Clinical trial NCT05248308: Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Official title: Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Pain Chronic
Knee Swelling Pain
Arterial Occlusion
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2022-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Ambulatory
2. History of total knee arthroplasty or revision arthroplasty in the symptomatic knee
3. Moderate to severe knee pain: pain VAS ≥50 mm
4. Knee pain resistant to at least 3 months of conservative therapy including pharmacologic therapy or intra-articular injection.
5. Absence of pregnancy at time of screening as determined by urine HCG
6. Provision of signed and dated informed consent form
7. 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:

1. 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
2. History of inflammatory arthropathy such as rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus
3. Presence of non-MRI compatible devices (e.g., cardiac pacemaker).
4. Known history of anaphylaxis to iodinated or gadolinium-based contrast agents
5. BMI greater than 50
6. Renal dysfunction as defined by serum creatinine \>1.6 dl/mg or eGFR \<60 obtained within 30 days of procedure.
7. Uncorrectable coagulopathy (platelet count \< 50,000, international normalized ratio \>1.5 within 30 days of procedure
8. Active systemic or local knee infection
9. Pregnant or intent to become pregnant during the study

Primary outcomes:
measure: KOOS - Pain subscale KOOS Scale - Pain
timeFrame: 6 months
Secondary outcomes:
measure: VAS Scale
timeFrame: 6 months
measure: Analgesic Utilization
timeFrame: 6 months
measure: KOOS - Non-Pain Components
timeFrame: 6 months
measure: MHI-5
timeFrame: 6 months
measure: CRP & IL-6
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Yan Epelboym, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: