Knee joint fluid changes after genicular artery embolization for osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.