Genicular Artery Embolization to Reduce Pain Associated With Unilateral Mild to Moderate Osteoarthritis
Completed · Not applicable
Conditions studied: Knee Osteoarthritis
In brief
The goal of this study is to perform a feasibility study to show the effectiveness of the genicular artery embolization procedure in reducing bilateral or unilateral osteoarthritic knee pain at 12 months as measured by WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score, Knee Injury and Osteoarthritis Outcome (KOOS) score, and Oswestry Disability Index.
Key facts
- Study ID
- NCT04592562
- Run by
- University of Chicago
- People needed
- 5
- Starts
- 2021-09-22
- Expected to finish
- 2024-05-28
- Last updated by the study team
- 2024-11-04
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- We intend to include patients who meet the following criteria in the study:
- Patients aged 40-80
- Bilateral or Unilateral knee pain attributed to osteoarthritis
- Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
- Knee pain >6 months refractory to conservative medical management (NSAIDs, paracetamol, intra-articular injections, physiotherapy/exercise, weight loss, etc.)
You may not qualify if…
- We plan to exclude patients who meet any of the following criteria:
- Active malignancy
- Active infection of the affected knee
- Platelets <50,000
- INR >1.8 (unless on anticoagulation that can be reversed)
- Corticosteroid injection of the affected knee within 3 months
- Rheumatoid arthritis or other seronegative arthropathy
- Previous surgery (excluding arthroscopy) of the affected knee
- Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
- Pregnancy or expected pregnancy
- GFR <30
- Anaphylactic reaction to iodinated contrast
- Moderate to severe pain in other lower limb joints
- Body weight >400 lbs. (Procedure table weight limit)
- BMI >50
- Patients at high risk for contrast nephropathy
Where it is running
- University of Chicago Hospital — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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