Percutaneous Transcatheter Genicular Embolization in Osteoarthritis

NCT07361198 | Recruiting

• 1 other identifier: GENIEMB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteo Arthritis of the Knee; Osteoarthitis; Osteoarthritic Knee Pain

Keywords

genicular artery embolisation; osteoarthritis; MSK embolisation

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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).

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

• 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.

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

Secondary Outcomes (1)

• Analgetics use

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

Study Arms (1)

Patients treated with genicular artery embolisation

EXPERIMENTAL

Procedure: genicular artery embolisation

Interventions

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.

Patients treated with genicular artery embolisation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Masarykova nemocnice v Ústí nad Labem

Ústí nad Labem, 40011, Czechia

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Patrik Matras, MUDr.

CONTACT

+420 604 753 473; patrik.matras@kzcr.eu

Pavol Viglas

CONTACT

+420 775 733 343; papo.viglas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 22, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 23, 2026
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Individual participant data will be available for sharing beginning after publication of the primary study results and up to five (5) years following completion of the study.
• Access Criteria: The data will be made available upon reasonable request to qualified researchers for scientifically sound proposals. Requests should include a brief description of the research objectives and a statistical analysis plan and will be reviewed by the principal investigator.

Locations

CZ (1)