Knee joint fluid changes after genicular artery embolization for osteoarthritis
Genicular Artery Embolization for Knee Osteoarthritis: Evaluation of the Correlation Between Subjective Symptom Response and Objective Measures of Inflammation
This project will test whether genicular artery embolization (GAE) can reduce knee pain and joint inflammation in adults with knee osteoarthritis by comparing knee fluid samples, MRI scans, performance tests, and symptoms before and after the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06940479 on ClinicalTrials.gov |
What this trial studies
Adults with radiographic knee osteoarthritis who are scheduled for genicular artery embolization will have synovial fluid collected, contrast-enhanced MRI scans, performance-based measures, and questionnaires before and after the procedure. Researchers will compare inflammatory markers and other changes in the synovial fluid alongside imaging and clinical outcomes to see if GAE corresponds with reduced inflammation and pain. The intervention is a single-site, interventional procedure performed at the University of Colorado Anschutz Medical Campus. Follow-up measures are taken after the procedure to assess short-term biological and symptomatic changes.
Who should consider this trial
Good fit: Adults aged 18 or older with knee osteoarthritis (Kellgren-Lawrence grade 1–3), persistent moderate-to-severe pain despite conservative therapy, BMI under 35, and a planned GAE procedure are ideal candidates.
Not a fit: Patients with very advanced osteoarthritis (KL grade 4), active knee infection, uncorrected bleeding disorders, or who cannot safely stop anticoagulation are unlikely to benefit from this procedure or participation.
Why it matters
Potential benefit: If successful, GAE could lower knee pain and joint inflammation and potentially delay or reduce the need for more invasive surgery.
How similar studies have performed: Small case series and early clinical reports of GAE have reported pain relief, but pre- and post-procedure synovial fluid comparisons are a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Leigh Casadaban, MD — University of Colorado, Denver
- Study coordinator: Shireen Shikak, BS
- Email: shireen.shikak@cuanschutz.edu
- Phone: 720.848.6618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.