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

摘要 大多数骨折患者的骨密度无明显变化。通常，骨折的结果是 是毁灭性的，并导致大量的发病率和医疗保健费用。这些病人脆弱的一个原因是 骨质差，导致骨折风险增加。然而，很少有技术可用于 在临床上准确评估骨质量。双能X射线吸收法（DXA）是最常用的临床检查方法。 替代骨折风险，但DXA不能解释骨质量，因此高估了骨健康。 OsteoProbe®参考点压头能够测量人类患者的骨质， 已安全用于3,000多人。OsteoProbe®可量化骨材料质量， 称为骨材料强度指数（BMSi）在胫骨通过使用快速微压痕过程。一 胫骨BMSi与骨折发生之间存在显著且高度预测性的关系 多处骨骼部位BMSi也被证明可以强烈预测股骨的骨强度 脖子由于脆性骨折经常发生在髋关节、腕关节和脊柱，因此本研究将探讨 胫骨OsteoProbe测量值与这些临床相关骨骼部位的骨强度之间的关系， 绝经后的尸体我们假设胫骨OsteoProbe®测量值可预测骨强度 在整个骨骼和组织水平，在臀部，手腕，和脊柱。在每个骨骼部位，OsteoProbe 将进行骨密度测量、骨密度以及全骨和组织水平机械测试。该提案旨在 目的：（1）建立体内骨强度临床相关替代物的机制基础， 在髋关节、腕关节和脊柱处进行准确测量;（2）将OsteoProbe转换为最终的商业产品 针对目标商业环境中的可用性进行了优化的配置;以及（3）提供FDA批准 OsteoProbe是一种临床有用的器械，旨在解决骨质诊断差距。

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.