Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain

NCT05248308 | Withdrawn FDA Device

• 1 other identifier: 2022P000238
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Pain Chronic; Knee Swelling Pain; Arterial Occlusion

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (5)

• VAS Scale

  6 months

• Analgesic Utilization

  6 months

• KOOS - Non-Pain Components

  6 months

• MHI-5

  6 months

• CRP & IL-6

  6 months

Study Arms (1)

Genicular artery embolization

EXPERIMENTAL

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.

Device: Embozene Microspheres

Interventions

Embozene Microspheres DEVICE

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.

Genicular artery embolization

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Guerbet: collaborator

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan Epelboym, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

US (1)