Clinical trial NCT06859164: Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Official title: Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Knee Osteoarthritis (OA)
Keywords: Osteoarthritis
Knee pain
MSK pain
Musculoskeletal Pain
Osteoarthritis of the knee
GAE
Genicular artery embolization
Geniculate artery embolization
MSK embolization
Musculoskeletal Embolization
Embolization
Musculoskeletal
Temporary Embolization
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2025-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Reduction in KOOS pain subscore
timeFrame: 3 months
Secondary outcomes:
measure: WOMAC knee pain and dysfunction
timeFrame: 1, 3, 6, 9, and 12 months.
measure: KOOS pain and dysfunction
timeFrame: 1, 3, 6, 9, and 12 months
measure: VAS Score
timeFrame: 0, 1, 6, 9, and 12 months
measure: Crossover
timeFrame: 3 months
measure: Analgesic Reduction
timeFrame: Baseline, 1, 3, 6, 9, and 12 months post intervention
measure: Whole Knee Synovitis Scoring
timeFrame: Baseline and 3 months
measure: Perfusion
timeFrame: Procedure
measure: Knee replacement
timeFrame: 3 months
measure: Corticosteroid injection usage
timeFrame: Baseline, 1, 3, 6, 9, and 12 months post intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago Department of Radiology
name: Osman Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 abstract available.
citation: 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.
citation: 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.
citation: Parry E, Ogollah R, Peat G. Significant pain variability in persons with, or at high risk of, knee osteoarthritis: preliminary investigation based on secondary analysis of cohort data. BMC Musculoskelet Disord. 2017 Feb 14;18(1):80. doi: 10.1186/s12891-017-1434-3.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Padia SA, Genshaft S, Blumstein G, Plotnik A, Kim GHJ, Gilbert SJ, Lauko K, Stavrakis AI. Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. JB JS Open Access. 2021 Oct 21;6(4):e21.00085. doi: 10.2106/JBJS.OA.21.00085. eCollection 2021 Oct-Dec.
citation: Sapoval M, Querub C, Pereira H, Pellerin O, Boeken T, Di Gaeta A, Ahmar MA, Lefevre-Colau MM, Nguyen C, Daste C, Lacroix M, Laredo JD, Sabatier B, Martelli N, Chatellier G, Dean C, Rannou F. Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial. Diagn Interv Imaging. 2024 Apr;105(4):144-150. doi: 10.1016/j.diii.2023.12.003. Epub 2023 Dec 14.
citation: Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.
citation: Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
citation: GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.