An interventional study of GAE procedure in Knee Osteoarthritis, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if genicular artery embolization (GAE) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. The main question it aims to answer is:
- Does the GAE procedure improve knee pain and decrease inflammation?
Researchers will compare synovial fluid samples taken from the knee before and after the procedure.
Participants will:
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 46 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure.
Procedure: GAE procedure
Genicular artery embolization
Measure changes in KOOS score and synovial fluid biomarkers
To estimate the correlation between objective changes in synovial fluid biomarkers (IL-6, VEGF and MCP-1) and changes in subjective symptomatic response (KOOS) 3 months after treatment of knee osteoarthritis with GAE. KOOS is a validated knee osteoarthritis scoring system that involves five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions). Trials demonstrate maximum symptomatic response to GAE at 3 months, and sustained improvement for at least 1-2 years. Improvement in KOOS reflects symptomatic response to treatment. This will determine whether changes in the local inflammatory environment in the knee synovium correlate with symptomatic response to GAE. This would also help elucidate whether the mechanism of action of GAE is likely attributable to inflammation.
Time frame: 3 months after GAE procedure
Measure changes in synovial enhancement with contrast-enhanced MRI according to WORMS synovitis scores
The WORMS scoring system is a semi-quantitative assessment of 14 features found on knee MRI. The WORMS synovitis subscale is scored based on the distension of the joint capsule and is graded from 0 to 3 in terms of the estimated maximal distention of the synovial cavity with 0=normal, grade 1=\<33% of maximum potential distention grade 2=33%-66% of maximum potential distention and grade 3=\>66% of maximum potential distention WORMS will be used to determine changes in synovial fluid biomarkers pre-treatment and 3 months after treatment of knee osteoarthritis with GAE.
Time frame: 3 months after GAE procedure
Measure changes in synovial enhancement with contrast-enhanced MRI according to MOST grading system
The MRI will also be evaluated using the Multicenter Osteoarthritis Study grading system for synovitis. The Multicenter Osteoarthritis Study (MOST) grading system for knee synovitis is an alternative to the WORMS synovitis score and incorporates a larger range of grading. The higher the score, the worse the synovial inflammation. The scoring ranges from 0-13, with 0-4 for normal or equivocal synovitis, 5-8 for mild synovitis, 9-12 for moderate synovitis, and 13 or greater for severe synovitis.
Time frame: 3 months after GAE procedure
Measure changes in VAS scores
Patients will be given VAS questionnaires to give subjective responses to changes in pain levels and its effect on activities of daily living. VAS is calculated by scoring pain level between 0-100. This is asked verbally "How would you rate your pain in the affected knee?" These questionnaires will be given at time points: screening, 1 month after GAE, 3 months, 6 months and 12 months.
Time frame: 12 months after procedure
Measure changes in KOOS scores
The Knee Injury and Osteoarthritis Outcome Score involves five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions). Patients will be given KOOS questionnaires to give subjective responses to changes in pain levels and its effect on activities of daily living. These questionnaires will be given at time points: screening, 1 month after GAE, 3 months, 6 months and 12 months.
Time frame: 12 months after procedure
Estimate correlation between objective measures to symptomatic response
To estimate the correlation between objective measures of knee pain or inflammation (performance-based measures, contrast-enhanced MRI synovitis scores) to symptomatic response (KOOS) 3 months after treatment of knee osteoarthritis with GAE. This may provide additional assurance in the form of objective measures of response in a disease that is known to have a strong placebo effect.
Time frame: 3 months after GAE procedure
Estimate correlation between changes in a larger set of synovial fluid biomarkers and changes in subjective scores
To estimate the correlation between changes in a larger set of synovial fluid biomarkers (54markers across inflammation, chemotaxis, angiogenesis, and immune system regulation pathways) and changes in subjective scores (KOOS) 3 months after treatment. This will further develop the interrogation of which microenvironment pathways in the knee synovium correlate with symptomatic response to GAE.
Time frame: 3 months after GAE procedure
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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University of Colorado, Denver