RecruitingPhase 2NCT06859164

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

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

Sponsor

University of Chicago

Enrollment

50 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis Knee Osteoarthritis (Knee OA)

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

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria24

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