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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-12-08

Study Completion:2025-10-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05112926

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.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Felipe Ferreira De Souza

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Felipe Ferreira De Souza, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-08

Study Completion Date2025-10-21

Study Record Updates

Study Start Date2022-12-08

Study Completion Date2025-10-21

Terms related to this study

Additional Relevant MeSH Terms

Knee Osteoarthritis