Trial results for a study investigating geniculate artery embolization for Osteoarthritis were posted on ClinicalTrials.gov on 2025-05-31, reporting a mean reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of -50.1%.
Background
Osteoarthritis is a chronic, progressive joint disease characterized by the breakdown of cartilage, leading to pain, stiffness, and reduced physical function. It commonly affects the knees, hips, and hands, significantly impacting quality of life. Current treatments range from conservative measures like medication and physical therapy to more invasive options such as joint injections and surgical replacement. Exploring less invasive, targeted interventions that can alleviate symptoms, particularly pain, for patients with mild to moderate radiographic knee osteoarthritis remains an important area of research.
Trial design
This completed study was a single-arm, single-center, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee osteoarthritis. The trial enrolled 38 participants with Osteoarthritis. Eligible participants received geniculate artery embolization using Embozene™ Color-Advanced Microspheres and were followed up for a total of 12 months. The study is designated as Phase NA.
Key results
The trial reported several key measurements for the Embolization Group:
- Percentage Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Score:
- A mean of -50.1 (Standard Deviation 26.4) percentage change was observed.
- Change in WOMAC - Pain Score:
- A mean of -39.6 (Standard Deviation 36.7) percentage change was observed.
- A mean of -43.70 (Standard Deviation 48.9) percentage change was observed.
- Change in Visual Analogue Scale (VAS) Rating of Knee Pain:
- A mean of -48.50 (Standard Deviation 33.6) percentage change was observed.
- A mean of -50.80 (Standard Deviation 37.9) percentage change was observed.
- A mean of -55.40 (Standard Deviation 3770.00) percentage change was observed.
- Change in WOMAC - Stiffness Score:
- A mean of -39.80 (Standard Deviation 41.5) percentage change was observed.
- A mean of -35 (Standard Deviation 50.4) percentage change was observed.
- A mean of -43.30 (Standard Deviation 45.3) percentage change was observed.
- Change in WOMAC - Physical Function Score:
- A mean of -51.20 (Standard Deviation 32.5) percentage change was observed.
- A mean of -47.8 (Standard Deviation 47.8) percentage change was observed.
- A mean of -49.90 (Standard Deviation 35.4) percentage change was observed.
What this means
The results from this pilot trial suggest that geniculate artery embolization may offer significant improvements across multiple domains for patients with mild to moderate knee osteoarthritis. The observed mean reductions in WOMAC pain, stiffness, and physical function scores, as well as VAS pain ratings, indicate potential clinical benefits. As a single-arm pilot study with a small enrollment of 38 participants, these findings demonstrate feasibility and warrant further investigation in larger, controlled trials to confirm efficacy and safety compared to existing treatments or placebo.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04379700, titled "Geniculate Artery Embolization for Treatment of Osteoarthritis", were posted on 2025-05-31 on clinicaltrials.gov.