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

Last updated: May 5, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

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

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Embosphere Microspheres
Phase:
Study Start date:
December 08, 2022
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

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