' studies demonstrate that the biomaterial is safe to use and shows osteoconductive properties, granules resorption and bone ingrowth at the expenses of the implants. As for clinical trial, 7 patients are today included in the study: This paper present the first results obtained from X-ray imaging during follow up.
机译：TricOs〜（TM）（多孔双相陶瓷磷酸盐MBCP颗粒）与纤维蛋白密封剂FS VH S / D 4的结合已得到开发，可满足骨科医生的挑战性要求：具有生物相容性，成骨性，可塑性和自硬化性骨替代物能够填充随机形状的骨缺损。这项研究的目的是评估功能性骨再生中与纤维蛋白封闭剂相关的生物活性骨替代品TricOsTM的性能和安全性。进行临床前测试以优化MBCP颗粒的大小和比例MBCP-FS VH S / D 4（绵羊上颌窦移植，兔股骨epi缺损，绵羊长骨缺损）。一项临床研究设计是由INSERM（国家圣德拉等人医学研究所）赞助的一项探索性法国多中心II期探索性前瞻性研究。应用是使用骨合成和骨替代物：TricOsTM与纤维蛋白密封剂（FS VH S / D 4）混合的TOV（Valgisation胫骨截骨术），以填充所创造的空间。随访时间为13个月，包括安全检查，临床评估，高灵敏度X射线和CT扫描成像。在接骨材料去除手术期间，将在12个月时从重建区域收集骨样品。主要标准是在TOV手术后12个月进行CT扫描成像，然后去除材料，以评估骨重建的定性和定量。动物研究表明，这种生物材料使用安全，并具有骨传导性能，颗粒吸收和骨向内生长的特性，但以植入物为代价。至于临床试验，今天有7名患者包括在研究中：本文介绍了在随访期间从X射线成像获得的第一批结果。

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