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

一种测量整体和组织水平骨强度的新设备。

• 批准号: 10656708
• 负责人: Peter Burks
• 金额: $ 5万
• 依托单位: ACTIVE LIFE SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10656708
• 关键词: Accreditation; Address; Adoption; American; Authorization documentation; Behavior; Biocompatible Materials; Biophysics; Bone Density; Bone Diseases; Bone Tissue; Cadaver; Clinic; Clinical; Clinical Research; Data; Development; Devices; Diagnostic; Disease; Distal; Dual-Energy X-Ray Absorptiometry; Endocrinologist; Environment; European; Foundations; Fracture; Glues; Health Care Costs; Hip region structure; Hospitals; Human; Incidence; Individual; International; Investigation; Investments; Label; Life Style; Location; Measurement; Measures; Mechanics; Medical center; Metabolic Bone Diseases; Metabolism; Methods; Minerals; Modeling; Monitor; Morbidity - disease rate; Nature; Neck; Pain; Patients; Peer Review; Phase; Physicians; Play; Population; Postmenopause; Predictive Value; Privatization; Procedures; Process; Professional Organizations; Proteins; Publications; Publishing; Radiation; Radiation exposure; Regulatory Pathway; Research; Resolution; Risk; Role; Sensory; Series; Site; Societies; Sterility; System; Techniques; Technology; Testing; Tissues; United States; United States Food and Drug Administration; Validation; Vertebral column; Vulnerable Populations; Woman; Work; Wrist; base; bone; bone health; bone loss; bone quality; bone strength; clinically relevant; fracture risk; fragility fracture; graphical user interface; handheld equipment; high risk; improved; in vivo; indexing; instrumentation; mechanical properties; medical specialties; nano; portability; radius bone structure; research and development; sensor; skeletal; spine bone structure; tibia; usability

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.

抽象的 大多数骨折患者的骨密度通常是非骨质疏松性的，这是骨折的结果。 是毁灭性的，导致大量的发病率和医疗费用，是这些患者脆弱的原因之一。 骨质量差会导致骨折风险增加，但目前几乎没有技术可以解决这一问题。 双能 X 射线吸收测定法 (DXA) 是临床上最常用的准确评估骨质量的方法。 DXA 可以替代骨折风险，但 DXA 不考虑骨骼质量，因此高估了骨骼健康状况。 OsteoProbe® 参考点压头能够测量人类患者的骨质量，并具有 OsteoProbe® 已被安全用于 3,000 多人，可量化骨材料质量。 通过使用快速微压痕过程测定胫骨的骨材料强度指数 (BMSi)。 胫骨 BMSi 与骨折发生之间已证明具有显着且高度预测的关系 BMSi 也被证明可以强烈预测股骨的骨强度。 由于脆性骨折经常发生在髋部、腕部和脊柱，本研究将探讨两者之间的关系。 胫骨处的 OsteoProbe 测量值与这些临床相关骨骼部位的骨强度之间的关系 我们勇敢地说，胫骨 OsteoProbe® 测量将预测骨强度。 在髋部、腕部和脊柱的整个骨骼和组织水平上，OsteoProbe 可以在每个骨骼部位进行检测。 该提案的目的是进行测量、骨密度以及整个骨骼和组织水平的机械测试。 目的：（1）建立机制基础，通过该基础可以确定体内骨强度的临床相关替代物 (2) 将OsteoProbe转变为最终的商业广告 针对目标商业环境中的可用性进行优化的配置；以及 (3) 获得 FDA 批准 OsteoProbe 作为一种临床上有用的设备，旨在解决骨质量诊断差距。

项目成果

Assessment of bovine cortical bone fracture behavior using impact microindentation as a surrogate of fracture toughness.

使用冲击微压痕作为断裂韧性的替代物来评估牛皮质骨骨折行为。

• DOI: 10.1101/2023.08.07.552351
• 发表时间: 2023
• 期刊: bioRxiv : the preprint server for biology
• 作者: Jahani,Babak;Vaidya,Rachana;Jin,JamesM;Aboytes,DonaldA;Broz,KaitlynS;Khrotapalli,Siva;Pujari,Bhanuteja;Baig,WaleeM;Tang,SimonY
• 通讯作者: Tang,SimonY