Artery Embolization for Knee Pain

N/A

Recruiting

Led By Bedros Taslakian, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 24 post-gae procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new treatment called transcatheter arterial embolization for patients with ongoing knee pain after knee replacement surgery. The treatment involves blocking certain arteries in the knee. Patients will be followed

Who is the study for?

This trial is for individuals who have had knee replacement surgery (TKA) but still experience moderate to severe pain that hasn't improved with standard treatments for at least 9 months. Participants must be able to understand and fill out study questionnaires in English.

What is being tested?

The trial is testing a procedure called geniculate artery embolization (GAE) using Embozene Color-Advanced Microspheres, which aims to reduce persistent knee pain after TKA. It's a single-arm study without a placebo group, tracking patient outcomes for up to 24 months post-procedure.

What are the potential side effects?

Potential side effects of the GAE procedure may include discomfort at the catheter insertion site, bruising or bleeding, allergic reaction to materials used during embolization, and temporary increased knee pain following the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 24 post-gae procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 24 post-gae procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 24 post-gae 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 Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score from Baseline to Month 6

Secondary study objectives

Incidence of Successful Embolization from at least One Feeding Artery of the Knee Joint

Incidence of Synovitis

KOOS Symptoms Score

+3 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: Patients with Post TKA Knee PainExperimental Treatment1 Intervention

Patients with persistent knee pain resistant to conservative management for at least 9 months after total knee arthroplasty (TKA) will receive geniculate artery embolization (GAE) using Embozene Color-Advanced Microspheres. Treatment will be completed during one interventional session.

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