Clinical trial NCT06940479: Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
Official title: Genicular Artery Embolization for Knee Osteoarthritis: Evaluation of the Correlation Between Subjective Symptom Response and Objective Measures of Inflammation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Measure changes in KOOS score and synovial fluid biomarkers
timeFrame: 3 months after GAE procedure
Secondary outcomes:
measure: Measure changes in synovial enhancement with contrast-enhanced MRI according to WORMS synovitis scores
timeFrame: 3 months after GAE procedure
measure: Measure changes in synovial enhancement with contrast-enhanced MRI according to MOST grading system
timeFrame: 3 months after GAE procedure
measure: Measure changes in VAS scores
timeFrame: 12 months after procedure
measure: Measure changes in KOOS scores
timeFrame: 12 months after procedure
measure: Estimate correlation between objective measures to symptomatic response
timeFrame: 3 months after GAE procedure
measure: Estimate correlation between changes in a larger set of synovial fluid biomarkers and changes in subjective scores
timeFrame: 3 months after GAE procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Leigh Casadaban, MD
role: PRINCIPAL_INVESTIGATOR
References: