Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The purpose of this research study is to evaluate the effectiveness and safety of a permanent
embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment
of moderate to severe knee osteoarthritis.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- Subject has signed informed consent
- Subject is age 40-80
- Subject is able to have an MRI
- Minimum of prior 12 weeks of failed response to conservative therapy for knee
osteoarthritis, which may include one or more of:
a) Oral or topical NSAIDS, opioid medications, intra-articular injection of
glucocorticoids or hyaluronic acid, physical therapy.
- Localized tenderness in anterior knee area
- Kellgren-Lawrence grade 1, 2, or 3 as assessed by weight-bearing knee radiographs
- Synovitis present as assessed by WORMS
- VAS >50 mm
- WOMAC score >30
Exclusion Criteria:
- Rheumatoid arthritis
- Local infection of the target knee(s)
- Kellgren-Lawrence grade >3
- Osteonecrosis evident by MRI
- Prior knee arthroplasty
- Allergy to iodinated contrast agents that cannot be managed by prophylaxis
- Hypersensitivity to gelatin products
- Any known condition that limits catheter-based intervention or is a contraindication
to embolization
- Active malignancy other than non-melanomatous skin cancer
- Subject is pregnant, breastfeeding, or pre-menopausal and intending to become pregnant
- Any other condition related to the subject's health and wellbeing deemed exclusionary
in the opinion of the investigator