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Procedure
Geniculate Artery Embolization for the Treatment of Knee Osteoarthritis
N/A
Recruiting
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient not a surgical candidate or declines surgical management
Age > 40 years
Must not have
Local infection and inflammatory arthritis
ECOG grade > 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3 and 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the effectiveness of GAE in reducing knee pain in patients with OA. Osteoarthritis is a degenerative joint disease that can cause pain & disability, especially in older Canadians. This trial will test a minimally invasive alternative treatment to reduce knee pain.
Who is the study for?
This trial is for individuals over 40 with knee osteoarthritis who haven't found relief from pain after at least 3 months of conservative treatments, such as medication or injections. It's aimed at those who are not candidates for surgery or choose not to undergo it.
What is being tested?
The trial is testing Geniculate Artery Embolization (GAE), a minimally invasive procedure designed to reduce inflammation and pain in the knee by disrupting blood vessel growth and nerve fiber development associated with osteoarthritis.
What are the potential side effects?
While GAE has a low risk of complications, potential side effects may include minor bruising or soreness at the catheter insertion site, temporary numbness, allergic reaction to contrast materials used during the procedure, and rare cases of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot or choose not to have surgery for my condition.
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I am over 40 years old.
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My X-rays show arthritis in the knee that hurts.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a local infection and inflammation in my joints.
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I need help with my daily activities due to my health condition.
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I have severe pain in my lower limb, not related to my knee.
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My kidney function is low, with an eGFR below 45.
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My knee pain is due to severe arthritis.
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I have a condition or test results that increase my risk of bleeding.
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I have been diagnosed with cancer.
Select...
I have had knee surgery before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3 and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Reduction
Secondary study objectives
Pain medication required
Pain, stiffness and physical function
Procedure related complications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Geniculate Artery Embolization armExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Geniculate Artery Embolization
2018
N/A
~50
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
811 Previous Clinical Trials
892,765 Total Patients Enrolled
14 Trials studying Osteoarthritis
1,014 Patients Enrolled for Osteoarthritis