Actively Recruiting
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Led by University of Chicago · Updated on 2025-05-15
50
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40-80
- Knee pain in one or both knees due to osteoarthritis
- Osteoarthritis grade 2-4 on standing weight-bearing knee X-rays using Kellgren-Lawrence scale
- Knee pain lasting more than 6 months and not improved by conservative treatments
- Pain score of 4 or higher on Visual Analog Scale
- Refusal to have intra-articular corticosteroid injection
You will not qualify if you...
- Active cancer
- Active infection in the affected knee
- Corticosteroid injection in affected knee within 3 months before enrollment
- Rheumatoid arthritis or other seronegative arthritis
- Previous knee surgery except diagnostic arthroscopy
- Osteoarthritis grade 0-1 on affected knee X-rays
- Pregnancy or expected pregnancy
- Kidney function with GFR less than 60 mL/min/1.73 m�
- Anaphylactic reaction to iodinated contrast
- Moderate to severe pain in other lower limb joints with pain score above 4
- Body weight over 400 lbs
- Peripheral arterial disease in treated leg (Rutherford Grade 2 or higher)
- Type 1 diabetes mellitus
- Use of long-acting corticosteroids within 6 months or short-acting within 3 months
- History of acute kidney injury
- Allergic reaction to contrast agents or asthma
- Hypersensitivity to gadolinium-based contrast agents
- Generalized widespread pain over 4 on pain scale, including neuropathic pain
- Major depressive disorder within 2 years
- Severe psychiatric disorders like schizophrenia or bipolar disorder
- Suicide attempt or behavior within 30 days
- Fibromyalgia diagnosis
- Planning total knee replacement within the next year
- Any other condition or unwillingness that may affect safety or study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
O
Osman Ahmed, MD
CONTACT
F
Faisal F Al-Qawasmi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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