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Completed

NCT Number: NCT05112926

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in knee pain as assessed by the WOMAC

    Time frame: Baseline, 24 Weeks (Post Embolization Surgery)

    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.

  2. Incidence of treatment related adverse events

    Time frame: Up to 4 weeks (Post Embolization Surgery)

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

Secondary outcomes

  1. Change in knee pain as assessed by VAS

    Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)

    Visual Analog Scale (VAS) has a total score ranging from 0-10 with the higher score indicating greater pain

  2. Change in knee pain

    Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)

    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.

  3. Incidence of adverse events

    Time frame: Up to 52 weeks (Post Embolization Surgery)

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

  4. WORMS Score for Synovitis

    Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)

    Whole-Organ Magnetic Resonance Imaging Score (WORMS) has a score ranging from zero representing no knee problems and 332 representing knee problems

  5. Kellgren-Lawrence Grade

    Time frame: Baseline, up to 52 weeks (Post Embolization Surgery)

    As assessed by X-Ray. Radiograph imaging graded on scale 1 (no arthritis) to 4 (severe arthritis)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 9, 2021
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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