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

Description

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.

Conditions

Knee Osteoarthritis

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Study Overview

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Study Details

Study overview

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.

Prospective, Single Arm Investigation to Assess Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

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

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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
  • * 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

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shivank Bhatia,

Shivank Bhatia, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2024-12-01