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

Not Applicable

Withdrawn

• Conditions: Knee Swelling Pain; Arterial Occlusion; Knee Pain Chronic
• Interventions: Device: Embozene Microspheres

• Registration Number: NCT05248308
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-21
• Study Start: 2022-07-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2023-07-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genicular artery embolization	Embozene Microspheres	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.

Primary Outcome Measures

Name	Time	Method
KOOS - Pain subscale KOOS Scale - Pain	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 Outcome Measures

Name	Time	Method
MHI-5	6 months	Assess for associations between mental health and post TKA pain as assessed by the MHI-5 by comparing scores at 1 week, 1, 3, and 6 months to the pre-procedure score.
CRP & IL-6	6 months	Estimate the effect of genicular artery embolization on CRP and IL-6, by comparing baseline laboratory values to 6-month post procedure values.
Analgesic Utilization	6 months	Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization
VAS Scale	6 months	Estimate the effect of genicular artery embolization on the change in knee pain, as assessed by the VAS scale, at 1 week, 1, 3, and 6 months, in patients in patients with chronic knee pain following TKA.
KOOS - Non-Pain Components	6 months	Estimate effect in non-pain components of the KOOS score (KOOS Symptoms, KOOS ADL, KOOS Sport ADL, and KOOS QOL) by comparing these scores at 1 week, 1,3, and 6 months to the pre-procedure score.

Trial Locations

Locations (1)

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States