Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
WithdrawnNot applicableNCT05248308
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
- Conditions
- Knee Pain Chronic
- Knee Swelling Pain
- Arterial Occlusion
- Interventions
- Device: Embozene Microspheres
- Sponsor
- Brigham and Women's Hospital
- Collaborators
- Guerbet
- Start date
- 2022-07-01
- Primary completion
- 2023-07-01
- Sex
- All
- Age range
- from 40 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05248308