Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
NCT05423587

Genicular Artery Embolisation for Knee Osteoarthritis II

Led by Varian, a Siemens Healthineers Company · Updated on 2024-12-03

110

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.

CONDITIONS

Official Title

Genicular Artery Embolisation for Knee Osteoarthritis II

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is willing and able to give informed consent for participation in the study.
  • Participants aged 45 years or above.
  • Grade 1-3 knee osteoarthritis on X-ray as per Kellgren-Lawrence Grading Scale.
  • Knee pain for at least 3 months resistant to conservative non-surgical treatment (e.g., physiotherapy, steroid injections, weight loss programs, PRP injections).
  • Able to lie flat for at least 6 hours, assessed by how participants sleep and any difficulties like breathlessness or back pain.
  • Minimum score of 50 on baseline 0 - 100 visual analog scale (VAS) for pain.
Not Eligible

You will not qualify if you...

  • Rheumatoid arthritis or infectious arthritis.
  • Severe knee osteoarthritis (grade 4 on X-ray as per Kellgren-Lawrence Grade).
  • Renal impairment with estimated glomerular filtration rate (eGFR) less than 45.
  • Bleeding disorders or bleeding risk such as patients on warfarin that cannot be stopped easily, or uncorrectable bleeding diathesis (INR>1.6, platelets <50,000).
  • Requires oxygen when walking.
  • Low life expectancy less than 1 year.
  • Communication difficulties due to language barriers.
  • Contraindication to MRI.
  • Known allergies to barium sulfate, 3-aminopropyltrialkoxysilane, polyphosphazene, or intravenous radiopaque contrast agent.
  • History of peripheral arterial disease with intermittent claudication or rest pain.
  • Pregnancy or positive pregnancy test.
  • Any other significant disease or disorder that may increase risk or affect study results as judged by the recruiting physician.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom, RG1 5AN

Actively Recruiting

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Research Team

H

Heike S Hausen, MD

CONTACT

K

Kate Pietrovito

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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