Recruiting

GAE-KOAGenicular Artery Embolization for Knee Osteoarthritis Symptoms and Inflammation

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What is being tested

GAE procedure

Procedure
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Study ContactShireen Shikak, BSMore contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 16, 2025

Actual date on which the first participant was enrolled.

This clinical trial is investigating whether a procedure called genicular artery embolization (GAE) can help reduce knee pain and inflammation in adults suffering from knee osteoarthritis. Osteoarthritis is a common joint condition that causes pain and swelling, making movement difficult. The study focuses on understanding if this procedure, which targets specific blood vessels in the knee, can provide relief from symptoms and improve quality of life for those affected by this condition. Participants in the study will undergo the GAE procedure and will be monitored to assess changes in their knee condition. This involves taking samples of the joint fluid and conducting MRI scans before and after the procedure to observe any changes in inflammation. Participants will also complete physical performance tests and fill out questionnaires to track their pain levels and mobility. By comparing results from before and after the procedure, researchers aim to determine the effectiveness of GAE in treating knee osteoarthritis.

Official TitleGenicular Artery Embolization for Knee Osteoarthritis: Evaluation of the Correlation Between Subjective Symptom Response and Objective Measures of Inflammation
NCT06940479
Principal SponsorUniversity of Colorado, Denver
Study ContactShireen Shikak, BSMore contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

7 inclusion criteria required to participate
Age >= 18 years
Planned to undergo genicular artery embolization to treat knee osteoarthritis
Osteoarthritis on knee radiograph (Kellgren-Lawrence score 1-3) within the last 6 months
Persistent moderate to severe knee pain (visual analog scale [VAS] > 3) for at least 6 months
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15 exclusion criteria prevent from participating
Coagulation disturbances not normalized by medical treatment (INR > 1.8 and platelets < 50 x 10^9/L)
Receiving medications for anticoagulation which cannot safely be held for the procedure (e.g ASA for 5 days, Lovenox for 24 hours, Eliquis for 4-6 days depending on creatinine clearance
Allergy to iodinated contrast agents not responsive to steroid premedication regimen
Active knee joint infection
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Participants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Colorado Anschutz Medical Campus

Aurora, United StatesOpen University of Colorado Anschutz Medical Campus in Google Maps
Recruiting
One Study Center