Knee Pain Chronic Clinical Trial
Official title:
Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Verified date | March 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Guerbet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | |
Secondary | 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. | 6 months | |
Secondary | Analgesic Utilization | Estimate the effect of genicular artery embolization on analgesic utilization as measured by morphine equivalents and non-steroidal anti-inflammatories utilization | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months |
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