Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Improvement (KOOS) | Functional improvement will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 week, 2 weeks, and 4 weeks post-procedure. | 1 week, 2 weeks, and 4 weeks post-procedure |
| Functional Improvement (WOMAC) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed A Bessar, MD, PhD | Contact | +201000089595 | Ahmedawadbessar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Bessar, MD, PhD | Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University, Faculty of Medicine | Recruiting | Zagazig | 44519 | Egypt |
At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
|
| 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. |
|
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. |
| 1 week, 2 weeks, and 4 weeks post-procedure |
| Incidence of Procedure-Related Adverse Events | Monitoring and recording any adverse events related to the genicular nerve ablation procedures | Throughout the study period |
| Patient Satisfaction with the Procedure | Measured using a structured patient satisfaction questionnaire (PSQ) to gauge participants' satisfaction with the pain relief and overall experience of the procedure. | 4 weeks post-procedure |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009135 | Muscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided