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: 10377394
• 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 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377394
• 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; 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; Respiratory Disease; Risk; Risk Assessment; Scanning; Severities; Site; Spinal cord injury; Sports; Standardization; Technology; Testing; Time; United States; Vertebral column; Veterans; Veterans Health Administration; 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; 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) 是向患有以下疾病的个人提供医疗保健的最大单一提供商 美国脊髓损伤（SCI）。美国瘫痪退伍军人协会估计 2016 年有 43,000 患有 SCI 的退伍军人接受 VHA 的护理。每年的护理费用是巨大的。 2015年，总成本 SCI 后第一年的费用从 52 万美元到 110 万美元不等；经常性成本从 6.9 万美元到 18.5 万美元不等 每名患者每年。随着 SCI 后预期寿命的延长，终生成本也持续增加。一把钥匙 造成 SCI 后高额医疗费用的原因是脆性骨折，通常需要长期住院治疗 专门护理。多达四分之三的 SCI 患者一生中都会经历脆性骨折。 骨折会导致严重的医疗并发症、丧失独立性和生产力丧失，所有这些都会导致 造成巨大的直接和间接成本。 SCI 临床医生和患者一致认为，保持积极的生活方式是 不仅对整体健康至关重要，而且对肌肉骨骼健康也至关重要。鉴于骨质大量流失 SCI 后发生于下肢，然而，临床医生必须始终认识到以下可能性： 骨折，尤其是那些患有更多慢性损伤的人。 双能 X 射线吸收测定法 (DXA) 扫描的骨矿物质密度 (BMD) 测量结果是 健全个体骨质疏松症评估的临床金标准。准确诊断很重要 因为它指导治疗并有助于告知患者和医生哪些活动可以进行，哪些活动不能进行 安全。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。对于身体健全的人来说，标准 扫描部位是脊柱和髋部，这是与年龄相关的人骨折的常见部位 骨质疏松症。然而，对于 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 BMD 并不是腿部远端骨折的良好预测指标，目前还没有标准化的方法 现有评估膝盖附近骨骼健康状况的方案。 SCI 临床医生继续面临严峻的挑战 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走？目前，还没有基于证据的答案 问题。该项目的目的是验证骨矿物质密度评估的扫描协议，该协议将 使临床医生能够解决这个问题。这反过来又将使临床医生能够开出处方并监测康复情况 适合特定患者骨骼健康状况的治疗和娱乐活动。 在过去的三十年里，已经提出了十多种不同的协议来扫描 SCI 患者膝盖上方和下方区域，包括自 2005 年以来推出的九种方案。 方案的敏感性或精确度尚未经过全面评估或比较，也没有 为身体健全的个人确定了规范的参考值。我们的研究有四个具体目标。 目标 1 是为已针对骨提出的多个 DXA 协议生成规范数据库 股骨远端和胫骨近端的密度扫描。目标 2 是确定这些结果的精度并对其进行排名 身体健全的个人的协议。目标 3 是确定所检查的膝部 DXA 协议的精度 在目标 1 中，但在损伤后 4 年以上的 SCI 个体中，并观察高分辨率 QCT 和外周血管是否 与 DXA 相比，QCT 扫描可提供具有临床价值的补充数据。目标 4 是测量骨骼 患者受伤后 1 至 4 年随时间的变化，对于 DXA，将这些变化进行最小比较 根据每个候选膝盖 DXA 协议的精度确定的可检测变化。这样做的结果 研究将具有直接的临床实用性，并将为未来骨折风险的发展奠定基础 专门针对 SCI 患者的评估工具，与已有的针对有能力的人可用的风险评估工具相当 身体健全的个体。下一步将是验证 DXA 方案的临床实施。