Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Официальное название

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study

Обзор

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Вмешательства

• Процедура Genicular Artery Embolization
  Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.
• Устройство Lipiodol
  3:1 emulsion of Lipiodol to Optiray
• Процедура Simple angiogram
  Simple angiogram of the genicular arteries

Первичные конечные точки

• Reduction in KOOS pain subscore [Срок оценки: 3 months]

Вторичные конечные точки (9)

• WOMAC knee pain and dysfunction [Срок оценки: 1, 3, 6, 9, and 12 months.]
• KOOS pain and dysfunction [Срок оценки: 1, 3, 6, 9, and 12 months]
• VAS Score [Срок оценки: 0, 1, 6, 9, and 12 months]
• Crossover [Срок оценки: 3 months]
• Analgesic Reduction [Срок оценки: Baseline, 1, 3, 6, 9, and 12 months post intervention]
• Whole Knee Synovitis Scoring [Срок оценки: Baseline and 3 months]
• Perfusion [Срок оценки: Procedure]
• Knee replacement [Срок оценки: 3 months]
• Corticosteroid injection usage [Срок оценки: Baseline, 1, 3, 6, 9, and 12 months post intervention]

Критерии участия

Критерии включения

• Patients aged 40-80
• Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)
• Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale
• Knee pain > 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)
• Refusal of intra-articular corticosteroid injection

Критерии исключения

• Active malignancy
• Active infection of the affected knee
• Corticosteroid injection of the affected knee within 3 months of enrollment
• Rheumatoid arthritis or other seronegative arthropathy
• Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy
• Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
• Pregnancy or expected pregnancy
• GFR < 60 mL/min/1.73 m²
• Anaphylactic reaction to iodinated contrast
• Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS > 4
• Body weight > 400 lbs (unsafe for angiography)
• Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
• Type 1 diabetes mellitus
• Long-acting corticosteroid use within 6 months (3 months for short-acting)
• History or other evidence of acute kidney injury (AKI)
• History of reaction to contrast media, bronchial asthma, or allergic disorders
• History of hypersensitivity to gadolinium-based contrast agents (GBCAs)
• Chronic widespread generalized pain >4 on VAS pain scale, including neuropathic pain
• Major depressive disorder within 2 years before screening
• Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
• Suicide attempt or suicidal behavior within 30 days before screening
• Diagnosis of fibromyalgia
• Considering total knee replacement in the next year
• Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Публикации

• Ahmed O, Block J, Mautner K, Plancher K, Anitescu M, Isaacson A, Filippiadis DK, Epelboym Y, Bercu Z, Mitchell JW, Cristescu M, White SB, Prologo JD. Percutaneous Management of Osteoarthritis in the Knee: Proceedings from the Society of Interventional Radiology Research Consensus Panel. J Vasc Interv Radiol. 2021 Jun;32(6):919.e1-919.e6. doi: 10.1016/j.jvir.2021.03.409. Epub 2021 Mar 6. No abstrac PMID 33689834
• Ahmed O, Epelboym Y, Haskal ZJ, Okuno Y, Taslakian B, Sapoval M, Nikolic B, Golzarian J, Gaba RC, Little M, Isaacson A, Padia SA, Sze DY. Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization. J Vasc Interv Radiol. 2024 Aug;35(8):1097-1103. doi: 10.1016/j.jvir.2024.04.018. Epub 2024 Apr 27. PMID 38685470
• Dariushnia SR, Redstone EA, Heran MKS, Cramer HR Jr, Ganguli S, Gomes AS, Hogan MJ, Himes EA, Patel S, Schiro BJ, Lewis CA. Society of Interventional Radiology Quality Improvement Standards for Percutaneous Transcatheter Embolization. J Vasc Interv Radiol. 2021 Mar;32(3):476.e1-476.e33. doi: 10.1016/j.jvir.2020.10.022. No abstract available. PMID 33640083
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• Derkach M, Al Sayah F, Ohinmaa A, Svenson LW, Johnson JA. Comparative performance of the EuroQol EQ-5D-5L and the CDC healthy days measures in assessing population health. J Patient Rep Outcomes. 2022 Jun 13;6(1):64. doi: 10.1186/s41687-022-00474-7. PMID 35696002
• Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83. PMID 10201543
• Salaffi F, Leardini G, Canesi B, Mannoni A, Fioravanti A, Caporali R, Lapadula G, Punzi L; GOnorthrosis and Quality Of Life Assessment (GOQOLA). Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2003 Aug;11(8):551-60. doi: 10.1016/s1063-4584(03)00089-x. PMID 12880577
• Little MW, O'Grady A, Briggs J, Gibson M, Speirs A, Al-Rekabi A, Yoong P, Ariyanayagam T, Davies N, Tayton E, Tavares S, MacGill S, McLaren C, Harrison R. Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results. Cardiovasc Intervent Radiol. 2024 Dec;47(12):1750-1762. doi: 10.1007/s00270-024-03752-7. Epub 2024 May 31. PMID 38819473

Идентификаторы

NCT: NCT06859164 · IRB24-1674 · 1R21AR082123-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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