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NCT Number: NCT07361198

Percutaneous Transcatheter Genicular Embolization in Osteoarthritis

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

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masarykova nemocnice v Ústí nad Labem

Ústí nad Labem, 40011, Czechia

Location status: Recruiting

Location contact

Patrik Matras

PRINCIPAL_INVESTIGATOR

Pavol Vigláš

CONTACT

[email protected]

775733343

Pavol Vigláš

SUB_INVESTIGATOR

Tomas Novotny

SUB_INVESTIGATOR

Vojtěch Smolka

SUB_INVESTIGATOR

CONTACT

[email protected]

About this study

This is a prospective, single-center, interventional pilot study designed to assess a catheter-based endovascular technique targeting pathological vascular changes associated with chronic knee pain. The intervention focuses on selective embolization of abnormal synovial and periarticular arterial branches identified by angiographic imaging as areas of increased perfusion related to inflammatory activity.

The procedure is performed in an angiography suite under local anesthesia. Vascular access is obtained via the common femoral artery, followed by selective catheterization of the arterial branches supplying the knee joint. Digital subtraction angiography is used to visualize hypervascular regions, typically seen as focal contrast enhancement ("blush"). These regions are considered targets for treatment. Embolization is carried out using a temporary embolic suspension administered through a microcatheter until adequate flow reduction in the target vessels is achieved, while preserving normal surrounding circulation.

Participants undergo standardized clinical and imaging assessments before the intervention and during scheduled follow-up visits over a two-year period. Follow-up evaluations are intended to capture longitudinal changes in clinical status and to monitor for any procedure-related adverse events. The study emphasizes procedural safety, technical feasibility, and post-interventional monitoring rather than comparison with alternative therapies.

Data collected during the study are analyzed using descriptive and paired statistical methods appropriate for an exploratory pilot design. The study is conducted in accordance with applicable ethical standards and regulatory requirements, with particular attention to patient safety, data protection, and transparency of reporting. The findings are expected to provide technical and clinical insights to inform future larger-scale studies and potential integration of this approach into clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Ability to understand the study procedures and provide written informed consent _ Willingness and ability to comply with the study procedures and follow-up schedule

Exclusion criteria

  • 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
  • Severe renal impairment
  • History of fibromyalgia or other generalized chronic pain syndromes that may confound pain assessment
  • Pregnancy or breastfeeding

Treatment and study plan

Genicular Artery Embolisation

Procedure

The 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.

Primary outcomes

  1. VAS (Visual Analog Scale) score

    Time frame: In 1st, 3rd, 6th, 12th and 24th month after the procedure.

    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.

  2. WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) score

    Time frame: In 1st, 3rd, 6th, 12th and 24th month after the procedure.

    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).

  3. KOOS (Knee Injury and Osteoarthritis Outcome Score) score

    Time frame: In 1st, 3rd, 6th, 12th and 24th month after the procedure.

    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.

Secondary outcomes

  1. Analgetics use

    Time frame: In 1st, 3rd, 6th, 12th and 24th month after the procedure.

    Amount of analgesic use in mg per day

Study contacts

Contact information is provided by the study sponsor or research team.

Patrik Matras, MUDr.

CONTACT

[email protected]

+420 604 753 473

Pavol Viglas

CONTACT

[email protected]

+420 775 733 343

Sponsors and collaborators

Lead sponsor

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jan 22, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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