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"The Importance of Adding Fenestration to Ultrasound-Guided Baker's Cyst Aspiration"

NCT07385560 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-02-15
Last updated
2026-02-04

Condition(s) studied

Baker CystFenestrationMusculoskeletal UltrasoundSteroid InjectionOMERACTKnee Osteoarthritis

Investigational drug(s) / intervention(s)

Baker's Cyst AspirationSteroid-Lidocaine InjectionUltrasound-Guided Fenestration

Baker's Cyst Aspiration: With the patient in the prone position, the ultrasound probe is placed transversely over the gastrocnemius-semimembranosus bursa. Under real-time ultrasound guidance, the needle is advanced while visualizing neurovascular structures to avoid injury. Aspiration of the cyst content is performed in all participants.

Steroid-Lidocaine Injection: Following aspiration, an injection mixture consisting of 1 mL betamethasone, 1 mL of 2% lidocaine, and 1 mL of 0.9% isotonic sodium chloride is administered into the decompressed cyst cavity under ultrasound guidance.

Ultrasound-Guided Fenestration: After aspiration, fenestration of the cyst wall is performed under ultrasound guidance. The cyst wall is punctured at a minimum of six different points using a needle to create communication with surrounding tissues and reduce recurrence. Following fenestration, the same steroid and local anesthetic mixture is administered.

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Baker's Cyst Volume — 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.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Physical Medicine and Rehabilitation Istanbul Istanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07385560 on ClinicalTrials.gov ↗ ← All trials in Turkey