Geniculate Artery Embolization for Treatment of Osteoarthritis

  • STATUS
    Recruiting
  • End date
    Jun 18, 2023
  • participants needed
    23
  • sponsor
    NYU Langone Health
Updated on 18 February 2021

Summary

Single-arm, single-center, no sham or placebo, prospective pilot trial designed to evaluate the feasibility and safety of transcatheter arterial embolization in patients with mild to moderate radiographic knee OA. Eligible participants will receive geniculate artery embolization using Embozene Color-Advanced Microspheres. Patients will be followed up for a total of 12 months.

Description

The current study seeks to determine whether transcatheter arterial embolization of abnormal neovasculature arising from the genicular arterial branches is safe and effective in the treatment of mild-to-moderate knee OA.

Details
Condition Arthritis, Osteoarthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), degenerative arthritis
Treatment Transcatheter arterial embolization, Embozene™ Microspheres
Clinical Study IdentifierNCT04379700
SponsorNYU Langone Health
Last Modified on18 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 30 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Arthritis and Arthritic Pain (Pediatric) or Arthritis or Arthritis and Arthritic Pain or degenerative arthritis or Osteoarthritis?
Do you have any of these conditions: Arthritis and Arthritic Pain or Arthritis or Arthritis and Arthritic Pain (Pediatric) or Osteoarthritis or degenerative arthritis?
Do you have any of these conditions: Arthritis and Arthritic Pain (Pediatric) or Arthritis or Osteoarthritis or degenerative arthritis or Arthritis and Arthritic Pain?
Do you have any of these conditions: Arthritis or Osteoarthritis or Arthritis and Arthritic Pain (Pediatric) or degenerative arthritis or Arthritis and Arthritic Pain?
Do you have any of these conditions: degenerative arthritis or Osteoarthritis or Arthritis and Arthritic Pain or Arthritis or Arthritis and Arthritic Pain (Pediatric)?
-75 years of age of any gender
Kellgren-Lawrence Grade 2, or 3 knee OA on most recent knee radiograph obtained within 6 months of screening visit and
Knee pain resistant to conservative treatment for at least 3 months
Moderate to severe knee pain: pain VAS 40 mm with 0 representing 'no pain' and 100 'the worst pain imaginable
Willing, able, and mentally competent to provide informed consent

Exclusion Criteria

< 30 or > 75 years of age or
Active systemic or local knee infection or
Active malignancy or
Life expectancy less than 12 months or
Prior ipsilateral knee surgery excluding arthroscopic surgery more than 6 months ago or
Ipsilateral knee intra-articular injection in the last 3 months or
Kellgren-Lawrence Grade 1 or 4 knee OA on knee radiograph or
Rheumatoid arthritis, spondyloarthropathies, crystal disease, gout, pseudogout, or lupus
Pregnant during the study period or
Renal dysfunction as defined by serum creatinine >1.6 dl/mg or eGFR <60 obtained within 30 days of procedure or
Body weight greater than 200 Kg or
Uncorrectable coagulopathy (platelet count < 50,000, international normalized ratio >1.5 within 30 days of procedure; or
Known history of contrast allergy resulting in anaphylaxis or
Known significant arterial atherosclerosis that would limit selective angiography
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