This study seeks to evaluate the safety and efficacy of genicular artery embolization (GAE) as a treatment for patients with chronic pain following primary total knee arthroplasty (TKA) or revision TKA at 6 months as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS).
This is a single center, single arm, prospective pilot study evaluating the safety and efficacy of genicular artery embolization (GAE) for treatment of chronic pain following primary total knee arthroplasty (TKA) or revision TKA. Following screening, eligible participants will be offered enrollment. Patients who demonstrate baseline imaging findings of knee synovitis either on US, MRI, or both modalities will be offered GAE. Genicular artery embolization will be performed using a SeQure® microcatheter (Guerbet LLC, Villepinte, France) using Embozene microspheres (Varian Medical Systems, Palo Alto, CA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Embozene Microspheres are manufactured by Varian Medical Systems (Palo Alto, CA). These microspheres are non-resorbable hydrogel microspheres coated with polyzene-F. Embozene microspheres are approved for use in treating arteriovenous malformations, hypervascular tumors such as uterine fibroids and hepatomas, and prostatic arteries in patients with benign prostatic hyperplasia. One of the causes of chronic pain in the setting of a knee arthroplasty may be increased blood flow to the specific area(s) of pain. The purpose of this procedure is to reduce blood flow (embolize) to specific parts of the knee which are contributing to your pain. This procedure is performed by infusing the Embozene particles into specific knee arteries (genicular arteries) in the region of knee pain.
Brigham & Women's Hospital
Boston, Massachusetts, United States
KOOS - Pain subscale KOOS Scale - Pain
Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the KOOS, at 6 months post vs. pre-intervention, in patients with chronic knee pain following TKA
Time frame: 6 months
VAS Scale
Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the VAS scale, at 1 week, 1, 3, and 6 months, in patients in patients with chronic knee pain following TKA.
Time frame: 6 months
Analgesic Utilization
Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization
Time frame: 6 months
KOOS - Non-Pain Components
Estimate effect in non-pain components of the KOOS score (KOOS Symptoms, KOOS ADL, KOOS Sport ADL, and KOOS QOL) by comparing these scores at 1 week, 1,3, and 6 months to the pre-procedure score.
Time frame: 6 months
MHI-5
Assess for associations between mental health and post TKA pain as assessed by the MHI-5 by comparing scores at 1 week, 1, 3, and 6 months to the pre-procedure score.
Time frame: 6 months
CRP & IL-6
Estimate the effect of genicular artery embolization on CRP and IL-6, by comparing baseline laboratory values to 6-month post procedure values.
Time frame: 6 months
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