Improving Fracture Healing with Active Plating Technology

利用活性镀技术改善骨折愈合

• 批准号: 10249794
• 负责人: MICHAEL BOTTLANG
• 金额: $ 45.55万
• 依托单位: APEX BIOMEDICAL COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249794
• 关键词: Adult; Biological; Bone callus; Bone plates; Clinical; Clinical Data; Clinical Research; Cost efficiency; Custom; Development; Distal; Economics; Evaluation; Failure; Femur; Fracture; Fracture Fixation; Fracture Healing; Funding; Generations; Implant; Incidence; Limb structure; Mechanics; Modeling; Motion; Operative Surgical Procedures; Osteoporosis; Outcome; Patients; Performance; Phase; Population; Reporting; Research; Sheep; Speed; Suspensions; System; Technology; Testing; Time; Translating; Translations; United States; Vision; base; bone healing; cost; design; experience; flexibility; healing; improved; improved functioning; in vivo; in vivo evaluation; innovation; instrumentation; manufacturability; osteoporotic bone; prevent; research and development; sample fixation; tibia; virtual

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.

每年，在美国治疗超过600万例骨折， 130亿美元这些骨折中有5-8%发生并发症，特别是在 骨质疏松症的患病人数不断增加。通过提供更好的固定， 锁定接骨板技术迅速改变了接骨板的骨折治疗。锁定 电镀已经占据了19亿美元美国电镀市场的83%，尽管实际上没有 支持结局改善的临床数据。然而，热情的浪潮已经被 锁定接骨板临床研究报告的失败率为13-21%。研究 证实锁定钢板观察到的骨折愈合不足主要是由于 固有刚度，抑制刺激骨愈合所需的骨折块间运动 通过愈伤组织的形成。 广泛的初步研究提供了确凿的证据， 被称为“主动接骨板”的概念保留了锁定接骨板的上级固定强度，并 提供已知的促进骨折愈合的可控骨折块间运动。活性电镀 通过板2内的螺孔的弹性悬挂提供受控的碎片间运动。 这种活性电镀解决方案已被证明可以刺激自然骨折愈合， 与标准锁定接骨板相比，愈合更快、更牢固、更一致。拟议阶段 II研究和开发工作将支持将活性电镀技术转化为 临床产品通过完成两个目标：首先，先进的主动电镀设计将是 实施到远端股骨板系统中。其次，将进行体内研究， 量化骨折愈合的强度、速度、对称性和一致性的改善 与标准锁定接骨板相比，由主动接骨板提供。 这两个目标的完成将提供两个不同的可交付成果： 将电镀技术应用于商业上可行的植入物溶液中; 体内试验，以记录其对骨折愈合的影响。由于活性电镀技术是可扩展的，我们的 我们的愿景是将该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。考虑到可控的碎片间 运动，以加速和放大骨折愈合级联，成功完成 拟议的研究和开发准备提供更快，更强的愈合的好处， 并减少骨不连造成的巨大经济和社会负担。