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

由于世界人口老龄化，在骨科、脊柱、牙科、颅骨和颌面外科领域，替换、修复或再生骨的技术**已成为主要的临床需求。对于这些遭受骨丢失和骨缺损症折磨的患者来说，手术治疗仍然是一个重大挑战。传统的植骨技术具有性能**局限性，包括供体部位发病率、病毒传播、免疫不相容、康复时间长和结构故障。因此，迫切需要治疗骨**缺陷的新策略。理想的骨移植材料必须：(I)符合健康骨的机械性能；(Ii)具有生物相容性并促进愈合；(Iii)随着时间的推移，必须降解**才能被健康骨取代。直到今天，还没有一种合成材料能够**同时满足这三个要求。在这个项目中，我们将开发一种新的结构性**骨移植，由硫酸钙、胶原和明胶制成。这种材料的所有成分**都是完全生物兼容的，并经FDA批准用作生物材料。矿物质含量**提供硬度，而较弱的蛋白质层可以偏转进入的裂缝，产生**韧性。这意味着这种材料可以用来制造承载移植物，**而不是传统的磷酸钙/硫酸盐太脆。结构性的骨移植可以有不同的大小和尺寸。在体内的表现将通过**动物研究进行评估。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。这项新的医疗技术将对需要**重建因创伤、关节成形术失败、骨**肿瘤、颌面部手术或其他骨骼疾病而继发的结构性骨缺陷的患者的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.