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NCT05112926 | RECRUITING | 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
Sponsor:

Shivank Bhatia

Information provided by (Responsible Party):

Shivank Bhatia

Brief 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.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Embosphere Microspheres

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2022-12-08
Estimated Primary Completion Date : 2024-12-01
Estimated Study Completion Date : 2024-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known Moderate to Severe Knee Osteoarthritis

Location Details

NCT05112926

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How to Participate

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Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136