骨关节炎倡议 (OAI):膝关节健康研究
膝骨关节炎 (OA) 是成人残疾的最常见原因。
“骨关节炎倡议 (OAI):膝关节健康研究”是一项全国性的研究,它将帮助研究人员收集更多关于关节炎症状出现之前或 OA 恶化之前发生的身体变化的信息。
本研究的目的是检查患有膝骨关节炎或膝骨关节炎高风险的人;这些信息将用于更好地了解如何预防和治疗膝关节 OA。
研究概览
详细说明
与任何其他形式的关节炎相比,膝关节 OA 会导致更多的健康问题和医疗费用。 OA 的症状范围从僵硬和轻度疼痛到严重的关节痛甚至残疾。 先前的研究表明,某些因素,例如膝关节疼痛、既往膝关节损伤或膝关节手术、手部 OA 或肥胖,可能会导致膝关节 OA。 OAI 是一项膝关节 OA 的多中心观察性研究,将收集有关 OA 的潜在生物标志物以及 OA 发病和进展趋势的信息。
OAI 将在四个临床中心之一招募并跟踪患有膝关节 OA 或有发生膝关节 OA 高风险的参与者 8 年。 血液和尿液收集、磁共振成像 (MRI) 和 X 射线将在四次年度随访中的每一次完成。 筛选时的问卷调查和体格检查将评估膝骨关节炎发生和进展的危险因素。 膝盖疼痛和身体残疾的程度将在研究开始时和每次随访时通过问卷调查和检查进行评估。
研究类型
观察性的
注册 (实际的)
4796
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins University
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Ohio
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Columbus、Ohio、美国、43210
- Ohio State University
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
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Rhode Island
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Pawtucket、Rhode Island、美国、02860
- Memorial Hospital of Rhode Island / Brown University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 至 79年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
患有膝关节 OA 或发生膝关节 OA 的风险高的参与者
描述
纳入标准:
必须满足以下条件之一:
- 超重
- 以前的膝盖受伤或手术
- 过去一年膝盖疼痛。 参与者不需要有当前的膝盖疼痛来参与研究。
- 做过膝关节置换术的父母或兄弟姐妹
排除标准:
- 类风湿关节炎
- 双膝关节置换
- 没有帮助无法行走
- 无法接受膝关节核磁共振检查
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Gayle Lester, PhD、National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Mohajer B, Dolatshahi M, Moradi K, Najafzadeh N, Eng J, Zikria B, Wan M, Cao X, Roemer FW, Guermazi A, Demehri S. Role of Thigh Muscle Changes in Knee Osteoarthritis Outcomes: Osteoarthritis Initiative Data. Radiology. 2022 Oct;305(1):169-178. doi: 10.1148/radiol.212771. Epub 2022 Jun 21.
- Li J, Fu S, Gong Z, Zhu Z, Zeng D, Cao P, Lin T, Chen T, Wang X, Lartey R, Kwoh CK, Guermazi A, Roemer FW, Hunter DJ, Ma J, Ding C. MRI-based Texture Analysis of Infrapatellar Fat Pad to Predict Knee Osteoarthritis Incidence. Radiology. 2022 Sep;304(3):611-621. doi: 10.1148/radiol.212009. Epub 2022 May 31.
- Steidle-Kloc E, Dannhauer T, Wirth W, Eckstein F. Responsiveness of Subcutaneous Fat, Intermuscular Fat, and Muscle Anatomical Cross-Sectional Area of the Thigh to Longitudinal Body Weight Loss and Gain: Data from the Osteoarthritis Initiative (OAI). Cells Tissues Organs. 2022;211(5):555-564. doi: 10.1159/000520037. Epub 2021 Oct 7.
- Canton G, Hippe DS, Chen L, Waterton JC, Liu W, Watase H, Balu N, Sun J, Hatsukami TS, Yuan C. Atherosclerotic Burden and Remodeling Patterns of the Popliteal Artery as Detected in the Magnetic Resonance Imaging Osteoarthritis Initiative Data Set. J Am Heart Assoc. 2021 Jun;10(11):e018408. doi: 10.1161/JAHA.120.018408. Epub 2021 May 17.
- Hu B, Han D, Nevitt MC, Wise BL, Segal NA. Longitudinal Relationship Between Physical Activity and Joint Space Narrowing: Forty-Eight-Month Follow-Up Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2022 Jul;74(7):1163-1171. doi: 10.1002/acr.24554. Epub 2022 Apr 13.
- Eckstein F, Chaudhari AS, Fuerst D, Gaisberger M, Kemnitz J, Baumgartner CF, Konukoglu E, Hunter DJ, Wirth W. Detection of Differences in Longitudinal Cartilage Thickness Loss Using a Deep-Learning Automated Segmentation Algorithm: Data From the Foundation for the National Institutes of Health Biomarkers Study of the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2022 Jun;74(6):929-936. doi: 10.1002/acr.24539. Epub 2022 Apr 1.
- Campbell TM, Ramsay T, Trudel G. Knee Flexion Contractures Are Associated with Worse Pain, Stiffness, and Function in Patients with Knee Osteoarthritis: Data from the Osteoarthritis Initiative. PM R. 2021 Sep;13(9):954-961. doi: 10.1002/pmrj.12497. Epub 2020 Nov 10.
- Roth M, Emmanuel K, Wirth W, Kwoh CK, Hunter DJ, Hannon MJ, Eckstein F. Changes in Medial Meniscal Three-Dimensional Position and Morphology As Predictors of Knee Replacement in Rapidly Progressing Knee Osteoarthritis: Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2021 Jul;73(7):1031-1037. doi: 10.1002/acr.24193.
- Haj-Mirzaian A, Mohajer B, Guermazi A, Conaghan PG, Lima JAC, Blaha MJ, Bingham CO, Roemer FW, Cao X, Demehri S. Statin Use and Knee Osteoarthritis Outcome Measures according to the Presence of Heberden Nodes: Results from the Osteoarthritis Initiative. Radiology. 2019 Nov;293(2):396-404. doi: 10.1148/radiol.2019190557. Epub 2019 Sep 10.
- Ruhdorfer A, Wirth W, Culvenor AG, Eckstein F. Reduction in Thigh Muscle Strength Occurs Concurrently but Does Not Seem to Precede Incident Knee Pain in Women: Data From the Osteoarthritis Initiative Cohort. Am J Phys Med Rehabil. 2020 Jan;99(1):33-40. doi: 10.1097/PHM.0000000000001271.
- Wirth W, Maschek S, Roemer FW, Sharma L, Duda GN, Eckstein F. Radiographically normal knees with contralateral joint space narrowing display greater change in cartilage transverse relaxation time than those with normal contralateral knees: a model of early OA? - data from the Osteoarthritis Initiative (OAI). Osteoarthritis Cartilage. 2019 Nov;27(11):1663-1668. doi: 10.1016/j.joca.2019.06.013. Epub 2019 Jul 10.
- Eckstein F, Maschek S, Roemer FW, Duda GN, Sharma L, Wirth W. Cartilage loss in radiographically normal knees depends on radiographic status of the contralateral knee - data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2019 Feb;27(2):273-277. doi: 10.1016/j.joca.2018.10.006. Epub 2018 Oct 28.
- Bricca A, Wirth W, Juhl CB, Kemnitz J, Hunter DJ, Kwoh CK, Eckstein F, Culvenor AG. Moderate Physical Activity and Prevention of Cartilage Loss in People With Knee Osteoarthritis: Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2019 Feb;71(2):218-226. doi: 10.1002/acr.23791.
- Jacobs CA, Vranceanu AM, Thompson KL, Lattermann C. Rapid Progression of Knee Pain and Osteoarthritis Biomarkers Greatest for Patients with Combined Obesity and Depression: Data from the Osteoarthritis Initiative. Cartilage. 2020 Jan;11(1):38-46. doi: 10.1177/1947603518777577. Epub 2018 Jun 1.
- Hu B, Skou ST, Wise BL, Williams GN, Nevitt MC, Segal NA. Lower Quadriceps Rate of Force Development Is Associated With Worsening Physical Function in Adults With or at Risk for Knee Osteoarthritis: 36-Month Follow-Up Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2018 Jul;99(7):1352-1359. doi: 10.1016/j.apmr.2017.12.027. Epub 2018 Jan 31.
- Wirth W, Hunter DJ, Nevitt MC, Sharma L, Kwoh CK, Ladel C, Eckstein F. Predictive and concurrent validity of cartilage thickness change as a marker of knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Dec;25(12):2063-2071. doi: 10.1016/j.joca.2017.08.005. Epub 2017 Aug 31.
- Steidle-Kloc E, Culvenor AG, Dorrenberg J, Wirth W, Ruhdorfer A, Eckstein F. Relationship Between Knee Pain and Infrapatellar Fat Pad Morphology: A Within- and Between-Person Analysis From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2018 Apr;70(4):550-557. doi: 10.1002/acr.23326. Epub 2018 Mar 11.
- Kemnitz J, Wirth W, Eckstein F, Ruhdorfer A, Culvenor AG. Longitudinal change in thigh muscle strength prior to and concurrent with symptomatic and radiographic knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Oct;25(10):1633-1640. doi: 10.1016/j.joca.2017.07.003. Epub 2017 Jul 8.
- Veronese N, Stubbs B, Noale M, Solmi M, Vaona A, Demurtas J, Nicetto D, Crepaldi G, Schofield P, Koyanagi A, Maggi S, Fontana L. Fried potato consumption is associated with elevated mortality: an 8-y longitudinal cohort study. Am J Clin Nutr. 2017 Jul;106(1):162-167. doi: 10.3945/ajcn.117.154872. Epub 2017 Jun 7.
- Wirth W, Maschek S, Beringer P, Eckstein F. Subregional laminar cartilage MR spin-spin relaxation times (T2) in osteoarthritic knees with and without medial femorotibial cartilage loss - data from the Osteoarthritis Initiative (OAI). Osteoarthritis Cartilage. 2017 Aug;25(8):1313-1323. doi: 10.1016/j.joca.2017.03.013. Epub 2017 Mar 27.
- Veronese N, Stubbs B, Noale M, Solmi M, Luchini C, Maggi S. Adherence to the Mediterranean diet is associated with better quality of life: data from the Osteoarthritis Initiative. Am J Clin Nutr. 2016 Nov;104(5):1403-1409. doi: 10.3945/ajcn.116.136390. Epub 2016 Sep 28.
- Collins JE, Deshpande BR, Katz JN, Losina E. Race- and Sex-Specific Incidence Rates and Predictors of Total Knee Arthroplasty: Seven-Year Data From the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2016 Jul;68(7):965-73. doi: 10.1002/acr.22771.
- Eckstein F, Collins JE, Nevitt MC, Lynch JA, Kraus VB, Katz JN, Losina E, Wirth W, Guermazi A, Roemer FW, Hunter DJ; FNIH OA Biomarkers Consortium. Brief Report: Cartilage Thickness Change as an Imaging Biomarker of Knee Osteoarthritis Progression: Data From the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Arthritis Rheumatol. 2015 Dec;67(12):3184-9. doi: 10.1002/art.39324.
- Eckstein F, Kwoh CK, Link TM; OAI investigators. Imaging research results from the osteoarthritis initiative (OAI): a review and lessons learned 10 years after start of enrolment. Ann Rheum Dis. 2014 Jul;73(7):1289-300. doi: 10.1136/annrheumdis-2014-205310. Epub 2014 Apr 12.
- Baum T, Joseph GB, Arulanandan A, Nardo L, Virayavanich W, Carballido-Gamio J, Nevitt MC, Lynch J, McCulloch CE, Link TM. Association of magnetic resonance imaging-based knee cartilage T2 measurements and focal knee lesions with knee pain: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2012 Feb;64(2):248-55. doi: 10.1002/acr.20672.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年2月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2004年3月24日
首先提交符合 QC 标准的
2004年3月24日
首次发布 (估计)
2004年3月25日
研究记录更新
最后更新发布 (实际的)
2020年9月29日
上次提交的符合 QC 标准的更新
2020年9月25日
最后验证
2009年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.