Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
Trial ID or NCT#
Status
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
Eligibility Criteria
- 1. Provide informed consent2. Age ≥ 40 years3. 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 injections5. Kellgren-Lawrence radiographic grade 1, 2, or 3 disease6. MRI features of active synovitis (synovial thickening and/or enhancement on MRI).7. Ineligibility or refusal of surgical management.8. Local knee tenderness
- 1. Rheumatoid or infectious arthritis2. Advanced lower extremity atherosclerosis that would limit selective angiography3. Local knee infection4. Prior knee surgery (excluding arthroscopic/meniscal interventions)5. Uncorrectable coagulopathy (INR\>1.8, platelets\<50,000/µL)6. Iodine allergy resulting in anaphylaxis7. Chronic renal insufficiency (serum creatinine \>2 mg/dL)8. Life expectancy less than 6 months
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Andrew C Picel, MD
650-736-6109
View on ClinicalTrials.gov