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Advanced Plate Osteosynthesis Technology to Promote Healing of Bone Fractures

先进的钢板接骨技术促进骨折愈合

基本信息

批准号：
8252796
负责人：
MICHAEL BOTTLANG
金额：
$ 14.84万
依托单位：
APEX BIOMEDICAL COMPANY, LLC
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-06-01 至 2013-05-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：每年，在美国治疗超过600万例骨折，费用超过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患者中。锁定接骨板技术通过在骨质疏松骨中提供更好的固定，迅速改变了接骨板的骨折治疗。在过去的十年里，尽管几乎缺乏支持结果改善的临床数据，但锁定接骨板占据了美国11亿美元接骨板市场的88%。然而，最近关于锁定钢板的临床研究报告的失败率为13-21%，这一热情的浪潮已经被冲淡了。研究证实，锁定接骨板观察到的骨折愈合不足主要是由于其固有刚度，这抑制了骨痂形成刺激骨愈合所需的骨折块间运动。拟议的研究将评估一种创新的锁定接骨板策略的可行性，旨在解决目前锁定接骨板技术引起的骨不连问题。我们的申报产品是一种弹性锁定接骨板（E-Lock接骨板），带有柔性悬挂螺钉孔，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。本可行性研究将检验E-Lock接骨板能够在已知范围内提供可控骨折块间活动以促进骨折愈合，同时提供与标准锁定接骨板结构相当的固定强度的假设。为此，将对初步E-Lock接骨板设计进行计算优化，以提供所需的刚度和骨折块间运动，促进骨痂形成，同时最大限度地提高结构强度。优化的解决方案将转化为功能原型E-Lock接骨板，用于实验室测试。将在所有主要载荷模式下对E-Lock接骨板结构进行测试，并与标准锁定接骨板结构进行直接比较。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，特别是治疗老年人的骨质疏松性骨折至关重要。本研究的成功完成将确定E-Lock技术在积极促进骨折愈合的同时保持锁定钢板固定强度提高的可行性。这项技术将进一步准备通过降低与标准锁定钢板相关的惊人的不愈合率来预防骨不连，仅在美国每年就有超过20万名患者接受锁定钢板治疗。公共卫生相关性：通过提供骨折的上级稳定性，锁定板技术已在88%的所有接骨板中实施，但最近的研究表明，这些锁定板太硬并抑制骨折愈合，大约五分之一的患者需要翻修手术。这项研究评估了一种创新设计的可行性，这种设计使锁定钢板的刚度降低，并能积极促进骨折愈合。如果这项新技术能够成功地转化为商业解决方案，它将减少美国每年超过20万名使用锁定钢板治疗的患者因骨折愈合不良而造成的惊人成本和社会负担。