Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis

NCT06514716 | Recruiting

• 1 other identifier: GAEIACI-OA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Pain, Musculoskeletal

Keywords

Geniculate Artery Embolization; Intra-articular Corticosteroid Injection; Pain Relief; Functional Improvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Improvement (KOOS)

  1 week, 2 weeks, and 4 weeks post-procedure

• Functional Improvement (WOMAC)

  1 week, 2 weeks, and 4 weeks post-procedure

• Incidence of Procedure-Related Adverse Events

  Throughout the study period

• Patient Satisfaction with the Procedure

  4 weeks post-procedure

Study Arms (2)

GAE with IACI

EXPERIMENTAL

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)

GAE alone

ACTIVE COMPARATOR

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)

Interventions

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

Geniculate Artery Embolization alone (GAE alone) 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.

GAE alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University, Faculty of Medicine

Zagazig, 44519, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Musculoskeletal Pain

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ahmed A Bessar, MD, PhD

  Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Bessar, MD, PhD

CONTACT

+201000089595; Ahmedawadbessar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Diagnostic and Interventional Radiology

Model Details: Participants will be randomized into two groups: Group A receiving geniculate artery embolization (GAE) with intra-articular corticosteroid injection (IACI) and Group B receiving GAE alone.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: September 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)