Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Eligible age
40–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Chicago
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
Where it's recruiting
Chicago
Source: ClinicalTrials.gov · NCT06859164 · last updated 2025-05-15