"The Importance of Adding Fenestration to Ultrasound-Guided Baker's Cyst Aspiration"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Baker's Cyst Volume
研究概览
简要总结
This study aims to evaluate whether adding a fenestration procedure to standard ultrasound-guided aspiration and corticosteroid-lidocaine injection provides additional clinical benefits for patients with symptomatic Baker's cyst associated with knee osteoarthritis. Baker's cyst is a fluid-filled swelling located behind the knee that may cause pain, stiffness, swelling, and limited mobility. Although aspiration with medication injection is commonly used to relieve symptoms, recurrence of the cyst is frequent.
Fenestration is a minimally invasive technique in which small controlled openings are created in the cyst wall under ultrasound guidance to improve internal drainage and potentially reduce recurrence. In this prospective, randomized, double-blind, controlled study, participants will be assigned to one of two groups:
- aspiration with corticosteroid and lidocaine injection, or
- aspiration with corticosteroid and lidocaine injection plus fenestration.
Pain, functional scores, cyst measurements, and recurrence will be assessed at follow-up visits at 2 weeks, 1 month, and 3 months. The purpose of this study is to determine whether the addition of fenestration results in better symptom improvement and lower rates of recurrence compared with standard aspiration alone.
详细描述
Baker's cyst, also known as a popliteal cyst, is frequently observed in patients with knee osteoarthritis and is typically associated with intra-articular pathology that increases synovial fluid production. Ultrasound-guided aspiration combined with corticosteroid-lidocaine injection is a widely used minimally invasive treatment; however, recurrence remains a significant limitation of this method.
Fenestration involves creating multiple small perforations in the cyst wall using a needle under real-time ultrasound guidance. This technique is expected to enhance communication between the cyst and surrounding tissues, promote better fluid redistribution, and reduce the likelihood of reaccumulation.
This prospective, randomized, double-blind, controlled clinical trial will enroll adult patients meeting the 2010 ACR criteria for knee osteoarthritis and demonstrating a symptomatic Baker's cyst on ultrasound. Participants will be randomized in a 1:1 ratio into two groups:
Group 1: aspiration + corticosteroid-lidocaine injection
Group 2: aspiration + corticosteroid-lidocaine injection + fenestration
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, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants and investigators who perform evaluations are blinded to group assignment. The clinician performing the ultrasound-guided procedure is not involved in outcome assessments.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 75 years
- •Diagnosis of knee osteoarthritis according to the 2010 American College of Rheumatology (ACR) criteria
- •Presence of a symptomatic Baker's cyst confirmed by ultrasonography
- •Ability to understand study procedures and provide written informed consent
- •Sufficient intellectual and social capacity to comply with study visits and follow-up requirements
排除标准
- •Presence of inflammatory arthritis, septic arthritis, crystal arthropathy, or secondary causes of knee osteoarthritis
- •Kellgren-Lawrence grade 4 knee osteoarthritis
- •Active systemic infection
- •History of malignancy
- •Intra-articular knee injection within the past 3 months
- •Knee trauma within the past 3 months
- •History of knee surgery
- •Contraindications to aspiration or corticosteroid injection (e.g., local infection, bleeding disorders, uncontrolled diabetes mellitus)
- •Requirement to continue medications for inflammatory arthritis
- •Diagnosed psychiatric disorder that may impair study participation
- •Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the past 1 week
- •Physical therapy applied to the knee region within the past 1 month
研究组 & 干预措施
Aspiration + Steroid-Lidocaine
Ultrasound-guided aspiration of Baker's cyst followed by injection of corticosteroid and lidocaine mixture. No fenestration is performed.
干预措施: Baker's Cyst Aspiration (Procedure)
Aspiration + Steroid-Lidocaine
Ultrasound-guided aspiration of Baker's cyst followed by injection of corticosteroid and lidocaine mixture. No fenestration is performed.
干预措施: Steroid-Lidocaine Injection (Drug)
Arm Title: Aspiration + Steroid-Lidocaine + Fenestration
Ultrasound-guided aspiration followed by corticosteroid-lidocaine injection and fenestration using multiple needle perforations under real-time ultrasound guidance.
干预措施: Baker's Cyst Aspiration (Procedure)
Arm Title: Aspiration + Steroid-Lidocaine + Fenestration
Ultrasound-guided aspiration followed by corticosteroid-lidocaine injection and fenestration using multiple needle perforations under real-time ultrasound guidance.
干预措施: Steroid-Lidocaine Injection (Drug)
Arm Title: Aspiration + Steroid-Lidocaine + Fenestration
Ultrasound-guided aspiration followed by corticosteroid-lidocaine injection and fenestration using multiple needle perforations under real-time ultrasound guidance.
干预措施: Ultrasound-Guided Fenestration (Procedure)
结局指标
主要结局
Change in Baker's Cyst Volume
时间窗: Baseline, 2 weeks, 1 month, and 3 months after the intervention
Baker's cyst volume measured by ultrasonography using three-dimensional linear measurements (height × width × depth) and calculated in cubic millimeters (mm³). Volume measurements will be compared between the two study groups (Aspiration + Steroid-Lidocaine vs. Aspiration + Steroid-Lidocaine + Fenestration). All measurements will be performed by a blinded physician using a 7-13 MHz linear transducer. Lower values indicate a reduction in cyst size.
次要结局
- Change in Pain Severity (NRS Score)(Baseline, 1 hour post-procedure, 2 weeks, 1 month, 3 months.)
- Change in Rauschning-Lindgren Classification (RLC)(Baseline, 2 weeks, 1 month, 3 months.)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)(Baseline, 2 weeks, 1 month, 3 months.)
- Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline, 2 weeks, 1 month, 3 months.)
- Baseline OMERACT Ultrasound Score(Baseline)
- Change in Kellgren-Lawrence (K-L) Grade(Baseline only)
- Change in Cyst Characteristics on Ultrasound(Baseline, 2 weeks, 1 month, 3 months.)
- Aspirated Fluid Volume(During the procedure (single time point).)
- Change in Ultrasound Effusion Grade (OMERACT)(Baseline, 2 weeks, 1 month, and 3 months)
研究者
Tutku naz bulut
Resident Physician, Department of Physical Medicine and Rehabilitation
Istanbul University - Cerrahpasa