Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis

NCT06940479 | Recruiting

• 1 other identifier: 24-1048
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Measure changes in KOOS score and synovial fluid biomarkers

  To estimate the correlation between objective changes in synovial fluid biomarkers (IL-6, VEGF and MCP-1) and changes in subjective symptomatic response (KOOS) 3 months after treatment of knee osteoarthritis with GAE. KOOS is a validated knee osteoarthritis scoring system that involves five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions). Trials demonstrate maximum symptomatic response to GAE at 3 months, and sustained improvement for at least 1-2 years. Improvement in KOOS reflects symptomatic response to treatment. This will determine whether changes in the local inflammatory environment in the knee synovium correlate with symptomatic response to GAE. This would also help elucidate whether the mechanism of action of GAE is likely attributable to inflammation.

  3 months after GAE procedure

Secondary Outcomes (6)

• Measure changes in synovial enhancement with contrast-enhanced MRI according to WORMS synovitis scores

  3 months after GAE procedure

• Measure changes in synovial enhancement with contrast-enhanced MRI according to MOST grading system

  3 months after GAE procedure

• Measure changes in VAS scores

  12 months after procedure

• Measure changes in KOOS scores

  12 months after procedure

• Estimate correlation between objective measures to symptomatic response

  3 months after GAE procedure

Study Arms (1)

GAE procedure

OTHER

Participants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure.

Procedure: GAE procedure

Interventions

GAE procedure PROCEDURE

Genicular artery embolization

GAE procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Leigh Casadaban, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shireen Shikak, BS

CONTACT

720.848.6618; shireen.shikak@cuanschutz.edu

Tricia Luna, MS, RN

CONTACT

720.848.6610; patricia.luna@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)