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NCT04472091 | RECRUITING | Knee Osteoarthritis

Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
Sponsor:

Andrew Picel

Information provided by (Responsible Party):

Andrew Picel

Brief Summary:

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.

Condition or disease

Knee Osteoarthritis

Knee Pain Chronic

Knee Pain Swelling

Knee Arthritis

Arterial Occlusion

Intervention/treatment

Genicular artery embolization (GAE)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
Actual Study Start Date : 2024-06-01
Estimated Primary Completion Date : 2024-11-01
Estimated Study Completion Date : 2024-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Location Details

NCT04472091

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Locations

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94305