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Knee Artery Embolization for Osteoarthritis

N/A
Recruiting
Led By Andre Uflacker, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
Patients without contraindication to MRI imaging with gadolinium-based contrast.
Must not have
Rheumatoid Arthritis or Gout
Hemarthrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether MRI can be used to evaluate the effect of knee artery embolization for knee osteoarthritis.

Who is the study for?
This trial is for adults aged 25-90 with knee osteoarthritis, who've tried non-surgical pain treatments like injections or NSAIDs. They must be able to consent and have no MRI contraindications, severe kidney issues, malignancy in the knee, rheumatoid arthritis/gout, recent septic arthritis, or past major knee surgery.
What is being tested?
The study tests if geniculate artery embolization reduces pain from knee osteoarthritis and improves quality of life. It involves initial/follow-up clinic visits, two MRIs (one before and one six months after treatment), and participants tracking their pain levels.
What are the potential side effects?
Possible side effects include discomfort at the embolization site, allergic reactions to contrast material used in MRI scans (gadolinium), changes in kidney function due to contrast agents, and typical risks associated with minimally invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have knee pain due to arthritis, confirmed by an X-ray.
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I can safely undergo MRI scans with contrast.
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I can understand and agree to the study's terms on my own.
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I am between 25 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Rheumatoid Arthritis or Gout.
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I have bleeding within my joints.
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My knee cancer is confirmed.
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I have had knee surgery before.
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My kidney function is low, with a GFR under 30ml/min.
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I am not pregnant nor planning to become pregnant during the study.
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I have severe artery disease in my legs that prevents certain artery procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis
Change in Whole-Organ Magnetic Resonance Scoring (WORMS)
Change in enhancement time intensity curves obtained from CE-MRI
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GAE and MRI treatment armExperimental Treatment2 Interventions
GAE is geniculate artery embolization.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
977 Previous Clinical Trials
7,400,975 Total Patients Enrolled
BayerIndustry Sponsor
2,275 Previous Clinical Trials
25,539,387 Total Patients Enrolled
4 Trials studying Osteoarthritis
1,288 Patients Enrolled for Osteoarthritis
Andre Uflacker, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

geniculate artery embolization Clinical Trial Eligibility Overview. Trial Name: NCT05349682 — N/A
Osteoarthritis Clinical Trial 2023: geniculate artery embolization Highlights & Side Effects. Trial Name: NCT05349682 — N/A
Osteoarthritis Research Study Groups: GAE and MRI treatment arm
geniculate artery embolization 2023 Treatment Timeline for Medical Study. Trial Name: NCT05349682 — N/A
~4 spots leftby Dec 2025
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