"The Importance of Adding Fenestration to Ultrasound-Guided Baker's Cyst Aspiration" (NCT07385560) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
"The Importance of Adding Fenestration to Ultrasound-Guided Baker's Cyst Aspiration"
Turkey (Türkiye)44 participantsStarted 2026-02-15
Plain-language summary
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:
1. aspiration with corticosteroid and lidocaine injection, or
2. 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Baker's Cyst Volume
Timeframe: Baseline, 2 weeks, 1 month, and 3 months after the intervention