Effectiveness and Safety of Embosphere Microspheres for Embolization of the Geniculate Artery for the Treatment of Pain With Known 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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Embosphere Microspheres

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lia Quezada; Phone Number: 305-243-2210; Email: lquezada@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Shivank Bhatia
      • Contact: Lia Quezada; Phone Number: 305-243-2210; Email: lquezada@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embosphere Microspheres group; 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; Embosphere Microspheres are 100-300μm small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin used for embolization of geniculate artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee pain as assessed by VAS	Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain	Baseline, up to 52 weeks (Post Embolization Surgery)
Change in knee pain	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, up to 52 weeks (Post Embolization Surgery)
Incidence of adverse events	Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician	Up to 52 weeks (Post Embolization Surgery)
WORMS Score for Synovitis	Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems	Baseline, up to 52 weeks (Post Embolization Surgery)
Kellgren-Lawrence Grade	As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)	Baseline, up to 52 weeks (Post Embolization Surgery)

Collaborators and Investigators

• Sponsor: Shivank Bhatia
• Investigators: Principal Investigator: Shivank Bhatia, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 20210848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes