Status:
RECRUITING
Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
Lead Sponsor:
University of Colorado, Denver
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 answ...
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
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06940479
Start Date
July 16 2025
End Date
July 1 2028
Last Update
November 18 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045