Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Last updated: February 20, 2025
Sponsor: Andrew Picel
Overall Status: Trial Not Available

Phase

N/A

Condition

Osteoarthritis

Vascular Diseases

Knee Injuries

Treatment

Genicular artery embolization (GAE)

Clinical Study ID

NCT04472091
57046
IDE G200111
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofthe following:

  • a. Anti-inflammatory medications

  • b. Physical therapy

  • c. Intra-articular injections

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

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

  3. Ineligibility or refusal of surgical management.

  4. Local knee tenderness

Exclusion

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

Study Design

Treatment Group(s): 1
Primary Treatment: Genicular artery embolization (GAE)
Phase:
Study Start date:
January 15, 2025
Estimated Completion Date:
November 01, 2026

Connect with a study center

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

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