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New treatment option for Knee Osteoarthritis
Official title Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06859164
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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...
- Refusal of intra-articular corticosteroid injection
You likely can't join 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)...
- Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
See the full eligibility 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...
- Refusal of intra-articular corticosteroid injection
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.