Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Brigham and Women's Hospital
- Locations
- 1
- Primary Endpoint
- KOOS - Pain subscale KOOS Scale - Pain
Study Overview
Brief Summary
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).
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of total knee arthroplasty or revision arthroplasty in the symptomatic knee
- •Moderate to severe knee pain: pain VAS ≥50 mm
- •Knee pain resistant to at least 3 months of conservative therapy including pharmacologic therapy or intra-articular injection.
- •Absence of pregnancy at time of screening as determined by urine HCG
- •Provision of signed and dated informed consent form
- •Willing, able, and mentally competent to provide informed consent and to tolerate angiography, US, and MRI.
Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •History of severe peripheral arterial disease symptoms including claudication, diminished or absent lower extremity pulses, leg numbness or weakness or known arterial atherosclerosis or occlusion that would limit selective angiography
- •History of inflammatory arthropathy such as rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus
- •Presence of non-MRI compatible devices (e.g., cardiac pacemaker).
- •Known history of anaphylaxis to iodinated or gadolinium-based contrast agents
- •BMI greater than 50
- •Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 obtained within 30 days of procedure.
- •Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure
- •Active systemic or local knee infection
- •Pregnant or intent to become pregnant during the study
Arms & Interventions
Genicular artery embolization
Study participants will undergo genicular artery embolization (GAE) for treatment of chronic moderate to severe pain following knee arthroplasty or revision arthroplasty. Embolization will be performed using Embozene Microspheres.
Intervention: Embozene Microspheres (Device)
Outcomes
Primary Outcomes
KOOS - Pain subscale KOOS Scale - Pain
Time Frame: 6 months
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
Secondary Outcomes
- MHI-5(6 months)
- CRP & IL-6(6 months)
- Analgesic Utilization(6 months)
- VAS Scale(6 months)
- KOOS - Non-Pain Components(6 months)
Investigators
Yan Epelboym, M.D.,M.P.H.
Principal Investigator
Brigham and Women's Hospital