Advanced Plate Osteosynthesis Technology to Promote Healing of Bone Fractures

描述(由申请人提供)：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%经历了并发症，特别是在稳步增长的骨质疏松人群中。锁定钢板技术通过在骨质疏松的骨质中提供更好的固定，迅速改变了使用钢板治疗骨折的方式。在过去的十年里，锁定钢板占据了11亿美元的美国钢板市场的88%，尽管几乎没有临床数据支持结果的改善。然而，最近关于锁定钢板的临床研究报告的失败率为13%-21%，冲淡了这波热情。研究证实，锁定钢板的骨折愈合不足很大程度上是由于其固有的刚性，这抑制了通过骨痂形成刺激骨愈合所需的碎块间运动。拟议的研究将评估创新的锁定电镀战略的可行性，旨在解决目前锁定电镀技术日益增长的不结合问题。我们建议的产品是一种弹性锁定钢板(E-Lock钢板)，带有灵活悬挂的螺丝孔，允许在骨折部位进行受控运动，通过骨痂形成积极促进骨折愈合。这项可行性研究将检验这一假设，即E-Lock钢板可以在已知的促进骨折愈合的范围内提供可控制的碎块间运动，同时提供与标准锁定钢板结构相当的固定强度。为此，初步的E-Lock钢板设计将经过计算优化，以提供所需的刚度和碎片间运动，以促进骨痂形成，同时最大限度地提高结构强度。优化后的解决方案将转化为功能原型E-Lock板，用于台式测试。E-Lock钢板结构将在所有主要加载模式下与标准锁定钢板结构进行直接比较测试。这项研究的结果对于将这项有前景的技术转化为先进的骨折治疗，特别是对老年人口中的骨质疏松性骨折的治疗至关重要。这项研究的成功完成将决定E-Lock技术在保持锁定钢板改进的固定强度的同时，积极促进骨折愈合的可行性。这项技术还将通过降低每年仅在美国就接受锁定钢板治疗的20多万名患者中与标准锁定钢板相关的惊人不愈合率来预防骨不连。 公共卫生相关性：通过提供出色的骨折稳定性，锁定钢板技术已在88%的接骨板中应用，但最近的研究表明，这些锁定钢板太僵硬，抑制了骨折愈合，大约五分之一的患者需要翻修手术。这项拟议的研究评估了一种创新设计的可行性，这种设计可以使锁定钢板不那么僵硬，并可以积极促进骨折愈合。如果这项新技术能够成功地转化为商业解决方案，它将减少每年在美国使用锁定钢板治疗的20多万名患者因骨折愈合不足而造成的惊人成本和社会负担。

DESCRIPTION (provided by applicant): 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 has rapidly transformed fracture treatment with bone plates. Over the past decade, locked plating captured 88% of the $1.1 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 recent 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. The proposed research will assess the feasibility of an innovative locked plating strategy aimed at resolving the growing concern of non-unions with current locked plating technology. Our proposed product is an elastic locking plate (E-Lock plate) with flexibly suspended screw holes that permit controlled motion at the fracture site to actively promote fracture healing by callus formation. This feasibility study will test the hypothesis that E-Lock plates can deliver controlle interfragmentary motion within the range known to promote fracture healing, while providing fixation strength comparable to that of a standard locked plating construct. For this purpose, the preliminary E-Lock plate design will be computationally optimized to deliver the required stiffness and interfragmentary motion for promotion of callus formation, while maximizing construct strength. The optimized solution will be translated into functional prototype E-Lock plates for bench-top testing. E-Lock plating constructs will be tested in direct comparison to standard locked plating constructs in all principal loading modes. Results of this research will be essential to translate this promising technology into an advanced fracture treatment, particularly for treatment of osteoporotic fractures in the elderly population. Successful completion of this research will determine the feasibility of E-Lock technology to actively promote fracture healing while retaining the improved fixation strength of locking plates. This technology will furthermore be poised to prevent non-unions by reducing the staggering non-union rate associated with standard locking plates in the over 200,000 patients that are treated each year with locking plates in the United States alone. PUBLIC HEALTH RELEVANCE: By providing superior stabilization of bone fractures, locking plate technology has been implemented in 88% of all bone plates, but recent studies indicate that these locking plates are too stiff and suppress fracture healing, requiring revision surgery i approximately one out of five patients. The proposed research evaluates the feasibility of an innovative design that makes locking plates less stiff and that can actively promote fracture healing. If this novel technology can be successfully transferred into a commercial solution, it will reduce the staggering cost and societal burden caused by deficient fracture healing in over 200,000 patients that are treated each year in the USA with locking plates.