Evaluating and Improving and Emergent Technology for Fixation of Bone Fractures

描述(申请人提供)：在美国，每年有620万例四肢骨折患者接受治疗，花费超过130亿美元。即使在今天，5-8%的骨折在固定和愈合过程中也会出现并发症，这是一个重要的次要但可以预防的公共卫生问题。锁定钢板被认为是当今骨折固定最重要的进步之一。保留骨膜血供，可改善骨质疏松的固定。因此，它提供了一个巨大的机会来提高有问题的高能量骨折和骨质疏松性骨折的愈合率。通过为紧迫的临床挑战提供潜在的解决方案，锁定钢板技术得到了迅速和广泛的接受，尽管实际上缺乏支持数据。这种热情与最近关于锁定钢板的临床报告中发现的13%-21%的失败率形成了鲜明对比。这些临床并发症大多表现为延迟愈合或骨不连。这些并发症的可能原因是锁定钢板结构的高刚性，它可以抑制二次骨愈合所需的碎块间运动。与传统钢板不同，锁定钢板依靠骨痂形成进行二次骨愈合。为了解决锁定钢板固有的这个问题，我们探索了一种新的策略，称为远皮质锁定(FCL)，能够在保持足够的固定强度的同时降低锁定钢板结构的刚性。这项拟议的体内研究将首次调查锁定钢板如何影响绵羊骨折模型的骨折愈合。此外，我们还将测试减少僵硬的FCL固定是否能促进骨折愈合。具体目的1将比较保留骨膜的锁定钢板和传统钢板，以确定生物保存的锁定钢板是否可以促进骨折愈合。具体目标2将比较锁定钢板和FCL钢板，以确定减少僵硬的FCL结构是否可以促进骨折愈合。具体目标3将比较FCL电镀和标准传统电镀，以评估FCL电镀提供的生物保护和降低硬度的综合效益。这项拟议的探索性和发展性研究是在科学基础上评估和优化锁定电镀技术的紧迫的第一步。研究结果将对易于采用的锁定钢板技术进行早该进行的评估，从而具有直接的临床意义。此外，通过为与当代锁定钢板相关的固有问题提供工作解决方案，结果可能指导锁定钢板技术的未来发展。

DESCRIPTION (provided by applicant): Each year, 6.2 million extremity fractures are treated in the US at a cost in excess of $13 billion. Even today, 5-8% of these fractures experience complications in fixation and healing, which presents a significant secondary, but preventable, public health issue. Locked plating is thought to be one of the most important, present-day advancements in fracture fixation. It preserves periosteal blood supply and may improve fixation in osteoporotic bone. As such, it provides a tremendous opportunity to improve the healing rate in problematic high-energy fractures and osteoporotic fractures alike. By providing a potential solution to a pressing clinical challenge, locked plating technology has gained rapid and widespread acceptance despite the virtual absence of supportive data. This enthusiasm is in stark contrast to the 13-21% failure rates found in recent clinical reports on locked plates. The majority of these clinical complications manifest as delayed unions or non-unions. The likely reason for these complications is the high stiffness of locked plate constructs, which can suppress the interfragmentary motion required for secondary bone healing. Unlike conventional plates, locked plates rely on secondary bone healing by callus formation. As a solution to this problem inherent to locked plating, we have explored a novel strategy, termed Far Cortical Locking (FCL), capable of reducing the stiffness of locked plate constructs while retaining sufficient fixation strength. The proposed in vivo study will investigate for the first time, how locked plating affects fracture healing in an ovine fracture model. In addition, we will test if stiffness-reduced FCL fixation can enhance fracture healing. Specific Aim 1 will compare periosteum-sparing locked plating and conventional plating to determine if biology-preserving locked plates can improve fracture healing. Specific Aim 2 will compare locked plating and FCL plating to determine if stiffness-reduced FCL constructs can improve fracture healing. Specific Aim 3 will compare FCL plating to standard conventional plating to evaluate the combined benefit of biology-preservation and reduced stiffness provided by FCL plating. This proposed exploratory and developmental research constitutes an urgent first step toward evaluation and optimization of locked plating technology on a scientific basis. Results will have direct clinical implications by providing a long-overdue evaluation of readily adopted locked plating technology. Furthermore, results may direct the future evolution of locked plate technology by providing a working solution to an inherent problem associated with contemporary locked plates.