Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis (SHAM-PAIN)

The University of Chicago

Status and phase: Enrolling; Phase 2

Conditions: Knee Osteoarthritis (OA); Knee Osteoarthritis (Knee OA); Knee Osteoarthritis

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06859164

1R21AR082123-01A1 (U.S. NIH Grant/Contract)

IRB24-1674

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

GAE Arm

Experimental group

Description:

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.

Treatment:

Procedure: Simple angiogram

Device: Lipiodol

Procedure: Genicular Artery Embolization

Sham Arm

Sham Comparator group

Description:

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.

Treatment:

Procedure: Simple angiogram