RADIOGRAPHIC PROGRESSION OF KNEE OSTEOARTHRITIS

膝骨关节炎的放射学进展

• 批准号: 6235628
• 负责人: KENNETH D BRANDT
• 金额: $ 14.94万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 1998-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6235628
• 关键词: clinical research; digital imaging; human middle age (35-64); human old age (65+); human subject; knee; longitudinal human study; musculoskeletal imaging /visualization /scanning; obesity; osteoarthritis; pathologic process; radiography

Basic research on articular cartilage biochemistry and metabolism has identified compounds (e.g., metalloproteinase inhibitors) that have shown great potential in animal models as disease-modifying drugs for osteoarthritis (DMOADs). The osteoarthritis (OA) research community is in general agreement that narrowing of the joint space (JSN), measured in serial radiographs, is a surrogate for loss of articular cartilage that can, with standardized positioning of the subject be measured with sufficient accuracy to permit detection of a DMOAD effect. However, research on the effects of DMOADs has been hampered by inconsistent and incomplete information on which to base decisions regarding the most appropriate target population(s) and primary outcome variables (i.e., measures reflecting progression f OA). It has been suggested that the presence of Heberden's nodes or results of bone scintigraphy may help identify subjects at increased risk for progressive OA and that recent epidemiologic data suggest that a select population of persons with radiographic evidence of unilateral knee OA and the cardinal risk factors for bilateral disease (female sex, obesity, middle age) may afford an opportunity to observe (and prevent) the rapid onset of OA in a joint at high risk for OA - i.e., the radiographically normal contralateral knee. However, the degree to which bony changes of OA in the high-risk contralateral knee of this select group (i.e. osteophytosis) are accompanied by JSN is unknown. The study proposed herein will provide information which will be useful in the design of future DMOAD trials; 150 subjects will be enrolled in a longitudinal study of OA progression: 60 women age 45-64 with radiographic evidence of unilateral knee OA, 30 men age 45-64 with bilateral knee OA, 30 women and 30 men age 65-74 with bilateral knee OA. Because obesity is a recognized risk factor for knee OA, all subjects will have body mass index (BMI) in the upper tertile for sex- , race-, and age-adjusted norms. Knee OA will be mild/moderate at baseline [osteophytes and greater than or equal to 2 mm of minimum medial tibiofemoral joint space width (JSW)]. Subjects will undergo x-ray examination of knees and hands and algofunctional assessment (WOMAC) at baseline. Those with unilateral knee OA will also undergo baseline bone scintigraphy, results of which will be related to x-ray changes over time to ascertain the predictive value of scintigraphy for progression of knee OA. Knee radiography will be repeated 15 and 30 months after baseline. Bony changes of knee OA (e.g., osteophytes, sclerosis) will be graded semiquantitatively while, for precision and generalizability to a future DMOAD trial, JSN will be quantitated from serial computerized measurements of minimum medial compartment of JSW in digitized images of both knees obtained with standardized positioning under fluoroscopy, with correction for image magnification.

关节软骨生物化学和代谢基础研究 已鉴定的化合物（例如金属蛋白酶抑制剂） 在动物模型中显示出作为疾病缓解药物的巨大潜力 骨关节炎（DMOAD）。 骨关节炎 (OA) 研究界 普遍认为关节间隙（JSN）变窄， 在连续射线照片中测量，是关节丧失的替代指标 软骨可以通过受试者的标准化定位 测量精度足以检测 DMOAD 影响。 然而，对 DMOAD 效果的研究受到了阻碍 决策所依据的信息不一致且不完整 关于最合适的目标人群和主要人群 结果变量（即反映 OA 进展的指标）。 有人建议赫伯登节点或结果的存在 骨闪烁扫描可能有助于识别患病风险增加的受试者 进行性 OA 和最近的流行病学数据表明 选择具有单侧放射学证据的人群 膝关节 OA 和双侧疾病的主要危险因素（女性 性别、肥胖、中年）可能提供观察的机会（以及 预防）骨关节炎高风险关节中骨关节炎的快速发作 - 即， 影像学正常的对侧膝关节。 然而，学位 高危对侧膝关节 OA 骨性变化 该选择组（即骨赘病）伴有 JSN 是 未知。 本文提出的研究将提供的信息将 对未来 DMOAD 试验的设计有用； 150 个科目将 参加了 OA 进展的纵向研究：60 名 45-64 岁的女性 有单侧膝关节 OA 的影像学证据，30 名年龄 45-64 岁的男性 患有双侧膝关节 OA，30 名女性和 30 名男性，年龄 65-74 岁，患有双侧膝关节骨关节炎 膝骨关节炎。 由于肥胖是膝关节 OA 的公认危险因素，因此所有 受试者的体重指数 (BMI) 处于性别的上三分位 - 、种族和年龄调整的规范。 膝盖 OA 为轻度/中度 基线[骨赘且最小大于或等于2毫米 内侧胫股关节间隙宽度（JSW）]。 受试者将经历 膝盖和手部的 X 射线检查以及算法功能评估 （WOMAC）基线。 单侧膝关节骨关节炎患者也将接受 基线骨闪烁扫描，其结果将与 X 射线相关 随着时间的推移而变化以确定闪烁扫描的预测价值 用于膝关节 OA 的进展。 将重复进行膝关节放射检查 15 且 基线后 30 个月。膝关节 OA 的骨变化（例如骨赘、 硬化症）将进行半定量分级，同时为了精度和 为了推广到未来的 DMOAD 试验，JSN 将从 JSW 最小内侧间室的连续计算机化测量 通过标准化获得的双膝数字化图像 透视下定位，并校正图像 放大。