Clinical trial NCT06514716: Intra-articular Corticosteroid Injection in GAE for Knee Knee Osteoarthritis
Official title: Role of Intra-articular Corticosteroid Injection in Geniculate Artery Embolization for Knee Osteoarthritis: A Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Pain, Musculoskeletal
Keywords: Geniculate Artery Embolization
Intra-articular Corticosteroid Injection
Pain Relief
Functional Improvement
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: 1 week, 2 weeks, and 4 weeks post-procedure
Secondary outcomes:
measure: Functional Improvement (KOOS)
timeFrame: 1 week, 2 weeks, and 4 weeks post-procedure
measure: Functional Improvement (WOMAC)
timeFrame: 1 week, 2 weeks, and 4 weeks post-procedure
measure: Incidence of Procedure-Related Adverse Events
timeFrame: Throughout the study period
measure: Patient Satisfaction with the Procedure
timeFrame: 4 weeks post-procedure
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of Medicine
Study officials:
affiliation: Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
name: Ahmed A Bessar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: