Genicular Artery Embolization (GAE) for Osteoarthritic Knee Pain

  • STATUS
    Recruiting
  • End date
    Nov 1, 2024
  • participants needed
    30
  • sponsor
    Andrew Picel
Updated on 18 May 2022
tenderness
conservative management
knee pain
knee arthritis

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.

Details
Condition Knee Osteoarthritis, Knee Pain Chronic, Knee Pain Swelling, Knee Arthritis, Arterial Occlusion
Treatment Genicular artery embolization (GAE)
Clinical Study IdentifierNCT04472091
SponsorAndrew Picel
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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