Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- KOOS - Pain subscale KOOS Scale - Pain
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
KOOS - Pain subscale KOOS Scale - Pain
时间窗: 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
次要结局
- MHI-5(6 months)
- CRP & IL-6(6 months)
- Analgesic Utilization(6 months)
- VAS Scale(6 months)
- KOOS - Non-Pain Components(6 months)
研究者
Yan Epelboym, M.D.,M.P.H.
Principal Investigator
Brigham and Women's Hospital