Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Primary Purpose
Knee Pain Chronic, Knee Swelling Pain, Arterial Occlusion
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Embozene Microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain Chronic
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Genicular artery embolization
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
VAS Scale
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.
Analgesic Utilization
Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization
KOOS - Non-Pain Components
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.
MHI-5
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
Estimate the effect of genicular artery embolization on CRP and IL-6, by comparing baseline laboratory values to 6-month post procedure values.
Full Information
NCT ID
NCT05248308
First Posted
February 10, 2022
Last Updated
March 7, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Guerbet
1. Study Identification
Unique Protocol Identification Number
NCT05248308
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Fundings challenges
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Guerbet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic, Knee Swelling Pain, Arterial Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Genicular artery embolization
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Embozene Microspheres
Intervention Description
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.
Primary Outcome Measure Information:
Title
KOOS - Pain subscale KOOS Scale - Pain
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
VAS Scale
Description
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.
Time Frame
6 months
Title
Analgesic Utilization
Description
Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization
Time Frame
6 months
Title
KOOS - Non-Pain Components
Description
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.
Time Frame
6 months
Title
MHI-5
Description
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.
Time Frame
6 months
Title
CRP & IL-6
Description
Estimate the effect of genicular artery embolization on CRP and IL-6, by comparing baseline laboratory values to 6-month post procedure values.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Epelboym, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
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