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NCT Number: NCT07736248

Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.

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Key information

Conditions

Angioembolization in Knee Osteoarthritis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of knee osteoarthritis according to the criteria of the American College of Rheumatology.

Radiographic evidence of osteoarthritis corresponding to Kellgren-Lawrence grades I-III.

Moderate to severe knee pain for at least 6 months. Visual Analog Scale (VAS) score ≥5.

Failure of conservative treatment for at least 3 months including analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, lifestyle modification, or intra-articular injections.

Exclusion criteria

Kellgren-Lawrence grade IV osteoarthritis.
Previous knee arthroplasty.
Inflammatory arthropathies such as rheumatoid arthritis, psoriatic arthritis, or gout.
Active local or systemic infection.
Severe peripheral arterial disease.
Coagulation disorders.
Renal insufficiency (raised renal chemistry).
Pregnancy.
Known allergy to iodinated contrast media.
Refuse to provide written informed consent

Treatment and study plan

suerselective angioembolization of genicular artery in symptomatic knee OA

Other

Common femoral artery access will be obtained using ultrasound guidance. A 4-Fr or 5-Fr vascular sheath will be inserted. 5 Fr copra catheter or 5 Fr pernst catheters with be used. Diagnostic Angiography

Selective angiography of one or more of the following arteries will be performed using microcatheter :

Superior medial genicular artery.
Superior lateral genicular artery.
Inferior medial genicular artery.
Inferior lateral genicular artery.
Descending genicular artery.
Recurrent tibial artery branches.

Abnormal findings suggestive of synovial inflammation include:

Hypervascular blush.
Tumor-like neovascularity.
Early venous filling.
Increased periarticular vascularity. Superselective Embolization A microcatheter (1.7-2.4 Fr) will be advanced into target vessels.

Embolization will be performed using one of the following agents:

Imipenem/Cilastatin suspension.
Polyvinyl alcohol particles (100-300 μm).
Microspheres (100-300 μm).

Primary outcomes

change from baseline in visual analog scale (VAS) pain score

Time frame: Baseline and 6 months after the Procedure

pain intensity measured using the 10-cm visual analog scale (VAS). scores range from 0 to 10, with higher scores indicating greater pain. The change from baseline to 6 months after genicular artery embolization will be assessed.

Secondary outcomes

Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

Time frame: Baseline, 3 months, and 6 months after the procedure

Knee pain, stiffness, and physical function will be evaluated using the WOMAC questionnaire. Higher scores indicate more severe symptoms.
Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)

Time frame: Baseline and 6 months after the procedure

Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. Higher utility scores indicate better health status.
Technical Success Rate of Genicular Artery Embolization

Time frame: During the procedure

Technical success is defined as successful selective catheterization and embolization of all target genicular arteries with completion of the planned procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Rehab Awad Mohamed

CONTACT

[email protected]

2+01011511722

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Super Selective Angiographic Catheterization and Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jul 30, 2026
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.