Recruiting

GAE

Sponsor:

University of Colorado, Denver

Code:

NCT06940479

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GAE procedure

Study Details

Brief summary:

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:

  • Have a contrast enhanced MRI before and after the procedure
  • Complete performance-based measures before and after the procedure
  • Complete questionnaires before and after the procedure

Conditions

Knee Osteoarthritis

Study ID

NCT06940479

Start date

Jul 16, 2025

Status verified date

Mar, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: GAE procedure

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

Interventions

GAE procedure

Genicular artery embolization

Primary outcome measure

  • Measure changes in KOOS score and synovial fluid biomarkers [ Time Frame: 3 months after GAE procedure ]

Central Contacts and Locations

Central contacts

Shireen Shikak, BS

720.848.6618shireen.shikak@cuanschutz.edu

Tricia Luna, MS, RN

720.848.6610patricia.luna@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Shireen Shikak, BS

720-848-6767

Principal Investigator:

Leigh Casadaban, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-03-24.