Bringing medical advances from the lab to the clinic.
骨关节炎（Osteoarthritis, OA）是一种由关节软骨退化引起的慢性关节疾病，是最常见的关节病类型之一。这种疾病通常影响中老年人，尤其是负重关节，如膝盖、髋关节和手关节。
缺乏根治治疗：目前的治疗方法主要是缓解症状和改善关节功能，但没有办法彻底治愈骨关节炎或逆转关节软骨的损伤。 疼痛管理：疼痛是骨关节炎患者最常见的抱怨，有效的疼痛管理对提高生活质量至关重要，但目前常用的非甾体抗炎药（NSAIDs）和鸦片类药物长期使用可能有副作用和依赖性问题。 早期诊断：早期诊断骨关节炎仍然是一个挑战，特别是在没有明显症状的早期阶段，缺乏有效的生物标志物和成像技术来检测早期软骨损伤。 个体化治疗：由于骨关节炎的病因和症状差异很大，需要更多的研究来理解不同患者的具体病理机制，以便开发更加个性化的治疗策略。 非药物治疗的效果评估：虽然物理治疗和生活方式改变等非药物治疗在管理骨关节炎中起着重要作用，但关于这些干预措施的长期效果和最佳实施策略仍需要更多科学证据支持。
BOSTON UNIVERSITY MEDICAL CAMPUS 的 FELSON, DAVID TOBIN
UNIVERSITY OF ARIZONA 的 KWOH, C KENT WAKE FOREST UNIVERSITY 的 MESSIER, STEPHEN P ZETROZ SYSTEMS, LLC 的 LEWIS, GEORGE KENNETH UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 的 COLLINS, KELSEY HELEN-MARIE
波士顿大学医学院 北卡罗来纳大学教堂山分校
加州大学旧金山分校
亚利桑那大学
密歇根大学安娜堡分校等
The objective of this Phase III, multi-site (Boston, MA, Chapel Hill, NC, Broward County, FL, Sydney, Australia, and Winston-Salem, NC) randomized clinical trial is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee OA prevention.
Participants will be 1,230 ambulatory, community dwelling females with obesity (BMI ≥ 30 kg/m2), and aged ≥ 50 years. Structural and symptomatic eligibility will be determined at the individual knee level. The eligible knee will have no radiographic (Kellgren Lawrence (KL) score ≤ 1) and no MRI knee OA with no or infrequent knee pain (< 15 days/month) in the same knee.
The primary aim is to compare the effects of a 48-month intervention of dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural (MRI) knee OA using the MRI OA Knee Score (MOAKS).
Secondary aims will determine the intervention effects on the Knee Injury and Osteoarthritis Outcome Score (KOOS total), KOOS pain, mobility (6 minute walk distance), and health-related quality of life (SF-36). Mechanistic secondary outcomes include knee joint compressive forces as a measure of joint loading, IL-6 as an inflammatory measure, and weight loss and exercise self-efficacy. We will also establish the cost-effectiveness of this intervention.
This study is significant in that it will test a critically needed primary prevention intervention of dietary weight loss, exercise, and weight-loss maintenance for females at risk for knee OA.
The current proposal is a critical first step in evaluating the clinical relevance of change in JSW in terms of pain and function, as well as evaluation of risk factors.
It uses pooled data from three of the largest and most diverse longitudinal observational studies of KOA: the Johnston County Osteoarthritis Project (JoCoOA), a population-based cohort; and the Multicenter Osteoarthritis Study (MOST) and the Osteoarthritis Initiative (OAI), two cohorts of individuals with or at risk of developing symptomatic KOA. Over multiple visits, these three cohorts, together comprising ~10,500 participants, collected comparable data on demographics, risk factors, patient-reported outcomes, and identical weightbearing fixed flexion knee radiographs scored for OA severity.
The specific aims are to 1.) Describe the natural history of healthy knee aging in disease-free knees; 2.) Identify subgroups of knees based on longitudinal changes in knee structure, pain and function across the spectrum from healthy knee aging to rapid OA progression; and 3.) Evaluate the clinical relevance of JSW changes for an individual knee based on concurrent risk of increased pain and functional limitations, and for future knee replacement. These aims will be addressed separately for men and women, and separately for whites and African Americans.
