Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07385560
Brief 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.
Detailed Description:
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
All procedures will be performed by a trained physiatrist using sterile technique and real-time ultrasonography. Outcome measures include VAS pain scores, KOOS, WOMAC, Rauschning-Lindgren classification, ultrasonographic cyst dimensions, and aspirated fluid volume. Assessments will be conducted at baseline and at 2-week, 1-month, and 3-month follow-up visits.
The primary objective is to investigate whether fenestration, when added to aspiration, enhances clinical outcomes and reduces recurrence rates. Secondary objectives include evaluating functional improvements, changes in cyst size, and patient-reported symptoms. The study duration for each participant is 3 months, and the overall study is planned to be completed within 5 months.
Study:
NCT07385560
Study Brief:
Protocol Section:
NCT07385560