Percutaneous Management of Osteoarthritis in the Knee: Proceedings from the Society of Interventional Radiology Research Consensus Panel.
Osman Ahmed, Joel Block, Kenneth Mautner...
https://pubmed.ncbi.nlm.nih.gov/33689834Actively Recruiting
Phase 2
Age: 40Years - 80Years
All Genders
ID06859164
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
Led by University of Chicago · Updated on 2025-05-15
50
Participants Needed
1
Research Sites
13 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
Researchers are evaluating genicular artery embolization (GAE) as a treatment to reduce pain in people with symptomatic knee osteoarthritis (KOA) who have not responded well to other treatments. This pilot randomized sham-controlled study aims to assess the feasibility of enrolling participants and to detect differences in pain relief between GAE and a sham procedure at 3 months using the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. The study also explores how psychological factors, analgesic use, and knee joint conditions may affect pain relief from GAE. Participants will be randomly assigned to one of two groups: the GAE group, where embolization is performed using a 3:1 emulsion of Lipiodol and Optiray to temporarily block blood flow in targeted knee arteries, or the sham group, where a similar procedure is done without embolization. The embolization effect lasts about 10 minutes and aims to stop blood flow in the affected vessels without harming surrounding tissues. Each group will have 20 participants. During the study, participants will undergo various assessments including pain and knee function scores (KOOS, WOMAC, VAS) at different times up to 12 months, imaging to evaluate knee inflammation and blood flow, and tracking of analgesic and corticosteroid use. The main outcome is pain reduction at 3 months. The study involves a randomized, triple-blinded design to ensure unbiased results, with follow-up evaluations to monitor safety and effectiveness over one year.
CONDITIONS
Brief Title
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Who Can Participate
Age: 40Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 40 to 80 years
- Knee pain attributed to osteoarthritis, either in one or both knees
- Osteoarthritis grade 2 to 4 on standing weight-bearing knee X-rays according to the Kellgren-Lawrence scale
- Knee pain lasting more than 6 months, not improved by non-operative treatments, with pain score of 4 or higher on Visual Analog Scale (VAS)
- Refusal to receive 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 arthropathy
- Previous surgery on the affected knee except diagnostic arthroscopy
- Osteoarthritis grade 0 or 1 on Kellgren-Lawrence scale of affected knee
- Pregnancy or expected pregnancy
- Kidney function below specified level (GFR < 60 mL/min/1.73 m²)
- Anaphylactic reaction to iodinated contrast
- Moderate to severe pain in other lower limb joints on the same side with VAS greater than 4
- Body weight over 400 pounds
- Peripheral arterial disease in treated leg (Rutherford Grade 2 or higher)
- Type 1 diabetes mellitus
- Long-acting corticosteroid use within 6 months or short-acting within 3 months
- History of acute kidney injury
- History of reactions to contrast media, asthma, or allergies
- Allergy to gadolinium-based contrast agents
- Chronic widespread pain with VAS over 4, including neuropathic pain
- Major depression diagnosed within 2 years before screening
- Severe psychiatric disorders such as schizophrenia or bipolar disorder
- Suicide attempt or behavior within 30 days before screening
- Diagnosis of fibromyalgia
- Planning total knee replacement within the next year
- Any other condition or inability that may risk safety or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with temporary embolic effect lasting roughly 10 minutes
Participants receive the genicular artery embolization procedure or a sham procedure involving angiography without embolization.
1 treatment visit (in-person)
Follow-up
Duration - 12 months
Participants are monitored for changes in knee pain and function through scheduled assessments.
Visits at baseline, 1, 3, 6, 9, and 12 months post intervention
Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Loading map...
Research Team
O
Osman Ahmed, MD
F
Faisal F Al-Qawasmi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Society of Interventional Radiology Research Reporting Standards for Genicular Artery Embolization.
Osman Ahmed, Yan Epelboym, Ziv J Haskal...
https://pubmed.ncbi.nlm.nih.gov/38685470Society of Interventional Radiology Quality Improvement Standards for Percutaneous Transcatheter Embolization.
Sean R Dariushnia, Ellen A Redstone, Manraj K S Heran...
https://pubmed.ncbi.nlm.nih.gov/33640083Significant pain variability in persons with, or at high risk of, knee osteoarthritis: preliminary investigation based on secondary analysis of cohort data.
Emma Parry, Reuben Ogollah, George Peat
https://pubmed.ncbi.nlm.nih.gov/28196504Comparative performance of the EuroQol EQ-5D-5L and the CDC healthy days measures in assessing population health.
Maryna Derkach, Fatima Al Sayah, Arto Ohinmaa...
https://pubmed.ncbi.nlm.nih.gov/35696002The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network.
J M Binkley, P W Stratford, S A Lott...
https://pubmed.ncbi.nlm.nih.gov/10201543Reliability and validity of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index in Italian patients with osteoarthritis of the knee.
F Salaffi, G Leardini, B Canesi...
https://pubmed.ncbi.nlm.nih.gov/12880577Genicular Artery embolisation in Patients with Osteoarthritis of the Knee (GENESIS) Using Permanent Microspheres: Long-Term Results.
M W Little, A O'Grady, J Briggs...
https://pubmed.ncbi.nlm.nih.gov/38819473Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis.
Siddharth A Padia, Scott Genshaft, Gideon Blumstein...
https://pubmed.ncbi.nlm.nih.gov/34703964Genicular artery embolization for knee osteoarthritis: Results of the LipioJoint-1 trial.
Marc Sapoval, Charles Querub, Helena Pereira...
https://pubmed.ncbi.nlm.nih.gov/38102013