Development and evaluation of novel bone anchors and "smart" adaptive implants for the treatment of the bone deficient skeleton

由于骨折或骨组织损失导致的骨骼生物力学完整性的损失通常导致过早残疾，并使患者生活质量降低。骨骼疾病，如骨质疏松相关的骨折、溶骨性骨丢失和其他与创伤、骨肿瘤和手术切除相关的骨缺损，给卫生保健系统带来了巨大的经济负担。尽管在植入物设计、增强方法和再生医学方法方面做出了相当大的研究努力，骨缺损骨骼的外科治疗仍然具有挑战性，临床结果不令人满意。本提案中描述的研究目标是开发和评估新型植入物，i）增强骨螺钉在低质量骨中的固定，ii）“智能”自适应植入物，确保愈合骨的适当载荷，以确保骨折修复和骨再生的最佳生物力学环境。将开发和评估一种基于可膨胀螺旋的新型骨螺钉锚，用于骨科手术中螺钉固定的不同区域。螺旋件具有与骨螺钉匹配的螺距和内径，使得骨螺钉可以像螺栓拧入螺母那样拧入螺旋件中。此外，还将开发新型“智能”自适应植入物，通过结合可吸收生物材料和金属植入物材料，优化植入物之间的载荷分配。植入物概念将使用有限元模型开发，其有效性和安全性将在人体和动物模型中进行评估。总之，拟议的研究将产生新的创新外科植入物，这将大大提高骨折治疗和骨再生的成功率。这些新型植入物将被整合到多学科治疗策略中，以实现有效管理，并将促进现有的跨学科合作，揭示治疗骨缺损骨骼的新机会，并最终提高患者的生活质量，减少这些疾病对社会的社会和经济负担。

Loss of the biomechanical integrity of the skeleton due to fracture or loss of bone tissue often leads to premature disability and leaves the patient with a reduced quality of life. The economic burden on the health care system of skeletal conditions such as osteoporosis-related fractures, osteolytic bone loss and other bone defects related to trauma, bone tumors and surgical resections is enormous. Despite considerable research efforts in implant design, augmentation methods and regenerative medicine approaches, the surgical treatment of the bone deficient skeleton remains challenging with unsatisfactionary clinical outcomes.The goal of the research described in this proposal is to develop and evaluate novel implants that i) enhance the fixation of bone screws in low quality bone and ii)"smart" adaptive implants that ensure appropriate loading of healing bone to ensure an optimal biomechanical environment for fracture repair and bone regeneration.A novel bone screw anchor based on an expandable helix, will be developed and evaluated for different areas of screw fixation in orthopaedic surgery. The helix has a matched pitch and inner diameter to the bone screw such that the bone screw can be screwed into the helix like a bolt into a nut. In addition, novel "smart" adaptive implants will be developed to optimize the load sharing between implants by combining absorbable biomaterials and metallic implant materials. Implant concepts will be developed using finite element, models and their efficacy and safety will be evaluated in human cadeveric and animal models.In summary, the proposed research will result in new innovative surgical implants that will substantially increase the success rate of fracture treatment and bone regeneration. These novel implants will be integrated into a multidisciplinary treatment strategy for an effective management and also will foster exiting interdisciplinary collaboration that reveal new opportunities to treat the bone deficient skeleton and ultimately enhance the quality of live of patients and reduce the social and economic burden of these diseases on society.