Novel multilayered synthetic structural bone graft materials which combine biocompatibility, biodegradability and high toughness

由于世界人口老龄化，骨替换、修复或再生技术已成为骨科、脊柱、牙科、颅骨和颌面外科领域的主要临床需求。对于这些患有骨丢失和骨缺损的患者，手术治疗仍然是一个重大挑战。传统的骨移植技术存在性能局限性，包括供区发病率、病毒传播、免疫不相容性、长的康复时间和结构失效。因此，迫切需要新的策略来治疗骨缺损。理想的骨移植材料必须：（i）匹配健康骨的机械 ** 特性;（ii）具有生物相容性并促进愈合;（iii）必须随时间降解 ** 以被健康骨取代。直到今天，还没有合成材料可以 ** 同时满足这三个要求。在这个项目中，我们将开发一种由硫酸钙、胶原蛋白和明胶制成的新型结构性骨移植物。该材料的所有成分 ** 均具有完全生物相容性，并经FDA批准可用作生物材料。矿物质成分提供了硬度，而较弱的蛋白质层可以使进入的裂缝偏转，从而产生韧性。这意味着这种材料可用于制造承重移植物，** 而不是传统的磷酸钙/硫酸钙，它们太脆。结构性骨移植物可以具有不同的大小和尺寸。将通过 ** 动物研究评价体内性能。此外，将使用3D打印聚合物模板开发具有复杂患者特定形状的骨移植物。这项新的医疗技术将对因创伤、失败的关节成形术、骨肿瘤、颌面外科手术或其他骨骼疾病而需要重建结构性骨缺损的患者恢复功能和生活质量产生重大影响。

Due to the ageing world population, techniques to replace, restore, or regenerate bone have**become a major clinical need in the fields of orthopaedic, spinal, dental, cranial, and**maxillofacial surgery. For these patients that suffer from bone loss and bone defects, surgical**treatment remains a major challenge. Traditional bone grafting techniques have performance**limitations including donor site morbidity, viral transmission, immunologic incompatibility, long**rehabilitation time and structural failure. The need for new strategies for the treatment of bone**defects is therefore urgent. The ideal bone graft material must: (i) match the mechanical**properties of healthy bone; (ii) be biocompatible and promote healing and (iii) must degrade**over time to be replaced by healthy bone. To this day, there is no synthetic material that can**fulfill these three requirements simultaneously. In this project we will develop a new structural**bone graft made from calcium sulfate, collagen and gelatin. All components of this material**are fully biocompatible and FDA-approved for use as biomaterials. The mineral content**provides stiffness, while the weaker protein layers can deflect incoming cracks to generate**toughness. The implication is that this material can be used to fabricate load-carrying grafts,**as opposed to traditional calcium phosphates/sulfates which are too brittle. The structural**bone graft can be of varying sizes and dimensions. In-vivo performance will be evaluated with**an animal study. In addition, bone grafts with complex patient-specific shapes will be**developed using 3D printed polymeric templates. This new medical technology will have a**significant impact on restoring functionality and quality of life in patients requiring**reconstruction of structural bone defects secondary to trauma, failed arthroplasties, bone**tumors, maxillofacial surgery or other bone diseases.