Advanced Plate Osteosynthesis Technology to Promote Healing of Bone Fractures

描述（由申请人提供）：在美国，每年有超过600万例骨折的治疗费用超过130亿美元。5-8%的骨折会出现并发症，尤其是在骨质疏松症患者中。锁定钢板技术为骨质疏松的骨提供了更好的固定，迅速改变了骨钢板治疗骨折的方式。在过去的十年中，锁定镀占据了美国11亿美元镀市场的88%，尽管实际上缺乏临床数据支持结果的改善。然而，在最近的临床研究中，锁定钢板的失败率为13-21%，这使得人们的热情有所减弱。研究证实，锁定钢板观察到的骨折愈合不足主要是由于其固有的刚度，这抑制了骨痂形成刺激骨愈合所需的碎片间运动。拟议的研究将评估一种创新的锁定镀策略的可行性，该策略旨在解决当前锁定镀技术对骨不连日益增长的担忧。我们提出的产品是一种弹性锁定钢板（E-Lock钢板），它具有灵活的悬浮螺钉孔，可以在骨折部位控制运动，通过骨痂形成积极促进骨折愈合。这项可行性研究将验证E-Lock钢板可以在已知范围内提供可控制的碎片间运动以促进骨折愈合的假设，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钢板设计将进行计算优化，以提供促进骨痂形成所需的刚度和碎片间运动，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电镀结构将在所有主要加载模式下与标准锁定电镀结构直接比较进行测试。这项研究的结果对于将这项有前途的技术转化为先进的骨折治疗，特别是治疗老年人骨质疏松性骨折至关重要。本研究的成功完成将确定E-Lock技术在保持锁定钢板提高的固定强度的同时，积极促进骨折愈合的可行性。仅在美国，每年就有超过20万的患者接受锁定钢板治疗，这项技术将进一步减少与标准锁定钢板相关的惊人的不愈合率，从而预防骨不连。

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.