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.

退伍军人健康管理局（VHA）是最大的单一医疗保健提供者， 脊髓损伤（SCI）在美国2016年，美国瘫痪退伍军人协会估计， 患有脊髓损伤的退伍军人得到了VHA的照顾。这种护理每年的费用是巨大的。2015年，总成本 在SCI后的第一年，范围从52万美元到110万美元;经常性成本范围从6.9万美元到18.5万美元 每名患者每年。随着SCI后预期寿命的增加，终身成本也继续增加。一个关键 造成SCI后高医疗费用的一个因素是脆性骨折，通常需要长期住院， 专业护理。多达四分之三的SCI患者在其一生中会发生脆性骨折。 骨折会导致严重的医疗并发症，丧失独立性和生产力的损失，所有这些都导致 直接和间接的成本。SCI临床医生和患者都认为，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。考虑到大量的骨质流失， 然而，临床医生必须始终认识到脊髓损伤后下肢的可能性， 骨折，特别是对于那些有更多的慢性损伤。 双能X射线吸收测定法（DXA）扫描的骨矿物质密度（BMD）测量值是 健康个体骨质疏松症评估的临床金标准。准确的诊断很重要 因为它可以指导治疗，并有助于告知患者和医生哪些活动可以和不可以进行， 平安与健全人的情况不同，没有临床标准，也没有共识。 评估SCI患者下肢的骨骼健康状况。对于身体健全的个人， 扫描的部位是脊柱和髋部，这是年龄相关性骨折的常见部位。 骨质疏松然而，对于那些SCI患者来说，大多数骨折发生在膝盖上方和下方。髋关节和 脊柱骨密度不是腿部远端骨折的良好预测因子，目前， 存在用于评估膝盖附近的骨骼健康的规程。SCI临床医生继续面临着一个关键的 问题是：我的病人参加某些康复活动、娱乐和体育活动是否安全 活动，或使用外骨骼的american？目前，对此没有基于证据的答案 问题本项目的目的是验证骨矿物质密度评估的扫描协议， 使临床医生能够解决这个问题。这反过来将使临床医生处方和监测康复 治疗和娱乐活动，适合于特定患者的骨骼健康。 在过去的三十年里，已经提出了十几种不同的协议来扫描 在SCI患者的膝上和膝下区域，包括自2005年以来推出的9项协议。那些 协议尚未全面评估或比较的灵敏度或精度，也没有 已确定健全个体的标准参考值。我们的研究有四个具体目标。 目的1是为骨的多个DXA协议生成规范数据库 股骨远端和胫骨近端密度扫描。目标2是确定和排序的精度， 身体健全的人的协议。目的3是确定膝关节DXA检查方案的精度 在目标1中，但在损伤后>4年的SCI患者中，并观察高分辨率QCT和外周- 与DXA相比，QCT扫描提供了有临床价值的补充数据。目的4是测量骨 损伤后1至4年患者随时间的变化，对于DXA，将这些变化与最小 根据每个候选膝关节DXA方案的精密度确定的可检测变化。的结果 这项研究将立即具有临床实用性，并将为骨折风险的未来发展奠定基础。 专门针对SCI患者的评估工具，与已有的风险评估工具相当- 身体的个体。经验证的DXA方案的临床实施将是紧接着的下一步。