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GAE for Knee Osteoarthritis Study

This study is looking at whether a procedure called genicular artery embolization (GAE) can help reduce knee pain and inflammation in adults with knee osteoarthritis. Researchers want to see if GAE improves pain and inflammation by comparing fluid samples from the knee before and after the procedure. You might be able to join if you are at least 18 years old, have knee osteoarthritis (Kellgren-Lawrence score 1-3), have had moderate to severe knee pain for at least 6 months, and haven't found relief from other treatments. The study aims to enroll 46 participants.

Study design
This is an interventional study planning to enroll 46 participants. It is not specified if it is randomized or blinded.
What's involved
You would have a contrast-enhanced MRI, complete performance-based measures, and fill out questionnaires before and after the GAE procedure.
Compensation
Not stated in the trial record.
Follow-up
Changes in knee pain and synovial fluid biomarkers will be measured at 3 months after the GAE procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06940479

Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis

Recruiting
NAAges 18+InterventionalTreatment
University of Colorado, Denver
~46 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:GAE procedure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure changes in KOOS score and synovial fluid biomarkers
Measured over 3 months after GAE procedure

Conditions

Knee Osteoarthritis

Explore related trials

Osteoarthritis of knee

NCT06940479

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Colorado Anschutz Medical Campus

    Aurora, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Leigh Casadaban, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Shireen Shikak, BS
[email protected]
720.848.6618
Email the study team

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Eligibility criteria

Inclusion

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
Pain refractory or intolerant to conservative therapies (e.g. analgesia, exercise, weight-loss, joint injections, physical therapy)
BMI \< 35 kg / m2
Stated willingness to comply with study procedures and availability for the duration of the study

Exclusion

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
Acute knee injury with surgical indication (MRI evidence of acute fracture or ligamentous injury of the knee)
Prior total or partial knee replacement in the subject knee
Intra-articular steroid injection within 2 months
Untreated lower extremity vascular arterial disease
Untreated venous insufficiency
Presence of medical condition with life expectancy less than 6 months
Patients who have undergone previous lower extremity embolization
Patients with renal insufficiency based on an estimated GFR\<45 ml/min who are not already on hemodialysis
Patients who are pregnant or intend to become pregnant within 6 months of the procedure
American Society of Anesthesiologists classification \> 3
Less than 3 mm of synovial fluid in the lateral suprapatellar recess on MRI or US

What this trial measures

  • Measure changes in KOOS score and synovial fluid biomarkers3 months after GAE procedure

    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.