Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

Официальное название

Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

Обзор

To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.

Вмешательства

• Процедура genicular artery embolization
  Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.
• Устройство Calibrated microspheres (100-300 µm)
  Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.
• Устройство Microcatheter
  A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.

Первичные конечные точки

• change from baseline in visual analog scale (VAS) pain score [Срок оценки: Baseline and 6 months after the Procedure]

Вторичные конечные точки (3)

• Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score [Срок оценки: Baseline, 3 months, and 6 months after the procedure]
• Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L) [Срок оценки: Baseline and 6 months after the procedure]
• Technical Success Rate of Genicular Artery Embolization [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 23705060
• 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. PMID 19826785
• 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. PMID 15891922
• 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. PMID 17376709
• 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. PMID 22641138
• 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. PMID 35959735
• 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. PMID 34921052
• 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. PMID 36302132

Идентификаторы

NCT: NCT07736248 · angioembolization in knee OA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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