A New Device to measure Whole and Tissue Level Bone Strength.

摘要 大多数骨折患者具有非骨质疏松性骨密度。通常情况下，骨折的结果 这是毁灭性的，并导致相当大的发病率和医疗费用。这些患者脆弱的一个原因 骨骼质量差会导致更高的骨折风险。然而，几乎没有什么技术可以用来 在临床上准确评估骨质量。摘要双能x射线骨密度仪(Dxa)是临床上应用最广泛的一种骨密度仪。 骨折风险的替代者，但DXA不考虑骨骼质量，因此高估了骨骼健康。 OsteoProbe®参考点压痕仪能够测量人类患者的骨质量，并具有 已在3000多人身上安全使用。OsteoProbe®将骨材料质量量化为一种衡量标准 所谓的骨材料强度指数(BMSi)在胫骨通过使用快速微压入过程。一个 已证实胫骨BMSi与骨折发生之间存在显著的高度预测性关系 在多个骨骼部位。BMSI也被证明可以很好地预测股骨的骨强度 脖子。由于脆性骨折经常发生在髋关节、手腕和脊柱，本研究将探讨两者之间的关系。 在胫骨的骨探测量和这些临床相关骨骼部位的骨强度之间 绝经后的身体。我们假设胫骨OsteoProbe®测量将预测骨强度 在臀部、手腕和脊柱的整个骨骼和组织水平。在每个骨骼部位，OsteoProbe 将进行测量、骨密度以及整个骨骼和组织水平的机械测试。该提案旨在 目的：(1)建立临床相关的体内骨强度替代物的力学基础 精确测量臀部、手腕和脊椎；(2)将OsteoProbe过渡到最终的商业广告 针对目标商业环境中的可用性进行优化的配置；以及(3)提供FDA批准 OsteoProbe是一种临床有用的设备，旨在解决骨质量诊断方面的差距。

Abstract The majority of patients who fracture have non-osteoporotic bone mineral density. Often, the result of a fracture is devastating and results in substantial morbidity and health care costs. One cause of fragility in these patients is poor bone quality that subsequently contributes to higher risk for fracture. Yet few techniques are available to accurately assess bone quality in the clinic. Dual energy x-ray absorptiometry (DXA) is the most used clinical surrogate for fracture risk, but DXA does not account for bone quality and thus overestimates bone health. OsteoProbe® Reference Point Indenter enables the measurement of bone quality in human patients and has been used safely on over 3,000 individuals. The OsteoProbe® quantifies bone material quality as a measure termed bone material strength index (BMSi) at the tibia through the use of a rapid microindentation process. A significant and highly predictive relationship has been demonstrated between tibial BMSi and fracture occurrence at multiple skeletal sites. BMSi has also been shown to be strongly predictive of bone strength at the femoral neck. As fragility fractures often occur at the hip, wrist, and the spine, this study will investigate the relationship between OsteoProbe measurements at the tibia and bone strength at these clinically relevant skeletal sites on post-menopausal cadavers. We hypothesize that tibial OsteoProbe® measurements will predict bone strength at the whole bone and tissue levels at the hip, wrist, and spine. At each of these skeletal sites, OsteoProbe measurements, BMD, and whole bone and tissue level mechanical testing will be performed. The proposal aims to: (1) establish the mechanistic basis by which a clinically relevant surrogate of in vivo bone strength could be accurately measured at the hip, wrist, and spine; (2) transition OsteoProbe into the final commercial configuration optimized for usability in the target commercial environment; and (3) provide for an FDA approval of OsteoProbe as a clinically useful device aimed at addressing the bone quality diagnostic gap.