Improving Fracture Healing with Active Plating Technology

在美国，每年有600多万人接受骨折治疗，费用超过 130亿美元。这些骨折中有5%-8%会出现并发症，特别是在 患有骨质疏松症的人口稳步增加。通过为骨质疏松患者提供更好的固定 锁定接骨板技术迅速改变了接骨板治疗骨折的方式。已锁定 电镀已经占据了美国19亿美元电镀市场的83%，尽管实际上没有 临床数据支持结果的改善。然而，热情的浪潮一直是 在锁定钢板的临床研究中报告的失败率为13%-21%。研究表明， 证实使用锁定钢板观察到的骨折愈合不足主要是由于其 固有的僵硬，抑制了刺激骨骼愈合所需的碎片间运动 通过愈伤组织的形成。 广泛的初步研究提供了确凿的证据，证明一种创新的电镀 概念，称为活性镀，保留了锁定钢板和 提供可控的碎块间运动，以促进骨折愈合。活性电镀 通过弹性悬挂板2内的螺纹孔来提供受控的碎片间运动。 这种活性镀液已被证明能够刺激骨折的自然愈合，显著地 与标准锁定钢板相比，愈合更快、更坚固、更稳定。建议的阶段 II研究和开发工作将支持将主动电镀技术转化为 临床产品通过完成两个目标：第一，将先进的主动电镀设计 植入股骨远端钢板系统。第二，将进行体内研究，以 量化骨折愈合的强度、速度、对称性和一致性方面的改进 由活性电镀提供，与标准锁定电镀相比。 完成这两个目标将提供两个截然不同的交付成果：Active的翻译 将电镀技术转化为商业上可行的植入物溶液；以及在 活体记录其对骨折愈合的影响。由于主动电镀技术是可扩展的，我们的 愿景是将技术扩展到广泛的电镀解决方案，并引发一种范式 转向骨折固定，利用生物骨折愈合的潜力 轴向柔性植入物解决方案。鉴于已证实的受控碎片间的潜力 加速和放大骨折愈合级联的运动，成功完成 拟议的研究和开发将带来更快、更强的愈合的好处 并减轻非工会造成的巨大经济和社会负担。

Each year, over 6 million fractures are treated in the United States at a cost in excess of $13 billion. Between 5-8% of these fractures experience complications, particularly in the steadily increasing population with osteoporosis. By providing better fixation in osteoporotic bone, locked plating technology rapidly transformed fracture treatment with bone plates. Locked plating has captured 83% of the $1.9 billion US plating market, despite the virtual absence of clinical data supporting improvements in outcome. However, the wave of enthusiasm has been tempered by failure rates of 13-21% reported in clinical studies on locked plating. Research has confirmed that deficient fracture healing observed with locking plates is largely due to their inherent stiffness, which suppresses interfragmentary motion required to stimulate bone healing by callus formation. Extensive preliminary studies delivered conclusive proof that an innovative plating concept, termed Active Plating, retains the superior fixation strength of locking plates and delivers controlled interfragmentary motion known to promote fracture healing. Active Plating provides controlled interfragmentary motion by elastic suspension of screw holes inside a plate 2. This Active Plating solution has shown to stimulate natural fracture healing, yielding significantly faster, stronger, and more consistent healing than standard locking plates. The proposed Phase II research and development efforts will support translation of Active Plating technology into a clinical product by completion of two aims: First, an advanced Active Plating design will be implemented into a distal femur plate system. Second, an in vivo study will be conduct to quantify improvements in the strength, speed, symmetry, and consistency of fracture healing provided by Active Plating in comparison to standard locked plating. Completion of the two aims will provide two distinct deliverables: translation of Active Plating technology into a commercially viable implant solution; and a performance evaluation in vivo to document its effects on fracture healing. Since Active Plating technology is scalable, our vision is to expand the technology to a wide range of plating solutions, and to trigger a paradigm shift towards fracture fixation that harnesses the potential of biologic fracture healing induced by axially flexible implant solutions. Given the proven potential of controlled interfragmentary motion to accelerate and amplify the fracture healing cascade, successful completion of the proposed research and development is poised to deliver the benefits of faster, stronger healing to patients, and to decrease the substantial economic and societal burden of non-unions.