Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

Embosphere Microspheres

Clinical Study ID

NCT05112926

20210848

Ages 40-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 kneeosteoarthritis, which may include one or more of: a) Oral or topical NSAIDS, opioid medications, intra-articular injection ofglucocorticoids 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

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 contraindicationto embolization
Active malignancy other than non-melanomatous skin cancer
Subject is pregnant, breastfeeding, or pre-menopausal and intending to becomepregnant
Any other condition related to the subject's health and wellbeing deemedexclusionary in the opinion of the investigator

Study Design