Percutaneous Transcatheter Genicular Embolization in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- VAS (Visual Analog Scale) score
研究概览
简要总结
This clinical study investigates a minimally invasive treatment called percutaneous transcatheter embolization of knee arteries for patients with chronic knee pain caused by advanced knee osteoarthritis or persistent pain after total knee replacement. Osteoarthritis of the knee is a common degenerative condition that can lead to long-term pain, reduced mobility, and decreased quality of life, and some patients do not achieve sufficient relief with standard treatments.
The study is based on the hypothesis that targeted embolization of small arteries supplying the inflamed tissues of the knee can safely reduce abnormal blood flow associated with inflammation, leading to pain relief and improved knee function. During the procedure, a thin catheter is guided through the blood vessels to the affected area of the knee, where a temporary embolic agent is administered to reduce pathological blood supply.
The aim of the study is to evaluate the safety and effectiveness of this procedure by assessing changes in pain intensity, knee function, and quality of life over a follow-up period of up to 24 months. The results of this study may help determine whether this minimally invasive approach can offer a new treatment option for patients who have limited alternatives for managing chronic knee pain
详细描述
This is a prospective, single-center, interventional pilot study designed to assess a catheter-based endovascular technique targeting pathological vascular changes associated with chronic knee pain. The intervention focuses on selective embolization of abnormal synovial and periarticular arterial branches identified by angiographic imaging as areas of increased perfusion related to inflammatory activity.
The procedure is performed in an angiography suite under local anesthesia. Vascular access is obtained via the common femoral artery, followed by selective catheterization of the arterial branches supplying the knee joint. Digital subtraction angiography is used to visualize hypervascular regions, typically seen as focal contrast enhancement ("blush"). These regions are considered targets for treatment. Embolization is carried out using a temporary embolic suspension administered through a microcatheter until adequate flow reduction in the target vessels is achieved, while preserving normal surrounding circulation.
Participants undergo standardized clinical and imaging assessments before the intervention and during scheduled follow-up visits over a two-year period. Follow-up evaluations are intended to capture longitudinal changes in clinical status and to monitor for any procedure-related adverse events. The study emphasizes procedural safety, technical feasibility, and post-interventional monitoring rather than comparison with alternative therapies.
Data collected during the study are analyzed using descriptive and paired statistical methods appropriate for an exploratory pilot design. The study is conducted in accordance with applicable ethical standards and regulatory requirements, with particular attention to patient safety, data protection, and transparency of reporting. The findings are expected to provide technical and clinical insights to inform future larger-scale studies and potential integration of this approach into clinical practice.
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
- •Adults aged 40 to 80 years
- •Clinical symptoms consistent with chronic knee pain
- •Radiographically confirmed knee osteoarthritis of Kellgren-Lawrence grade II-IV or persistent knee pain following total knee arthroplasty
- •Insufficient pain relief after standard conservative treatment (e.g., pharmacological therapy, physical therapy, or injections)
- •Ability to understand the study procedures and provide written informed consent _ Willingness and ability to comply with the study procedures and follow-up schedule
排除标准
- •Active local or systemic infection
- •Known coagulation disorders or ongoing anticoagulation that cannot be safely interrupted
- •Significant peripheral arterial disease affecting the lower limbs
- •Known allergy or contraindication to iodinated contrast agents
- •Severe renal impairment
- •History of fibromyalgia or other generalized chronic pain syndromes that may confound pain assessment
- •Pregnancy or breastfeeding
研究组 & 干预措施
Patients treated with genicular artery embolisation
干预措施: genicular artery embolisation (Procedure)
结局指标
主要结局
VAS (Visual Analog Scale) score
时间窗: In 1st, 3rd, 6th, 12th and 24th month after the procedure.
A VAS score for knee pain uses a 0-10 scale, where 0 means no pain, and 10 means the worst imaginable pain, helping quantify intensity, often categorized as mild (1-3), moderate (4-6), and severe (7-10) to assess pain levels or treatment effectiveness.
WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) score
时间窗: In 1st, 3rd, 6th, 12th and 24th month after the procedure.
The total WOMAC score can range from 0 to 96, with a higher number indicating greater disease severity. The final number is calculated by adding up the points in three separate subscales that assess pain (0-20 points), stiffness (0-8 points), and knee joint function (0-68 points).
KOOS (Knee Injury and Osteoarthritis Outcome Score) score
时间窗: In 1st, 3rd, 6th, 12th and 24th month after the procedure.
The KOOS score is a patient-completed questionnaire assessing knee health and function across five areas: Pain, Symptoms (stiffness/swelling), Activities of Daily Living (ADL), Sport \& Recreation, and Quality of Life (QoL). It uses a 0-100 scale (0=worst, 100=best) to track outcomes after knee injuries or arthritis, helping evaluate treatment effectiveness.
次要结局
- Analgetics use(In 1st, 3rd, 6th, 12th and 24th month after the procedure.)