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

由于世界人口老龄化，骨的替代、修复或再生技术已成为骨科、脊柱、牙科、颅外科和颌面外科等领域的主要临床需求。对于这些患有骨质流失和骨缺损的患者来说，手术治疗仍然是一个主要的挑战。传统的植骨技术存在供体部位病变、病毒传播、免疫不相容、康复时间长、结构失效等缺点。因此，迫切需要治疗骨缺损的新策略。理想的骨移植材料必须：(i)与健康骨的力学性能相匹配；（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的骨骼所取代。到目前为止，还没有一种合成材料能够同时满足这三个要求。在本项目中，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骨移植物。该材料的所有成分都是完全生物相容性的，并且fda批准用作生物材料。矿物质含量提供刚度，而较弱的蛋白质层可以偏转进入的裂缝，以产生韧性。这意味着这种材料可以用来制造承载接枝，而不是传统的太脆的磷酸钙/硫酸钙。结构骨移植物可以有不同的大小和尺寸。体内性能将在动物研究中进行评估。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物。这项新的医疗技术将对创伤、关节置换术失败、骨肿瘤、颌面手术或其他骨病患者继发结构性骨缺损的重建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 havebecome a major clinical need in the fields of orthopaedic, spinal, dental, cranial, andmaxillofacial surgery. For these patients that suffer from bone loss and bone defects, surgicaltreatment remains a major challenge. Traditional bone grafting techniques have performancelimitations including donor site morbidity, viral transmission, immunologic incompatibility, longrehabilitation time and structural failure. The need for new strategies for the treatment of bonedefects is therefore urgent. The ideal bone graft material must: (i) match the mechanicalproperties of healthy bone; (ii) be biocompatible and promote healing and (iii) must degradeover time to be replaced by healthy bone. To this day, there is no synthetic material that canfulfill these three requirements simultaneously. In this project we will develop a new structuralbone graft made from calcium sulfate, collagen and gelatin. All components of this materialare fully biocompatible and FDA-approved for use as biomaterials. The mineral contentprovides stiffness, while the weaker protein layers can deflect incoming cracks to generatetoughness. 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 structuralbone graft can be of varying sizes and dimensions. In-vivo performance will be evaluated withan animal study. In addition, bone grafts with complex patient-specific shapes will bedeveloped using 3D printed polymeric templates. This new medical technology will have asignificant impact on restoring functionality and quality of life in patients requiringreconstruction of structural bone defects secondary to trauma, failed arthroplasties, bonetumors, maxillofacial surgery or other bone diseases.