Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

August 1, 2026 updated by: Rehab Awad Mohamed Ahmed, Assiut University

Super Selective Angiographic Catheterization and 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.

  2. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: genicular artery embolization
Participants with symptomatic knee osteoarthritis will undergo super-selective genicular artery embolization using calibrated microspheres. Clinical outcomes will be assessed using pain and functional scores during follow-up.
Procedure: genicular artery embolization
Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.
Device: Calibrated microspheres (100-300 µm)
Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.
Device: Microcatheter
A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months after the Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the procedure
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 assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score ranges from 0 to 96, where 0 indicates no symptoms and 96 indicates the most severe symptoms. Higher scores indicate worse pain, stiffness, and functional limitation.
Baseline, 3 months, and 6 months after the procedure
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 EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system consists of five dimensions, each with five levels, and responses are converted into a utility index score ranging from values below 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health-related quality of life. Assessments will be performed at baseline, 3 months, and 6 months after the procedure.
Baseline and 6 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Moustafa Hashim Mahmoud, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

July 21, 2026

First Submitted That Met QC Criteria

July 25, 2026

First Posted (Actual)

July 30, 2026

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • angioembolization in knee OA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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