Angioembolization in Knee Osteoarthritis
Conditions
Brief summary
To evaluate the efficacy and safety of genicular artery embolization in patients with symptomatic knee osteoarthritis refractory to conservative treatment.
Interventions
PROCEDUREgenicular artery embolization
Super-selective embolization of abnormal genicular arteries supplying the painful synovium in patients with symptomatic knee osteoarthritis.
DEVICECalibrated microspheres (100-300 µm)
Embolic microspheres used for occlusion of the targeted genicular arteries during embolization.
DEVICEMicrocatheter
A 2.0-2.4 Fr microcatheter used for super-selective catheterization of the genicular arteries.
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline in visual analog scale (VAS) pain score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score | 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. |
| Change from Baseline in Health-Related Quality of Life Score (EQ-5D-5L) | 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. |
| Technical Success Rate of Genicular Artery Embolization | During the procedure | Technical success is defined as successful selective catheterization and embolization of all target genicular arteries with completion of the planned procedure. |
Contacts
CONTACTRehab Awad Mohamed
STUDY_DIRECTORMoustafa Hashim Mahmoud
Assiut University
Outcome results
None listed