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Procedure

Patients with Post TKA Knee Pain 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Score from Baseline to Month 6

Secondary outcome measures

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

Incidence of Successful Selective Catheterization of Target Genicular Artery

Incidence of Synovitis

+4 more

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,469 Total Patients Enrolled

Bedros Taslakian, MDPrincipal InvestigatorNYU Langone Health

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"According to the information provided on clinicaltrials.gov, this research study is actively pursuing participants. It was initially published on April 5th, 2024 and underwent its most recent revision on the same date."

Answered by AI

Can individuals who have not yet reached the age of 18 participate in this research?

"To partake in this research study, individuals must be between 30 and 85 years old."

Answered by AI

What is the current number of participants being recruited for this research investigation?

"Yes, the details on clinicaltrials.gov confirm that recruitment for this trial is ongoing. The study was initially published on April 5th, 2024 and most recently revised on the same date. This research endeavor seeks to enroll a total of 40 participants at one designated site."

Answered by AI

What specific criteria should be considered when selecting participants for this research endeavor?

"This research study aims to enroll 40 individuals aged between 30 and 85 experiencing knee discomfort. Eligible participants must meet the subsequent conditions: enduring knee pain unresponsive to traditional therapies for a minimum of 9 months after undergoing total knee arthroplasty for osteoarthritis, Moderate to severe knee pain rated at ≥40 mm on the visual analog scale (VAS), Capable, agreeable, and mentally fit to give informed consent and fulfill survey requests in English. The questionnaires used in this investigation are authenticated in English."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty

2024. "Geniculate Artery Embolization for Treatment of Persistent Knee Pain Post Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06134817.

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