NCT06514716

Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis

Role of Intra-articular Corticosteroid Injection in Geniculate Artery Embolization for Knee Osteoarthritis: A Comparative Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the effectiveness and safety of intra-articular corticosteroid injection (IACI) in alleviating post-procedural pain and improving early outcomes in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The main questions it aims to answer are: * Does intra-articular corticosteroid injection reduce pain levels post-procedure compared to GAE alone? * Does the combination of GAE and IACI improve functional outcomes and patient-reported outcomes compared to GAE alone? Investigators will compare patients receiving GAE with IACI to those receiving GAE alone to see if the addition of IACI provides superior pain relief and functional improvement. Participants will: * Undergo geniculate artery embolization, with or without intra-articular corticosteroid injection. * Have their pain levels assessed using the Visual Analog Scale (VAS) at 1 week, 2 weeks, and 4 weeks post-procedure. * Complete functional outcome assessments using the KOOS and WOMAC scores. * Report any adverse events throughout the study period.

Detailed description

This study is a prospective, randomized, comparative trial designed to evaluate the role of intra-articular corticosteroid injection (IACI) in patients undergoing geniculate artery embolization (GAE) for knee osteoarthritis (OA). The trial will enroll adult participants diagnosed with knee OA who are eligible for GAE. Participants will be randomized into two groups: Group A (GAE with IACI) and Group B (GAE alone). The primary outcome measure will be the Visual Analog Scale (VAS) pain scores at 1 week, 2 weeks, and 4 weeks post-procedure. Secondary outcome measures will include functional improvement assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC), patient-reported outcomes, and the incidence of adverse events. The study aims to determine whether the addition of IACI to GAE provides better pain relief and functional outcomes compared to GAE alone. Data will be collected at baseline and specified time points post-procedure, and statistical analysis will be conducted to compare the outcomes between the two groups. This study is conducted in accordance with the principles of the Declaration of Helsinki and has received ethical approval from the institutional review board. Informed consent will be obtained from all participants before enrollment.

Conditions

• Knee Osteoarthritis
• Pain, Musculoskeletal

Interventions

Type	Name	Description
PROCEDURE	Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI)	Participants will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). This combination aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA).
PROCEDURE	Geniculate Artery Embolization alone (GAE alone)	Participants will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This procedure aims to serve as a control to evaluate the effectiveness and safety of GAE with IACI in comparison.

Timeline

• Start date: 2024-09-29
• Primary completion: 2025-04-30
• Completion: 2025-05-30
• First posted: 2024-07-23
• Last updated: 2024-10-01

Locations

1 site across 1 country: Egypt