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

NCT05112926 | Completed FDA Device

• 1 other identifier: 20210848
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change in knee pain as assessed by the WOMAC

  Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain index assesses participants' pain on a scale ranging from 0 (none) to 4 (extreme). The pain subscale consists of 5 items and total scores can range from 0-20, with larger scores indicating greater pain.

  Baseline, 24 Weeks (Post Embolization Surgery)

• Incidence of treatment related adverse events

  Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician

  Up to 4 weeks (Post Embolization Surgery)

Secondary Outcomes (5)

• Change in knee pain as assessed by VAS

  Baseline, up to 52 weeks (Post Embolization Surgery)

• Change in knee pain

  Baseline, up to 52 weeks (Post Embolization Surgery)

• Incidence of adverse events

  Up to 52 weeks (Post Embolization Surgery)

• WORMS Score for Synovitis

  Baseline, up to 52 weeks (Post Embolization Surgery)

• Kellgren-Lawrence Grade

  Baseline, up to 52 weeks (Post Embolization Surgery)

Study Arms (1)

Embosphere Microspheres group

EXPERIMENTAL

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.

Device: Embosphere Microspheres

Interventions

Embosphere Microspheres DEVICE

Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.

Embosphere Microspheres group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Felipe Ferreira De Souza

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 9, 2021
• Study Start: December 8, 2022
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)