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NCT Number: NCT06514716

Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University, Faculty of Medicine

Zagazig, 44519, Egypt

Location status: Recruiting

Location contact

Ahmed A Bessar, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Change in Pain Intensity

    Time frame: 1 week, 2 weeks, and 4 weeks post-procedure

    Pain intensity will be measured using the Visual Analog Scale (VAS) at baseline, 1 week, 2 weeks, and 4 weeks post-procedure.

Secondary outcomes

  1. Functional Improvement (KOOS)

    Time frame: 1 week, 2 weeks, and 4 weeks post-procedure

    Functional improvement will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 week, 2 weeks, and 4 weeks post-procedure.

  2. Functional Improvement (WOMAC)

    Time frame: 1 week, 2 weeks, and 4 weeks post-procedure

    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.

  3. Incidence of Procedure-Related Adverse Events

    Time frame: Throughout the study period

    Monitoring and recording any adverse events related to the genicular nerve ablation procedures

  4. Patient Satisfaction with the Procedure

    Time frame: 4 weeks post-procedure

    Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Bessar, MD, PhD

CONTACT

[email protected]

+201000089595

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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