NCT06940479 Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
| NCT ID | NCT06940479 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2025-07-16 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Leigh Casadaban, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06940479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06940479 currently recruiting?
Yes, NCT06940479 is actively recruiting participants. Contact the research team at shireen.shikak@cuanschutz.edu for enrollment information.
Where is the NCT06940479 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06940479 clinical trial?
NCT06940479 is sponsored by University of Colorado, Denver. The principal investigator is Leigh Casadaban, MD at University of Colorado, Denver. The trial plans to enroll 46 participants.