Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain
Key facts
- Who runs it
- Andrew Picel
- Where
- Palo Alto, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 15 Jan 2025
- Ended
- 1 Nov 2026
- Type of study
- Interventional
- Treatments tested
- Genicular artery embolization (GAE)
- Record updated
- 24 February 2025
- Why it stopped
- No Insurance Coverage
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior knee surgery (excluding arthroscopic/meniscal interventions)
- Local knee infection
- Iodine allergy resulting in anaphylaxis
- Uncorrectable coagulopathy (INR>1.8, platelets<50,000/µL)
- Chronic renal insufficiency (serum creatinine >2 mg/dL)
- Rheumatoid or infectious arthritis
- Advanced lower extremity atherosclerosis that would limit selective angiography
- Life expectancy less than 6 months
Where in United States
- Stanford UniversityPalo Alto, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Genicular artery embolizationTreatment being tested
Participants will undergo the genicular artery embolization (GAE) procedure for the treatment of moderate to severe knee osteoarthritis. A total of 30 patients will be enrolled in the single treatment arm of the study. The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, patients will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ). Following treatment, patients will undergo follow-up at 1, 6, 12, and 24 months post GAE.
Treatment: Genicular artery embolization (GAE)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Genicular Artery Embolization for the Treatment of Moderate to Severe Osteoarthritic Knee Pain
- Record updated
- 24 February 2025