Overview
The goal of this randomized clinical trial is to evaluate the role of genicular artery embolization (GAE) in treating persistent pain in patients with severe knee osteoarthritis who have failed conservative treatment and may be unable to undergo surgical treatment because of significant medical commodities. The main questions it aims to answer are:
Does genicular artery embolization reduce persistent knee pain in patients with severe knee osteoarthritis?
Researchers will compare patients who undergo genicular artery embolization with patients who continue conservative treatment, including NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections, to evaluate differences in pain.
Participants will:
- Undergo assessment of knee pain and function using the Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score before treatment.
- Be randomly assigned to either genicular artery embolization or continued conservative treatment.
- Have pain and functional outcomes assessed before treatment and at 6 weeks, 3 months, and 6 months after the intervention.
Description
Randomized control trial were subjects will be chosen through envelop opaque technique, and all subjects will be included according to inclusion and exclusion criteria The intervention of interest is genicular artery embolization and our main outome is assessing pain post procedure The control group will be patients on conservative therapy such as (NSAIDS, physiotherapy, weight reduction programm, Intrarticular injections) This control group will be compared to the other two limbs of the study which are patinet who undergo embolization Assessing pain as primary objective and function as secondary objective will be through used tools such as WOMAC score, VAS, score.
Pain and funtion variables will be collected in the following manner:
- Pre procedure
- Six weeks after the procedure - 3 months after the procedure - 6 months after the procedure
The data will be entered to Microsoft Excel and then be analyzed on Statistical Package for the Social Sciences (SPSS) version 22.
Eligibility
Inclusion Criteria:
Adults aged 18 years or older of either sex. Diagnosis of knee osteoarthritis with a Kellgren-Lawrence grade of 3 or higher. Persistent knee pain resistant to conservative treatment for at least 3 months. Conservative treatment includes NSAIDs, physiotherapy, weight reduction programs, and intra-articular injections.
Patients with multiple comorbidities who are indicated for operative treatment, such as total knee arthroplasty, for pain management but are unable to undergo surgery due to their medical status.
Exclusion Criteria:
Previous knee arthroplasty in the affected knee. Known malignancy. Local infection. Rheumatoid arthritis. Intra-articular injection in the affected knee within the previous 6 months. Body weight greater than 150 kg. Renal impairment. Irreversible coagulopathy. Peripheral vascular disease.
Study Population:
Patients will be recruited from King Abdulaziz Medical City, National Guard Hospital, Jeddah, Saudi Arabia.
