Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
2026年8月1日 更新者：Rehab Awad Mohamed Ahmed、Assiut University
Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
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。
学习联系方式
- 姓名：Rehab Awad Mohamed
- 电话号码：2+01011511722
- 邮箱：RehabAwad@aun.edu.eg
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Clinical diagnosis of knee osteoarthritis according to the criteria of the American College of Rheumatology.
Radiographic evidence of osteoarthritis corresponding to Kellgren-Lawrence grades I-III.
Moderate to severe knee pain for at least 6 months. Visual Analog Scale (VAS) score ≥5.
- Failure of conservative treatment for at least 3 months including analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, lifestyle modification, or intra-articular injections.
Exclusion Criteria:
- Kellgren-Lawrence grade IV osteoarthritis.
- Previous knee arthroplasty.
- Inflammatory arthropathies such as rheumatoid arthritis, psoriatic arthritis, or gout.
- Active local or systemic infection.
- Severe peripheral arterial disease.
- Coagulation disorders.
- Renal insufficiency (raised renal chemistry).
- Pregnancy.
- Known allergy to iodinated contrast media.
- Refuse to provide written informed consent
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：genicular artery embolization
Participants with symptomatic knee osteoarthritis will undergo super-selective genicular artery embolization using calibrated microspheres.
Clinical outcomes will be assessed using pain and functional scores during follow-up.
|
Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.
Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.
A 2.0-2.4
Fr microcatheter used for super-selective catheterization of the genicular arteries.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change from baseline in visual analog scale (VAS) pain score
大体时间：Baseline and 6 months after the Procedure
|
pain intensity measured using the 10-cm visual analog scale (VAS).
scores range from 0 to 10, with higher scores indicating greater pain.
The change from baseline to 6 months after genicular artery embolization will be assessed.
|
Baseline and 6 months after the Procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Technical Success Rate of Genicular Artery Embolization
大体时间：During the procedure
|
Technical success is defined as successful selective catheterization and embolization of all target genicular arteries with completion of the planned procedure.
|
During the procedure
|
|
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
大体时间：Baseline, 3 months, and 6 months after the procedure
|
Knee pain, stiffness, and physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
The total WOMAC score ranges from 0 to 96, where 0 indicates no symptoms and 96 indicates the most severe symptoms.
Higher scores indicate worse pain, stiffness, and functional limitation.
|
Baseline, 3 months, and 6 months after the procedure
|
|
Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)
大体时间：Baseline and 6 months after the procedure
|
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The EQ-5D-5L descriptive system consists of five dimensions, each with five levels, and responses are converted into a utility index score ranging from values below 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health-related quality of life.
Assessments will be performed at baseline, 3 months, and 6 months after the procedure.
|
Baseline and 6 months after the procedure
|
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：Moustafa Hashim Mahmoud、Assiut University
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
- Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.
- Crawford DC, Miller LE, Block JE. Conservative management of symptomatic knee osteoarthritis: a flawed strategy? Orthop Rev (Pavia). 2013 Feb 22;5(1):e2. doi: 10.4081/or.2013.e2. Print 2013 Feb 22.
- Lyu SR, Chiang JK, Tseng CE. Medial plica in patients with knee osteoarthritis: a histomorphological study. Knee Surg Sports Traumatol Arthrosc. 2010 Jun;18(6):769-76. doi: 10.1007/s00167-009-0946-2. Epub 2009 Oct 14.
- Bohnsack M, Meier F, Walter GF, Hurschler C, Schmolke S, Wirth CJ, Ruhmann O. Distribution of substance-P nerves inside the infrapatellar fat pad and the adjacent synovial tissue: a neurohistological approach to anterior knee pain syndrome. Arch Orthop Trauma Surg. 2005 Nov;125(9):592-7. doi: 10.1007/s00402-005-0796-4.
- Walsh DA, Bonnet CS, Turner EL, Wilson D, Situ M, McWilliams DF. Angiogenesis in the synovium and at the osteochondral junction in osteoarthritis. Osteoarthritis Cartilage. 2007 Jul;15(7):743-51. doi: 10.1016/j.joca.2007.01.020. Epub 2007 Mar 21.
- Mapp PI, Walsh DA. Mechanisms and targets of angiogenesis and nerve growth in osteoarthritis. Nat Rev Rheumatol. 2012 May 29;8(7):390-8. doi: 10.1038/nrrheum.2012.80.
- Kurien T, Kerslake RW, Graven-Nielsen T, Arendt-Nielsen L, Auer DP, Edwards K, Scammell BE, Petersen KK. Chronic postoperative pain after total knee arthroplasty: The potential contributions of synovitis, pain sensitization and pain catastrophizing-An explorative study. Eur J Pain. 2022 Oct;26(9):1979-1989. doi: 10.1002/ejp.2018. Epub 2022 Aug 19.
- Sideris A, Malahias MA, Birch G, Zhong H, Rotundo V, Like BJ, Otero M, Sculco PK, Kirksey M. Identification of biological risk factors for persistent postoperative pain after total knee arthroplasty. Reg Anesth Pain Med. 2022 Mar;47(3):161-166. doi: 10.1136/rapm-2021-102953. Epub 2021 Dec 17.
- Marsh J, Joshi I, Somerville L, Vasarhelyi E, Lanting B. Health care costs after total knee arthroplasty for satisfied and dissatisfied patients. Can J Surg. 2022 Sep 1;65(5):E562-E566. doi: 10.1503/cjs.006721. Print 2022 Sep-Oct.
- Hawker GA, Guan J, Croxford R, Coyte PC, Glazier RH, Harvey BJ, Wright JG, Williams JI, Badley EM. A prospective population-based study of the predictors of undergoing total joint arthroplasty. Arthritis Rheum. 2006 Oct;54(10):3212-20. doi: 10.1002/art.22146.
- Ashraf S, Wibberley H, Mapp PI, Hill R, Wilson D, Walsh DA. Increased vascular penetration and nerve growth in the meniscus: a potential source of pain in osteoarthritis. Ann Rheum Dis. 2011 Mar;70(3):523-9. doi: 10.1136/ard.2010.137844. Epub 2010 Nov 15.
- Pap T, Distler O. Linking angiogenesis to bone destruction in arthritis. Arthritis Rheum. 2005 May;52(5):1346-8. doi: 10.1002/art.21015. No abstract available.
- Bonnet CS, Walsh DA. Osteoarthritis, angiogenesis and inflammation. Rheumatology (Oxford). 2005 Jan;44(1):7-16. doi: 10.1093/rheumatology/keh344. Epub 2004 Aug 3.
- Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014.
- Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
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 (估计的)
2026年8月1日
初级完成 (估计的)
2028年8月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月25日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年8月1日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- angioembolization in knee OA
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研究美国 FDA 监管的设备产品
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