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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post procedure
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
933 Previous Clinical Trials
7,394,623 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,765 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

Frequently Asked Questions

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

Are there any age limitations on participant recruitment for this research?

"According to the guidelines, individuals eligible for this trial must be at least 25 years old and no older than 90."

Answered by AI

What qualifications must a person possess to be eligible for this clinical research?

"This clinical investigation is specifically searching for 12 individuals suffering from osteoarthritis in their knee or knees, aged between 25 and 90. To be eligible to participate, the following criteria must all be met: Age requirement of 25 - 90 years old; Osteoarthritic-related pain being represented as a Kellgren-Lawrence grade 1-3 on a weight bearing radiography report; Suffering at least one month's worth of non surgical therapy such as joint injections, NSAID tablets or opioid related analgesia; Ability to give informed consent (as this study will involve data collection about pain); No contraindications against MRI"

Answered by AI

Are there any open slots available for participants in this clinical research?

"Affirmative. According to the clinicaltrials.gov website, this medical trial, which was first advertised on October 1st 2022 is still actively recruiting participants. There are 12 spots available in one location for potential patients."

Answered by AI

How many research participants have been invited to participate in this trial?

"Affirmative. Clinicaltrials.gov has records indicating that the trial, which was initially posted on October 1st 2022, is actively enrolling participants. Across a single medical facility 12 patients need to be recruited for this study."

Answered by AI

Who else is applying?

What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Bayer OA Knee Pain Pilot
Antony Gayed 2022. "Bayer OA Knee Pain Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349682.
All > Osteoarthritis Knee > Knee Pain
~2 spots leftby Oct 2024
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