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矿物质密度非遗传性骨矿物质密度。通常，骨折的结果 是毁灭性的，导致了大量发病率和医疗保健成本。这些患者脆弱的原因之一 骨质质量很差，随后导致骨折风险更高。但是很少有技术可用于 准确评估诊所的骨质质量。双能X射线绝对肽（DXA）是最常用的临床 替代骨折风险，但DXA不能解释骨骼质量，从而高估了骨骼健康。 Osteoprobe®参考点缩进器可以测量人类患者的骨骼质量，并具有 安全地用于3,000多人。 Osteoprobe®量化骨料质量作为量度 通过使用快速的显微标记过程，在胫骨处称为骨料材料强度指数（BMSI）。一个 胫骨BMSI和骨折发生之间已经证明了显着且高度预测的关系 在多个骨骼部位。 BMSI也已被证明是股骨强度的强烈预测 脖子。由于脆弱性骨折经常发生在臀部，手腕和脊柱上，本研究将研究这种关系 在这些临床相关的骨骼部位的胫骨的骨探针测量和骨强度之间 绝经后尸体。我们假设胫骨骨探针测量将预测骨强度 在臀部，手腕和脊柱的整个骨骼和组织水平上。在这些骨骼部位，骨探针 将进行测量，BMD以及全骨和组织水平机械测试。该提议的目的 至：（1）建立机械基础，通过该基础，可以通过临床相关的体内骨骼强度替代 精确测量在臀部，手腕和脊柱上； （2）过渡骨探针到最终广告 针对目标商业环境中的可用性进行了优化的配置； （3）提供FDA批准 骨探针作为一种临床上有用的装置，旨在解决骨质质量诊断差距。

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