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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Pain, Musculoskeletal
• Intervention / Treatment: Procedure: Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI); Procedure: Geniculate Artery Embolization alone (GAE alone)

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed A Bessar, MD, PhD; Phone Number: +201000089595; Email: ahmedawadbessar@gmail.com

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Recruiting
    • Zagazig University, Faculty of Medicine
    • Contact: Ahmed A Bessar, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Diagnosed with knee osteoarthritis (OA) based on clinical and radiographic criteria.
• Eligible for geniculate artery embolization (GAE) as determined by the treating physician.
• Able to provide informed consent and comply with the study protocol.

Exclusion Criteria:

• Contraindications to corticosteroid injections or geniculate artery embolization.
• Pregnant or breastfeeding women.
• Active infection or skin condition at the injection site.
• Severe cardiovascular, renal, or hepatic diseases that may affect study participation.
• Previous knee surgery within the last 6 months.
• Participation in another clinical trial within the last 30 days.
• Inability to comply with follow-up visits or complete study assessments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GAE with IACI; Participants in this arm will undergo geniculate artery embolization (GAE) followed by an intraoperative intra-articular corticosteroid injection (IACI). The procedure aims to alleviate post-procedural pain and improve early functional outcomes in patients with knee osteoarthritis (OA).	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).
Active Comparator: GAE alone; Participants in this arm will undergo geniculate artery embolization (GAE) without the additional intraoperative intra-articular corticosteroid injection. This group will serve as the control to evaluate the effectiveness and safety of GAE with IACI in comparison.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline, 1 week, 2 weeks, and 4 weeks post-procedure.	1 week, 2 weeks, and 4 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Improvement (KOOS)	Functional improvement will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 week, 2 weeks, and 4 weeks post-procedure.	1 week, 2 weeks, and 4 weeks post-procedure
Functional Improvement (WOMAC)	Functional improvement will be assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 1 week, 2 weeks, and 4 weeks post-procedure.	1 week, 2 weeks, and 4 weeks post-procedure
Incidence of Procedure-Related Adverse Events	Monitoring and recording any adverse events related to the genicular nerve ablation procedures	Throughout the study period
Patient Satisfaction with the Procedure	Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure.	4 weeks post-procedure

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Ahmed A Bessar, MD, PhD, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pain Relief; Geniculate Artery Embolization; Functional Improvement; Intra-articular Corticosteroid Injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Osteoarthritis; Osteoarthritis, Knee; Musculoskeletal Pain
• Other Study ID Numbers: GAEIACI-OA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No