Status:
WITHDRAWN
Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Guerbet
Conditions:
Knee Pain Chronic
Knee Swelling Pain
Eligibility:
All Genders
40-80 years
Phase:
NA
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 TK...
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 arthro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05248308
Start Date
July 1 2022
End Date
September 1 2023
Last Update
March 9 2023
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115