Percutaneous Transcatheter Genicular Embolization in Osteoarthritis
Phase: NA
Conditions: Osteoarthritic Knee Pain, Osteo Arthritis of the Knee, Osteoarthitis
Sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

 
 
 
 
 
 
 
 
 
 
 
 
 
Cover Page for ClinicalTrials.gov  
Document: Study protocol 
Study Title: Percutaneous Transcatheter Embolization of Knee Arteries in 
Osteoarthrosis  
Document Date: December 29, 2025  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Percutaneous transcatheter embolization of knee arteries in 
osteoarthritis 
Study, protocol and methodology 
 
1. Introduction and aim of the study 
Knee osteoarthritis (gonarthrosis) is a chronic degenerative disease characterized by the gradual loss of articular 
cartilage, remodeling of the subchondral bone and the development of chronic pain, which significantly affects 
the quality of life of patients. Current treatment options include conservative therapy, pharmacological 
treatment, injections of hyaluronic acid, corticosteroids and, in advanced cases, total knee arthroplasty. 
However, in some patients, pain persists even after TEP, or they are not suitable for TEP. In recent years, 
targeted endovascular embolization of synovial arteries supplying the knee joint has emerged as a promising 
method. 
The aim of this prospective, interventional clinical study is to evaluate the efficacy and safety of percutaneous 
microcatheter embolization of knee arteries using a temporary embolization material (Imipenem/Cilastatin) in 
patients with advanced knee osteoarthritis or chronic pain after total knee arthroplasty. 
2. Overview of current knowledge 
Endovascular embolization of the knee joint is a newly developing minimally invasive method that aims to 
reduce hypervascularization and inflammatory activity in the area of the synovial membrane. Studies published 
mainly in Japan, South Korea and the USA in 2019–2024 have shown a significant reduction in pain and 
improvement in the functional capacity of the joint in patients with gonarthrosis grade II–IV according to 
Kellgren-Lawrence. The mechanism of action is based on the reduction of pathological neovascularization and 
the interruption of afferent nociceptive pathways. 
3. Hypothesis and scientific questions 
Hypothesis: Percutaneous embolization of knee arteries using a microcatheter is a safe and effective method that 
leads to pain reduction and improved knee joint function in patients with grade II–IV osteoarthritis or chronic 
pain after TEP. 
Scientific questions: 
• What is the extent of pain relief after the procedure as measured by VAS? 
• Is there an improvement in the functional capacity of the knee joint according to WOMAC and KOOS scores? 
• What is the technical success rate of the intervention and the incidence of complications associated with the 
procedure? 
4. Study design and plan 
This is a single-center, prospective, open-label pilot study with a planned number of 20 patients. Patients will be 
followed for 24 months. Check-ups will be performed after 1, 3, 6, 12 and 24 months. 
5. Inclusion and exclusion criteria 
Inclusion criteria: 
• age 40–80 years 
• clinically and radiologically confirmed gonarthrosis grade II–IV according to Kellgren-Lawrence 
• patients with pain unresponsive to conservative treatment or with persistent pain after arthroplasty 
• patients unsuitable for arthroplasty of the knee joint 
Exclusion criteria: 
• active infection 
• coagulopathy 
• peripheral arterial disease 
• allergy to contrast medium 
• renal insufficiency  
• history of fibromyalgia 
• patient's refusal 
6. Description of the intervention 
The procedure will be performed in the angiography room under local anesthesia. After puncture of the common 
femoral artery, a microcatheter will be inserted into the arterial branches supplying the knee joint and DSA will 
be performed. The target lesions have a typical "blush" appearance representing pathological 
neovascularization. Embolization will be performed by applying a suspension of Imipenem/Cilastatin dissolved 
in saline with a contrast agent until the flow in the target branch is stopped. 
7. Evaluation of efficacy and safety 
The primary endpoint is the change in pain intensity according to the visual analogue scale (VAS) between 
baseline and 6 months after the procedure. Secondary endpoints include change in WOMAC score, KOOS 

score, reduction in analgesic use, improvement in range of motion and quality of life. Safety will be assessed by 
monitoring complications (hematoma, pseudoaneurysm, infection, allergic reaction, paresthesia, transient skin 
blanching in the embolization area). 
8. Monitored parameters and evaluation methods 
• VAS – visual analogue scale of pain 
• WOMAC score – functional assessment of the knee joint 
• KOOS score – pain, symptoms, daily activities, sports and recreation, quality of life 
• Use of analgesics (mg/day) 
• Clinical examination (swelling, range of motion, stability) 
• Imaging methods: knee X-ray, or MRI as indicated 
9. Statistical analysis 
Data will be processed using descriptive statistics. To compare parameters before and after the procedure, paired 
t-test or Wilcoxon test will be used depending on the data distribution. Significance will be determined at the p 
< 0.05 level. 
10. Ethical aspects 
The study will be conducted in accordance with the Declaration of Helsinki and the applicable laws of the 
Czech Republic. Each participant will provide written informed consent. The ethics committee will be informed 
about the progress of the study. Patients may withdraw at any time without giving a reason and without impact 
on further treatment. 
11. Protection of personal data 
All data will be anonymized and stored in accordance with EU Regulation 2016/679 (GDPR). Only the study 
investigators will have access to the identifying data. After the study is completed, the personal data will be 
destroyed. 
12. Schedule and organization 
Planned duration: January 2026 – December 2027. Place of implementation: Radiology and Orthopedic Clinic 
of Masaryk Hospital in Ústí nad Labem, oz, Regional Health Company Research team: MUDr. Patrik Matras 
(principal investigator), MUDr. Pavol Vigláš, MUDr. Vojtěch Smolka, MUDr. Tomáš Novotný, PhD. MBA. 
13. Conclusion 
This protocol describes the design of a prospective clinical trial aimed at evaluating the effectiveness and safety 
of percutaneous knee artery embolization in osteoarthritis. We assume that the results will contribute to 
expanding treatment options for patients with gonarthrosis and chronic pain after TEP and will enable the 
introduction of a minimally invasive method into routine clinical practice.