Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients … (NCT07763158) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis
Saudi Arabia60 participantsStarted 2024-07-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain evaluation post Genicular artery embolization using Western Ontario and McMaster Universities Osteoarthritis Index
Timeframe: from enrollment until 6 months after the procedure is done
2
Pain evaluation post Genicular artery embolization using Visual Analogue Scale
Timeframe: from enrollment until 6 months after the procedure is done
Trial details
NCT IDNCT07763158
SponsorKing Abdullah International Medical Research Center