Prospective Registry For Genicular Artery Embolization At The Joint & Vascular Institute

NCT07380906 | Recruiting

• 1 other identifier: 1396188
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study (prospective registry) is to collect long-term real-world data on the effectiveness and safety of genicular artery embolization (GAE) for knee osteoarthritis in adults aged 18 years or older with symptomatic KOA that has not responded to medical therapy. The main questions it aims to answer are:

• Undergo GAE as part of their routine clinical care.
• Complete clinical follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months after treatment, including symptom and quality-of-life questionnaires.
• Have safety outcomes tracked according to Society of Interventional Radiology guidelines. There is no comparison group; results will be analyzed to identify predictors of success and inform best practices for patient selection and treatment.

Conditions

Knee Osteoarthristis

Keywords

knee osteoarthritis; embolization; GAE; Genicular Artery Embolization

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  The investigators will describe differences in pain response with Genicular Artery Embolization (GAE) compared to a sham procedure when treating medically refractory mild to moderate Knee Osteoarthritis (KOA) at 12 months as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score. A higher score index a higher pain level while a lower score indicates lower pain levels. The score range is 0 to 96.

  5 years of enrollment/patient

Interventions

Genicular Artery Embolization PROCEDURE

Genicular Artery Embolization (GAE) is a minimally invasive, image-guided procedure in which embolic agents are delivered into hyperemic genicular arteries to reduce synovial inflammation and knee pain from osteoarthritis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (18 years and older) presenting to the Joint \& Vascular Institute for clinical consultation regarding symptomatic knee osteoarthritis. This population includes individuals who have failed standard medical management and are seeking minimally invasive alternatives to total knee arthroplasty. The registry will include men and women of all races and ethnicities without exclusion, provided they meet the clinical criteria for GAE as determined by the Principal Investigator or Sub-Investigators.

You may qualify if:

• Adults (≥18 years) with symptomatic KOA refractory to medical therapy, referred for GAE.

You may not qualify if:

• Pregnancy, coagulopathy, severe comorbidities, or inability to consent.

Sponsors & Collaborators

• Joint & Vascular Institute: lead

Study Sites (1)

Joint and Vascular Institute

Libertyville, Illinois, 60048, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 2, 2026
• Study Start: July 16, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (1)