geniculaR Artery eMBolization for Knee Osteoarthritis (RAMBO) Registry (RAMBO)

June 10, 2026 updated by: Joint & Vascular Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 5 years of enrollment/patient
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint & Vascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1396188

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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