Assessing Bone Health after SCI: Establishing Evidence for a Clinical Protocol

SCI 后评估骨骼健康：为临床方案建立证据

• 批准号: 9910070
• 负责人: Beatrice Jenny Kiratli
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9910070
• 关键词: Address; Affect; Age-Related Osteoporosis; Age-Years; Americas; Area; Articular Range of Motion; Assessment tool; Awareness; Bone Density; Cardiovascular Diseases; Caring; Chromosome Fragile Sites; Chronic; Clinical; Clinical Protocols; Consensus; Data; Databases; Development; Diabetes Mellitus; Direct Costs; Distal; Dual-Energy X-Ray Absorptiometry; Emerging Technologies; Facilities and Administrative Costs; Female; Femur; Fracture; Future; Gender; Goals; Gold; Guidelines; Health; Health Benefit; Hip region structure; Hospitalization; Incidence; Individual; Injury; Judgment; Knee; Knowledge; Lead; Leg; Leisures; Life Expectancy; Location; Lower Extremity; Lung diseases; Maintenance; Measurement; Measures; Medical Care Costs; Monitor; Musculoskeletal; Obesity; Osteoporosis; Paralysed; Patients; Peripheral; Persons; Physicians; Play; Population; Protocols documentation; Provider; Range of motion exercise; Recommendation; Recording of previous events; Recreation; Reference Values; Rehabilitation therapy; Research; Resolution; Risk; Risk Assessment; Scanning; Severities; Site; Spinal cord injury; Sports; Standardization; Technology; Testing; Time; United States; Vertebral column; Veterans; accurate diagnosis; active lifestyle; bone; bone health; bone loss; care costs; care providers; clinical implementation; clinically relevant; cost; evidence base; exoskeleton; experience; fracture risk; fragility fracture; health administration; hip bone; inclusion criteria; life time cost; limb fracture; male; medical complication; new technology; novel; patient safety; productivity loss; recruit; skeletal; tibia

The Veterans Health Administration (VHA) is the largest single provider of heath care to individuals with spinal cord injury (SCI) in the United States. For 2016, Paralyzed Veterans of America estimates that 43,000 veterans with SCI received care from VHA. The annual cost of that care is substantial. In 2015, the total costs during the first year following an SCI ranged from $520K to $1.1M; recurring costs ranged from $69K to $185K per patient per year. Lifetime costs also continue to increase as life expectancy post-SCI increases. A key contributor to the high medical cost post-SCI is fragility fracture, often requiring prolonged hospitalization and specialized care. Up to three-quarters of individuals with SCI will sustain a fragility fracture in their lifetime. Fractures lead to serious medical complications, a loss of independence, and a loss of productivity, all resulting in substantial direct and indirect costs. SCI clinicians and patients agree that maintaining an active lifestyle is critical not only for general health, but also for musculoskeletal health. Given the substantial loss of bone that occurs in the lower limbs following SCI, however, clinicians must always be cognizant of the possibility of fracture, especially for those with more chronic injuries. Bone mineral density (BMD) measurement from a Dual-energy X-ray Absorptiometry (DXA) scan is the clinical gold standard for osteoporosis assessment in able-bodied individuals. Accurate diagnosis is important since it guides treatment and it helps to inform patients and doctors what activities can and can't be performed safely. Unlike the case with able-bodied individuals, there is no clinical standard and no consensus for assessing skeletal health in the lower limbs of individuals with SCI. For able-bodied individuals, the standard sites for scanning are the spine and hip, which are common sites of fracture in those with age-related osteoporosis. For those with SCI, however, most fractures occur just above and just below the knee. Hip and spine BMD are not good predictors of fracture at distal sites in the legs and, at present, no standardized protocols exist for assessing skeletal health near the knee. SCI clinicians continue to be faced with a critical question which is: Is it safe for my patient to participate in certain rehabilitation activities, recreation and sports activities, or to use an exoskeleton for ambulation? Currently, there is no evidence-based answer to that question. The purpose of this project is to validate scan protocols for bone mineral density assessment that will enable clinicians to address that issue. This in turn will allow clinicians to prescribe and monitor rehabilitation therapies and recreational activities that are appropriate for a particular patient given his or her skeletal heath. Over the past three decades more than a dozen different protocols have been proposed for scanning the area above and below the knee in patients with SCI, including nine protocols introduced since 2005. Those protocols have not been comprehensively assessed or compared for sensitivity or precision, nor have normative, reference values been determined for able-bodied individuals. Our study has four Specific Aims. Aim 1 is to generate normative databases for the multiple DXA protocols that have been proposed for bone density scanning of the distal femur and proximal tibia. Aim 2 is to determine and rank the precision of those protocols in able-bodied individuals. Aim 3 is to the determine precision for the knee DXA protocols examined in Aim 1, but in individuals with SCI >4 years post-injury, and to see if High-Resolution QCT and peripheral- QCT scanning provide clinically valuable complementary data compared to DXA. Aim 4 is to measure bone changes over time in patients 1 to 4 years post-injury and, for DXA, to compare those changes to the least detectable change determined from the precision for each candidate knee DXA protocol. The results of this study will have immediate clinical utility and will lay the groundwork for future development of a fracture risk assessment tool specific for persons with SCI, comparable to risk assessment tools already available for able- bodied individuals. Clinical implementation of validated DXA protocols will be the immediate next step.

退伍军人卫生管理局（VHA）是最大的卫生护理提供商 美国的脊髓损伤（SCI）。 2016年，美国退伍军人估计有43,000 SCI的退伍军人从VHA获得了护理。该护理的年度费用是巨大的。在2015年，总费用 在一年之后的第一年，科幻范围从520k美元到110万美元不等；经常性费用从$ 69K到$ 185K不等 每年患者。随着SCI后预期寿命的增加，终生成本也继续增加。钥匙 SCI之后的高医疗费用的贡献是脆弱性骨折，通常需要长时间住院和 专业护理。多达四分之三患有SCI的人将在一生中维持脆弱性骨折。 骨折导致严重的医疗并发症，失去独立性和生产力降低，所有这些都导致 在大量直接和间接成本中。 SCI临床医生和患者同意保持积极的生活方式是 不仅对一般健康至关重要，而且对肌肉骨骼健康也至关重要。考虑到骨骼的大量损失 然而，在SCI之后的下肢发生，临床医生必须始终认识到 骨折，特别是对于那些慢性伤害的人。 通过双能X射线吸收法（DXA）扫描的骨矿物质密度（BMD）测量 健美个体的骨质疏松评估的临床金标准。准确的诊断很重要 由于它指导治疗，并且有助于通知患者和医生可以进行哪些活动可以做到什么 安全。与健全的人不同，没有临床标准，也没有共识 评估SCI患者下肢的骨骼健康。对于健全的人，标准 扫描的部位是脊柱和臀部，它们是与年龄有关的骨折的常见部位 骨质疏松症。但是，对于患有SCI的人，大多数骨折都出现在膝盖上方和下方。臀部和 脊柱BMD不是腿部远端部位裂缝的好预测指标，目前尚无标准化 存在用于评估膝盖附近骨骼健康的方案。 SCI临床医生继续面对关键 问题是：我的患者参加某些康复活动，娱乐和运动是否安全 活动，还是使用外骨骼进行行动？目前，没有证据的答案 问题。该项目的目的是验证扫描方案的骨矿物质密度评估，该方案将 使临床医生能够解决这个问题。反过来，这将使临床医生开处方和监视康复 鉴于他或她的骨骼健康，适合特定患者的疗法和娱乐活动。 在过去的三十年中，已经提出了十几个不同的协议来扫描 SCI患者膝盖上方和下方的区域，包括自2005年以来引入的九种方案。 协议尚未经过全面评估或比较敏感性或精度，也没有 规范性的参考值已确定针对健全的个体。我们的研究有四个具体的目标。 AIM 1是生成针对骨骼提出的多个DXA协议的规范数据库 股骨远端和胫骨近端的密度扫描。 AIM 2是确定并排名这些精度 健全的个体方案。 AIM 3是确定检查的膝盖DXA协议的精度 在AIM 1中，但在受伤后4年的人中，要查看高分辨率QCT和外围 - 与DXA相比，QCT扫描提供临床上有价值的互补数据。目标4是测量骨头 伤害后1至4年的患者随时间变化，而DXA则比较这些更改 可检测的变化是根据每个候选膝关节DXA方案的精度确定的。结果的结果 研究将立即具有临床实用性，并将为未来开发破裂风险奠定基础 评估工具特定于具有SCI的人，可与风险评估工具相媲美 身体的个体。经过验证的DXA协议的临床实施将是下一步。