Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis (GAE-KOA)

University of Colorado Denver (CU Denver)

Status: Begins enrollment this month

Conditions: Knee Osteoarthritis

Treatments: Procedure: GAE procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06940479

24-1048

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

GAE procedure

Other group

Description:

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

Treatment:

Procedure: GAE procedure