Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Not Recruiting

Trial ID: NCT04472091

Purpose

The objective of this investigation is to evaluate the safety of the geniculate artery embolization (GAE) procedure with HydroPearl® Microspheres in 30 patients with knee pain caused by osteoarthritis with 24 months follow-up. The GAE procedure is an arterial embolization procedure that blocks abnormal blood vessels caused be knee arthritis in order to evaluate the effect on knee pain.

Official Title

Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain

Stanford Investigator(s)

Andrew Picel
Andrew Picel

Clinical Associate Professor, Radiology

Eligibility


Inclusion Criteria:

   1. Provide informed consent

   2. Age ≥ 40 years

   3. Moderate to severe knee pain (VAS >40 mm)

   4. Pain refractory to 3 months of conservative treatments, including at least one of the
   following:

      - a. Anti-inflammatory medications

      - b. Physical therapy

      - c. Intra-articular injections

   5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease

   6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI).

   7. Ineligibility or refusal of surgical management.

   8. Local knee tenderness

Exclusion Criteria:

   1. Rheumatoid or infectious arthritis

   2. Advanced lower extremity atherosclerosis that would limit selective angiography

   3. Local knee infection

   4. Prior knee surgery (excluding arthroscopic/meniscal interventions)

   5. Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)

   6. Iodine allergy resulting in anaphylaxis

   7. Chronic renal insufficiency (serum creatinine >2 mg/dL)

   8. Life expectancy less than 6 months

Intervention(s):

device: Genicular artery embolization (GAE)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Andrew C Picel, MD
650-736-6109