Embolization of Genicular Arteries for Treatment of Symptomatic Knee Osteoarthritis

N/ANot Yet RecruitingNCT07736248

Assiut University30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Angioembolization in Knee Osteoarthritis

Interventions

genicular artery embolizationPROCEDURE

Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.

Calibrated microspheres (100-300 µm)DEVICE

Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.

MicrocatheterDEVICE

A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline and 6 months after the Procedure

Secondary Outcomes

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

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.

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

Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L)

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.

Time frame: Baseline and 6 months after the procedure

Technical Success Rate of Genicular Artery Embolization

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

Time frame: During the procedure

Central Contacts

Rehab Awad Mohamed

CONTACT

2+01011511722 RehabAwad@aun.edu.eg

Data from ClinicalTrials.gov

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