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

Mass General Brigham

Status: Withdrawn

Conditions: Knee Pain Chronic; Arterial Occlusion; Knee Swelling Pain

Treatments: Device: Embozene Microspheres

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05248308

2022P000238

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Genicular artery embolization

Experimental group

Description:

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.

Treatment:

Device: Embozene Microspheres