Geniculate Artery Embolization for Osteoarthritis
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation medications, they must be safely held for the procedure and for 7 days afterward.
Is Genicular Artery Embolization (GAE) safe for humans?
Research on Genicular Artery Embolization (GAE) for knee osteoarthritis suggests it is a minimally-invasive treatment with studies evaluating its safety. These studies indicate that GAE is generally considered safe for treating knee osteoarthritis, though it is important to consult with a healthcare provider for personalized advice.12345
How is Geniculate Artery Embolization different from other treatments for knee osteoarthritis?
What is the purpose of this trial?
The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research.Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care.This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.
Research Team
Reza Talaie, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
This trial is for people with mild to moderate knee osteoarthritis who haven't improved after at least 3 months of treatments like anti-inflammatory drugs or physical therapy. They should be under 250 pounds, not planning on knee replacement surgery soon, and able to get an MRI before and after the procedure. People can't join if they're over 250 pounds, have certain heart or blood conditions, severe allergies to iodine, are pregnant, or have had certain knee surgeries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive geniculate artery embolization and standard of care or standard of care only
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Geniculate Artery Embolization
Geniculate Artery Embolization is already approved in United States, European Union for the following indications:
- Symptomatic management of knee osteoarthritis
- Treatment of chronic mild to moderate knee pain secondary to osteoarthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor