Role of Intra-articular Corticosteroid Injection in Geniculate Artery Embolization for Knee Osteoarthritis: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection (IACI) in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The main questions it aims to answer are:
- Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone?
- Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone?
Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement.
Participants will:
- Undergo geniculate artery embolization, with or without intra-articular corticosteroid injection.
- Have their pain levels assessed using the Visual Analog Scale (VAS) at 1 week, 2 weeks, and 4 weeks post-procedure.
- Complete functional outcome assessments using the KOOS and WOMAC scores.
- Report any adverse events throughout the study period.
详细描述
This study is a prospective, randomized, comparative trial designed to evaluate the role of intra-articular corticosteroid injection (IACI) in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The trial will enroll adult participants diagnosed with knee OA who are eligible for GAE.
Participants will be randomized into two groups: Group A (GAE with IACI) and Group B (GAE alone). The primary outcome measure will be the Visual Analog Scale (VAS) pain scores at 1 week, 2 weeks, and 4 weeks post-procedure. Secondary outcome measures will include functional improvement assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC), patient-reported outcomes, and the incidence of adverse events.
The study aims to determine whether the addition of IACI to GAE provides better pain relief and functional outcomes compared to GAE alone. Data will be collected at baseline and specified time points post-procedure, and statistical analysis will be conducted to compare the outcomes between the two groups. This study is conducted in accordance with the principles of the Declaration of Helsinki and has received ethical approval from the institutional review board. Informed consent will be obtained from all participants before enrollment.
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
- Single (Outcomes Assessor)
盲法说明
Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older
- •Diagnosed with knee osteoarthritis (OA) based on clinical and radiographic criteria.
- •Eligible for geniculate artery embolization (GAE) as determined by the treating physician.
- •Able to provide informed consent and comply with the study protocol.
排除标准
- •Contraindications to corticosteroid injections or geniculate artery embolization.
- •Pregnant or breastfeeding women.
- •Active infection or skin condition at the injection site.
- •Severe cardiovascular, renal, or hepatic diseases that may affect study participation.
- •Previous knee surgery within the last 6 months.
- •Participation in another clinical trial within the last 30 days.
- •Inability to comply with follow-up visits or complete study assessments.
研究组 & 干预措施
GAE with IACI
Participants in this arm will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). The procedure aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA).
干预措施: Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI) (Procedure)
GAE alone
Participants in this arm will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This group will serve as the control to evaluate the effectiveness and safety of GAE with IACI in comparison.
干预措施: Geniculate Artery Embolization alone (GAE alone) (Procedure)
结局指标
主要结局
Change in Pain Intensity
时间窗: 1 week, 2 weeks, and 4 weeks post-procedure
Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline, 1 week, 2 weeks, and 4 weeks post-procedure.
次要结局
- Functional Improvement (WOMAC)(1 week, 2 weeks, and 4 weeks post-procedure)
- Incidence of Procedure-Related Adverse Events(Throughout the study period)
- Patient Satisfaction with the Procedure(4 weeks post-procedure)
- Functional Improvement (KOOS)(1 week, 2 weeks, and 4 weeks post-procedure)
研究者
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Zagazig University