Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis

NCT ID: NCT06514716

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-29
• Study Completion Date: 2025-05-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Geniculate Artery Embolization with Intra-articular Corticosteroid Injection (GAE with IACI)

Intervention Type: PROCEDURE

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).

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.

Group Type: ACTIVE_COMPARATOR

Geniculate Artery Embolization alone (GAE alone)

Intervention Type: PROCEDURE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Awad Bessar

Assistant Professor of Diagnostic and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A Bessar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

Locations

Zagazig University, Faculty of Medicine

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed A Bessar, MD, PhD

Role: CONTACT

Ahmedawadbessar@gmail.com

+201000089595

Facility Contacts

Ahmed A Bessar, MD, PhD

Role: primary

Other Identifiers

GAEIACI-OA

Identifier Type: -

Identifier Source: org_study_id