Recruiting

Genicular Artery Embolization

Sponsor:

Joint & Vascular Institute

Code:

NCT07380906

Conditions

Knee Osteoarthristis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genicular Artery Embolization

Study Details

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:

1. Does GAE lead to sustained improvement in pain (WOMAC, VAS) and quality-of-life scores over 12-36 months?
2. What patient or procedural factors are associated with better outcomes after GAE?

Participants will:

  • 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

Study ID

NCT07380906

Start date

Jul 16, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Genicular Artery Embolization

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.

Primary outcome measure

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 5 years of enrollment/patient ]

Central Contacts and Locations

Locations

Joint and Vascular Institute

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

More Information

Sponsor

Joint & Vascular Institute

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • knee osteoarthritis
  • embolization
  • GAE
  • Genicular Artery Embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Joint & Vascular Institute on 2026-06-12.