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

NCT06859164 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: IRB24-16741R21AR082123-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Reduction in KOOS pain subscore

  Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.

  3 months

Secondary Outcomes (9)

• WOMAC knee pain and dysfunction

  1, 3, 6, 9, and 12 months.

• KOOS pain and dysfunction

  1, 3, 6, 9, and 12 months

• VAS Score

  0, 1, 6, 9, and 12 months

• Crossover

  3 months

• Analgesic Reduction

  Baseline, 1, 3, 6, 9, and 12 months post intervention

Study Arms (2)

GAE Arm

EXPERIMENTAL

In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.

Procedure: Genicular Artery Embolization; Device: Lipiodol; Procedure: Simple angiogram

Sham Arm

SHAM COMPARATOR

Participants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm.

Procedure: Simple angiogram

Interventions

Genicular Artery Embolization PROCEDURE

Embolization of genicular arteries that demonstrate neoangiogenesis or blush on angiogram.

Also known as: GAE, Geniculate Artery Embolization

GAE Arm

Lipiodol DEVICE

3:1 emulsion of Lipiodol to Optiray

GAE Arm

Simple angiogram PROCEDURE

Simple angiogram of the genicular arteries

GAE Arm; Sham Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 33689834 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28196504 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34703964 BACKGROUND

• 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.

  PMID: 38102013 BACKGROUND

• 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.

  PMID: 35317254 BACKGROUND

• Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

  PMID: 24024017 BACKGROUND

• 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.

  PMID: 37675071 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Osman Ahmed, MD

  University of Chicago Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osman Ahmed, MD

CONTACT

8478124513; OAhmed@bsd.uchicago.edu

Faisal F Al-Qawasmi

CONTACT

t-9falqa@uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 5, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)