Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction in KOOS pain subscore
研究概览
简要总结
Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients aged 40-80
- •Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)
- •Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale
- •Knee pain > 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)
- •Refusal of intra-articular corticosteroid injection
排除标准
- •Active malignancy
- •Active infection of the affected knee
- •Corticosteroid injection of the affected knee within 3 months of enrollment
- •Rheumatoid arthritis or other seronegative arthropathy
- •Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy
- •Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee
- •Pregnancy or expected pregnancy
- •GFR < 60 mL/min/1.73 m²
- •Anaphylactic reaction to iodinated contrast
- •Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS > 4
- •Body weight > 400 lbs (unsafe for angiography)
- •Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)
- •Type 1 diabetes mellitus
- •Long-acting corticosteroid use within 6 months (3 months for short-acting)
- •History or other evidence of acute kidney injury (AKI)
- •History of reaction to contrast media, bronchial asthma, or allergic disorders
- •History of hypersensitivity to gadolinium-based contrast agents (GBCAs)
- •Chronic widespread generalized pain >4 on VAS pain scale, including neuropathic pain
- •Major depressive disorder within 2 years before screening
- •Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- •Suicide attempt or suicidal behavior within 30 days before screening
- •Diagnosis of fibromyalgia
- •Considering total knee replacement in the next year
- •Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance
研究组 & 干预措施
GAE Arm
In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.
干预措施: Genicular Artery Embolization (Procedure)
GAE Arm
In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.
干预措施: Simple angiogram (Procedure)
Sham Arm
Participants assigned to the sham group undergo a similar preparatory process, including angiography and catheterization of all genicular arteries. However, no embolic agent is administered. Instead, after performing selective angiograms, these participants do not receive any embolization. 20 participants will be randomly allocated to this arm.
干预措施: Simple angiogram (Procedure)
GAE Arm
In this study, GAE is performed using the Lipiojoint technique described by Sapoval et al. This method utilizes a 3:1 emulsion of Lipiodol® (a transient embolic agent that penetrates distally to about 30 microns) and Optiray® to target the genicular arteries supplying areas of synovial hypervascularity and neo-angiogenesis. The embolic effect is temporary-lasting roughly 10 minutes-after which angiographic imaging shows resolution of the embolization with no damage to the surrounding skin, tendon, or bone. The endpoint of the procedure is to achieve complete stasis in the targeted vessels. 20 participants will be randomly allocated to this arm.
干预措施: Lipiodol (Device)
结局指标
主要结局
Reduction in KOOS pain subscore
时间窗: 3 months
Percent change in KOOS pain subscale score, scaled to a range of 0-100, from baseline to 3 months post-randomization of both GAE and sham groups.
次要结局
- VAS Score(0, 1, 6, 9, and 12 months)
- Crossover(3 months)
- WOMAC knee pain and dysfunction(1, 3, 6, 9, and 12 months.)
- KOOS pain and dysfunction(1, 3, 6, 9, and 12 months)
- Analgesic Reduction(Baseline, 1, 3, 6, 9, and 12 months post intervention)
- Whole Knee Synovitis Scoring(Baseline and 3 months)
- Perfusion(Procedure)
- Knee replacement(3 months)
- Corticosteroid injection usage(Baseline, 1, 3, 6, 9, and 12 months post intervention)