Percutaneous Transcatheter Genicular Embolization in Osteoarthritis

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура genicular artery embolisation
  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.

Первичные конечные точки

• VAS (Visual Analog Scale) score [Срок оценки: In 1st, 3rd, 6th, 12th and 24th month after the procedure.]
• WOMAC ( Western Ontario and McMaster Universities Osteoarthritis Index) score [Срок оценки: In 1st, 3rd, 6th, 12th and 24th month after the procedure.]
• KOOS (Knee Injury and Osteoarthritis Outcome Score) score [Срок оценки: In 1st, 3rd, 6th, 12th and 24th month after the procedure.]

Вторичные конечные точки (1)

• Analgetics use [Срок оценки: In 1st, 3rd, 6th, 12th and 24th month after the procedure.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• Masarykova nemocnice v Ústí nad Labem — Ústí nad Labem

Публикации

• Fleckenstein FN, Maleitzke T, Auer TA, Bolle P, Gebauer B, Winkler T, Collettini F. Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. Radiology. 2025 Jul;316(1):e243648. doi: 10.1148/radiol.243648. No abstract available. PMID 40693933
• Bagla S, Piechowiak R, Sajan A, Orlando J, Hartman T, Isaacson A. Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. J Vasc Interv Radiol. 2022 Jan;33(1):2-10.e2. doi: 10.1016/j.jvir.2021.09.019. Epub 2021 Oct 2. PMID 34610422
• Okuno Y, Korchi AM, Shinjo T, Kato S. Transcatheter arterial embolization as a treatment for medial knee pain in patients with mild to moderate osteoarthritis. Cardiovasc Intervent Radiol. 2015 Apr;38(2):336-43. doi: 10.1007/s00270-014-0944-8. Epub 2014 Jul 4. PMID 24993956
• van Zadelhoff TA, Bos PK, Moelker A, Bierma-Zeinstra SMA, van der Heijden RA, Oei EHG. Genicular artery embolisation versus sham embolisation for symptomatic osteoarthritis of the knee: a randomised controlled trial. BMJ Open. 2024 Oct 1;14(10):e087047. doi: 10.1136/bmjopen-2024-087047. PMID 39353688

Идентификаторы

NCT: NCT07361198 · GENIEMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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