RECRUITING Not applicable ClinicalTrials.gov

Evaluating the Role of Genicular Artery Embolization in Treatment of Persistent Pain in Patients With Severe Knee Osteoarthritis

Sponsor: King Abdullah International Medical Research Center • ClinicalTrials.gov ID: NCT07763158

Registry updated: 2026-08-19

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

embolization therapy (Procedure)
GAE: Genicular artery embolization GAE To be performed under local anesthesia \- Immediately prior to the procedure, the focal areas of pain identified by the patient should be marked with a radiopaque marker.. Access to the ipsilateral common femoral artery is performed with a 21-gauge needle, with exchange to a 3-French vascular sheath which is replaced by 5 French one 11 cm length by using a metallic guide wire. * 4Fr. 65-cm-angled Glidecath to be advanced into the mid-to-distal portion of the superficial femoral artery, proximal to the descending genicular artery origin. * The selection of which artery to embolize is based on the angiographic evidence of hyperemia at the cartilage level Embolization is performed with 100-300mm Embozene particles. Embolization is performed until distal hypervascularity resolved, yet normal arterial flows is preserved within the selected artery. * After embolization, a completion femoral artery angiogram should be performed. Compression for 5 minute
Conservative treatment (Other)
NSAIDS, physiotherapy, weight reduction programm, or Intrarticular injections for at least 3-6 months

Eligibility criteria

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.

Conditions

Osteoarthitis

Locations

King Abdullah International Medical Research Center — Jeddah, Mecca Region, Saudi Arabia

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment