Percutaneous Transcatheter Genicular Embolization in Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorMasarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
About this trial
This clinical study investigates a minimally invasive treatment called percutaneous transcatheter embolization of knee arteries for patients with chronic knee pain caused by advanced knee osteoarthritis or persistent pain after total knee replacement. Osteoarthritis of the knee is a common degenerative condition that can lead to long-term pain, reduced mobility, and decreased quality of life, and some patients do not achieve sufficient relief with standard treatments.
The study is based on the hypothesis that targeted embolization of small arteries supplying the inflamed tissues of the knee can safely reduce abnormal blood flow associated with inflammation, leading to pain relief and improved knee function. During the procedure, a thin catheter is guided through the blood vessels to the affected area of the knee, where a temporary embolic agent is administered to reduce pathological blood supply.
The aim of the study is to evaluate the safety and effectiveness of this procedure by assessing changes in pain intensity, knee function, and quality of life over a follow-up period of up to 24 months. The results of this study may help determine whether this minimally invasive approach can offer a new treatment option for patients who have limited alternatives for managing chronic knee pain
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 40 to 80 years
Clinical symptoms consistent with chronic knee pain
Radiographically confirmed knee osteoarthritis of Kellgren-Lawrence grade II-IV or persistent knee pain following total knee arthroplasty
Insufficient pain relief after standard conservative treatment (e.g., pharmacological therapy, physical therapy, or injections)
Disqualifiers
Active local or systemic infection
Known coagulation disorders or ongoing anticoagulation that cannot be safely interrupted
Significant peripheral arterial disease affecting the lower limbs
Known allergy or contraindication to iodinated contrast agents
Trial design
Design model
Single group
Treatments tested in this trial
genicular artery embolisation
Procedure/SurgeryThe procedure will be performed in the angiography room under local anesthesia. After puncturing 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 flow in the target branch is stopped.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients treated with genicular artery embolisationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
VAS (Visual Analog Scale) score
A VAS score for knee pain uses a 0-10 scale, where 0 means no pain, and 10 means the worst imaginable pain, helping quantify intensity, often categorized as mild (1-3), moderate (4-6), and severe (7-10) to assess pain levels or treatment effectiveness.
Time frame
In 1st, 3rd, 6th, 12th and 24th month after the procedure.2
WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) score
The total WOMAC score can range from 0 to 96, with a higher number indicating greater disease severity. The final number is calculated by adding up the points in three separate subscales that assess pain (0-20 points), stiffness (0-8 points), and knee joint function (0-68 points).
Time frame
In 1st, 3rd, 6th, 12th and 24th month after the procedure.3
KOOS (Knee Injury and Osteoarthritis Outcome Score) score
The KOOS score is a patient-completed questionnaire assessing knee health and function across five areas: Pain, Symptoms (stiffness/swelling), Activities of Daily Living (ADL), Sport \& Recreation, and Quality of Life (QoL). It uses a 0-100 scale (0=worst, 100=best) to track outcomes after knee injuries or arthritis, helping evaluate treatment effectiveness.
Time frame
In 1st, 3rd, 6th, 12th and 24th month after the procedure.Secondary outcomes
1
Analgetics use
Amount of analgesic use in mg per day
Time frame
In 1st, 3rd, 6th, 12th and 24th month after the procedure.Sponsors and contacts
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Source ClinicalTrials.gov