Status:

WITHDRAWN

Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

Lead Sponsor:

Andrew Picel

Conditions:

Knee Osteoarthritis

Knee Pain Chronic

Eligibility:

All Genders

40+ years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • Provide informed consent
  • Age ≥ 40 years
  • Moderate to severe knee pain (VAS \>40 mm)
  • 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
  • Kellgren-Lawrence radiographic grade 1, 2, or 3 disease
  • MRI features of active synovitis (synovial thickening and/or enhancement on MRI).
  • Ineligibility or refusal of surgical management.
  • Local knee tenderness

Exclusion

  • Rheumatoid or infectious arthritis
  • Advanced lower extremity atherosclerosis that would limit selective angiography
  • Local knee infection
  • Prior knee surgery (excluding arthroscopic/meniscal interventions)
  • Uncorrectable coagulopathy (INR\>1.8, platelets\<50,000/µL)
  • Iodine allergy resulting in anaphylaxis
  • Chronic renal insufficiency (serum creatinine \>2 mg/dL)
  • Life expectancy less than 6 months

Key Trial Info

Start Date :

January 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2026

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04472091

Start Date

January 15 2025

End Date

November 1 2026

Last Update

February 24 2025

Active Locations (1)

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1

Stanford University

Palo Alto, California, United States, 94305