Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction in Knee Pain
研究概览
简要总结
The goal of this study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment.
The main questions it aims to answer are:
- Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation?
- Is there a significant difference in functional improvement between the two techniques?
Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief, functional enhancement, safety profile, and patient satisfaction.
Participants will:
- Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation.
- Attend scheduled follow-up visits to assess pain levels, knee function, and any adverse events.
- Complete standardized questionnaires to provide feedback on pain relief, functional improvement, and overall satisfaction with the procedure.
详细描述
Background:
Knee osteoarthritis is a chronic degenerative joint disease affecting millions worldwide, characterized by progressive cartilage loss, inflammation, and pain. Despite various treatment options such as intra-articular corticosteroids, viscosupplementation, and PRP injections, many patients experience inadequate relief or adverse effects. Genicular nerve ablation has emerged as a promising minimally invasive technique to alleviate chronic knee pain by interrupting pain transmission from the genicular nerves to the central nervous system.
Rationale:
The rationale for comparing CT-guided and fluoroscopic-guided genicular nerve ablation lies in optimizing treatment outcomes while ensuring patient safety and satisfaction. CT-guided procedures offer unparalleled precision in nerve localization, potentially enhancing the accuracy of nerve ablation and improving clinical outcomes. However, this method involves higher radiation exposure compared to fluoroscopic guidance, which utilizes real-time imaging with lower radiation doses. Understanding which approach provides superior pain relief, functional improvement, and patient satisfaction is crucial for optimizing treatment protocols and guiding clinical practice.
Objectives:
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
In this randomized controlled trial, a partial blinding strategy is employed where only the outcomes assessors are blinded to intervention group assignments. Given the distinct nature of the CT-guided and fluoroscopic-guided procedures, it is impractical to blind participants and care providers. Operators performing the ablation and participants will be aware of the imaging technique used. However, to ensure unbiased evaluation of clinical outcomes, outcomes assessors will not know participants' group assignments. This measure is crucial for preventing observer bias in assessing primary and secondary outcomes such as pain relief, functional improvement, and patient satisfaction.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 45 to 80 years.
- •Diagnosed with knee osteoarthritis.
- •Knee osteoarthritis refractory to conservative treatment.
- •Able to provide informed consent.
- •Agree to follow the study procedures and attend follow-up visits.
排除标准
- •Prior knee surgery within the last six months.
- •Contraindications to genicular nerve ablation (e.g., certain types of infections, bleeding disorders).
- •Severe comorbid conditions that may interfere with the study outcomes (e.g., rheumatoid arthritis, other severe autoimmune diseases).
- •Current participation in another clinical trial that could interfere with the outcomes of this study.
- •Allergy or sensitivity to the materials used in the ablation procedures.
结局指标
主要结局
Reduction in Knee Pain
时间窗: 3 months post-procedure
This measure assesses the change in knee pain as reported by participants using the Visual Analog Scale (VAS). A lower score indicates less pain, signifying an improvement.
次要结局
- Improvement in Knee Function(Assessed at baseline, 1 month, 3 months, and 6 months post-procedure)
- Patient Satisfaction with the Procedure(3 months post-procedure)
- Incidence of Procedure-Related Adverse Events(From the time of procedure up to 6 months)
研究者
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Zagazig University