Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
The goal of this study is to create a prospective registry (\<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >=18
Bilateral or unilateral knee pain attributed to knee osteoarthritis (KOA). For bilateral KOA patients, the more severe knee will be permitted inclusion to the registry
Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
Knee pain >6 months refractory to conservative medical management (Nonsteroidal anti-inflammatory drugs, acetaminophen, etc.)
Disqualifiers
Active malignancy
Active infection of the affected knee
Platelets <50,000/uL, INR >2.0 (unless on anticoagulation that can be reversed or performing radial/pedal access without reversal)
Corticosteroid injection of the affected knee within 3 months of enrollment
Trial population
Patients with medically refractory knee osteoarthritis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Registry (N/A)
Other interventionThis study is a registry, thus no research intervention is being directly tested.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Registry1 intervention
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 100.
Time frame
1 year of enrollment/patientSecondary outcomes
1
Incidence of Genicular Artery Embolization Emergent Adverse Events
The investigators will assess GAE-related adverse events to better understand its net benefit. Angiography with embolization is an invasive procedure with knowns risks that include bleeding (i.e. hematoma, arterial perforation), infection, and non-target embolization.35 Outcomes will be recorded as intra-procedure events along with assessments at 3, 6, 9, and 12 months post procedure. Complications will be recorded per the Society of Interventional Radiology Quality Improvement Standards for Percutaneous Transcatheter Embolization.
Time frame
1 year of enrollment/patientSponsors and contacts
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Source ClinicalTrials.gov