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

NCT ID: NCT05248308

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-09-01

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).

Conditions

Knee Pain Chronic; Knee Swelling Pain; Arterial Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Embozene Microspheres

Intervention Type: 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.

Interventions

Embozene Microspheres

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yan Epelboym, M.D.,M.P.H.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Epelboym, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2022P000238

Identifier Type: -

Identifier Source: org_study_id