Knee Osteoarthritis, Pain, Musculoskeletal
Conditions
Keywords
Geniculate Artery Embolization, Intra-articular Corticosteroid Injection, Pain Relief, Functional Improvement
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.
Interventions
PROCEDUREGeniculate 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).
PROCEDUREGeniculate 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.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement (KOOS) | 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. |
| Functional Improvement (WOMAC) | 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. |
| Incidence of Procedure-Related Adverse Events | Throughout the study period | Monitoring and recording any adverse events related to the genicular nerve ablation procedures |
| Patient Satisfaction with the Procedure | 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. |
Countries
Egypt
Contacts
Primary ContactAhmed A Bessar, MD, PhD
Outcome results
None listed