geniculaR Artery eMBolization for Knee Osteoarthritis (RAMBO) Registry
ConditionKnee Osteoarthristis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJoint & Vascular Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) with symptomatic KOA refractory to medical therapy, referred for GAE.
Disqualifiers
Pregnancy, coagulopathy, severe comorbidities, or inability to consent.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Genicular Artery Embolization
Procedure/SurgeryGenicular 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
5 years of enrollment/patientSponsors and contacts
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Source ClinicalTrials.gov