Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
study ends around
Principal Investigator
by Lucas Cusumano, MD

Description

Summary

Several clinical trials on genicular artery embolization (GAE) show significant clinical benefit for the majority of patients. However, a proportion of patients do not benefit from GAE, and responses vary across individual patients. Changes in metabolic activity on non-invasive imaging may correlate with improvement in symptoms of knee osteoarthritis. This study will assess changes in metabolic uptake on a hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) system in subjects undergoing GAE.

Keywords

Knee Osteoarthritis, Knee Discomfort, Knee Pain Chronic, Knee Swelling Pain, GAE, Therapeutic Embolization, Embolization

Eligibility

You can join if…

Open to people ages 40 years and up

  • Provided informed consent
  • Age ≥ 40 years
  • Ineligibility for or refusal of surgical management
  • Moderate-severe knee pain as determined by visual analog scale > 5 out of 10
  • Osteoarthritis based on X-ray. Kellgren-Lawrence score > 2 based on radiograph completed within 3 months of procedure date
  • Resistant/failed some form of conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection/hyaluronic acid joint injection) for at least 3 months
  • Able to comply with all treatments and protocol follow-up visits

You CAN'T join if...

  • Mild knee pain as determined by visual analog scale < 5 out of 10
  • OA on knee radiograph resulting in greater than 20 degree varus or valgus angulation
  • Moderate loss of kidney function, define as estimated glomerular filtration rate of less than 45 mL/min.
  • Significant arterial atherosclerosis that would limit selective angiography
  • History of fibromyalgia, autoimmune, or inflammatory disorder
  • History of any lumbar spine surgery, spine injections, or radicular pain in the extremity believed to originate from the spine
  • Allergy to iodinated contrast agents
  • Active infection or malignancy
  • Recent (within 12 months) or active cigarette use
  • Prior total or partial knee replacement in the subject knee
  • Active pregnancy
  • Uncorrectable bleeding diathesis
  • Presence of pacemakers, aneurysm clips, neurostimulators, or any other metal implant not compatible with PET/MRI

Location

  • University of California, Los Angeles
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Lucas Cusumano, MD
    HS Assistant Clinical Professor, Radiological Sciences, Medicine. Authored (or co-authored) 23 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Lucas R. Cusumano, MD
ID
NCT07494838
Study Type
Interventional
Participants
Expecting 25 study participants
Last Updated