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

Shivank Bhatia

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Embosphere Microspheres

Study type: Interventional

Funder types: Other

Identifiers

NCT05112926

20210848

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Embosphere Microspheres group

Experimental group

Description:

Participants in this group who are receiving standard of care (SOC) embolization surgery for the treatment of moderate to severe knee osteoarthritis will receive the Embospheres Microspheres during scheduled SOC surgery.

Treatment:

Device: Embosphere Microspheres