Recruiting
Phase 2

Genicular Artery Embolization

Sponsor:

University of Chicago

Code:

NCT06859164

Conditions

Knee Osteoarthritis

Knee Osteoarthritis (Knee OA)

Knee Osteoarthritis (OA)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Genicular Artery Embolization

Lipiodol

Simple angiogram

Study Details

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)

Study ID

NCT06859164

Start date

May 1, 2025

Status verified date

May, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GAE Arm

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.

sham comparator: Sham Arm

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.

Interventions

Genicular Artery Embolization

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

Lipiodol

3:1 emulsion of Lipiodol to Optiray

Simple angiogram

Simple angiogram of the genicular arteries

Primary outcome measure

  • Reduction in KOOS pain subscore [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Osman Ahmed, MD

8478124513OAhmed@bsd.uchicago.edu

Faisal F Al-Qawasmi

t-9falqa@uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Osman Ahmed, MD

847-812-4513OAhmed@bsd.uchicago.edu

Faisal F Al-Qawasmi

t-9falqa@uchicago.edu

Principal Investigator:

Osman Ahmed, MD

More Information

Sponsor

University of Chicago

Last update posted

May 15, 2025

Last verified

May, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-05-15.