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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Device: Embosphere Microspheres

• Registration Number: NCT05112926
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-09
• Study Start: 2022-12-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embosphere Microspheres group	Embosphere Microspheres	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.

Primary Outcome Measures

Name	Time	Method
Change in knee pain as assessed by the WOMAC	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.
Incidence of treatment related adverse events	Up to 4 weeks (Post Embolization Surgery)	Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician

Secondary Outcome Measures

Name	Time	Method
Change in knee pain as assessed by VAS	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
WORMS Score for Synovitis	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
Kellgren-Lawrence Grade	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)
Change in knee pain	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.
Incidence of adverse events	Up to 52 weeks (Post Embolization Surgery)	Procedure-related and target knee osteoarthritis-related adverse events as assessed by treating physician

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States