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Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis

NCT06514716 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Ahmed A Bessar, MD, PhD · Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-29
Primary Completion
2025-04-30
Completion
2025-05-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514716 on ClinicalTrials.gov