Prospective Randomized Trial Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention Arm of genicular artery embolization
Intervention: embolization therapy (Procedure)
Control arm of conservative management
Intervention: Conservative treatment (Other)
Outcomes
Primary Outcomes
Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: from enrollment until 6 months after the procedure is done
To evaluate the role of genicular artery embolization in treatment of persistent pain using Western Ontario and McMaster Universities Osteoarthritis Index in patients with severe knee osteoarthritis. For the Western Ontario and McMaster Universities Osteoarthritis Index score it includes 3 parameters which are pain, stiffness, and physical function and scored from 0 to 4 having 0 as None and 4 as the most extreme for each variable, and for the total score having 0 is the best response and 96 is the worst.
Pain evaluation post Genicular artery embolization using Visual Analogue Scale
Time Frame: from enrollment until 6 months after the procedure is done
To evaluate the role of genicular artery embolization in treatment of persistent pain using Visual Analogue Scale in patients with severe knee osteoarthritis. For Visual Analogue Scale score it is used to assess the pain only from 0 to 10 having 0 is None and 10 is the most Extreme
Secondary Outcomes
- Functional status post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index(from enrollment until 6 months after the procedure is done)