Geniculate Artery Embolization for Osteoarthritis, Knee

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteoarthritis, Knee+3 More
Geniculate Artery Embolization - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to treat osteoarthritis that doesn't involve surgery. They will compare it to the standard of care to see if it is better.

Eligible Conditions
  • Osteoarthritis, Knee
  • Knee
  • Arthrosis
  • Arthritis

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: baseline, 1 month, 6 months, 12 months

12 months
Feasibility as Assessed by Protocol Adherence
Feasibility as Assessed by Recruitment Rate
Safety as Assessed by Grade 3-4 Adverse events
Month 12
C-Reactive Protein Concentration
Erythrocyte Sedimentation Rate
IL-6 Concentration
Matrix Metalloprotinase 1 Concentration
Prostaglandin E2 Concentration
Vascular Endothelial Growth Factor Concentration
Month 12
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care
1 of 2
GAE + Standard of Care
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Geniculate Artery Embolization · No Placebo Group · N/A

GAE + Standard of Care
Device
Experimental Group · 1 Intervention: Geniculate Artery Embolization · Intervention Types: Device
Standard of CareNoIntervention Group · 1 Intervention: Standard of Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Geniculate Artery Embolization
2018
N/A
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 month, 6 months, 12 months

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,239 Previous Clinical Trials
1,460,622 Total Patients Enrolled
3 Trials studying Osteoarthritis, Knee
131 Patients Enrolled for Osteoarthritis, Knee
Jafar Golzarian, MDPrincipal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
379 Total Patients Enrolled
Reza Talaie, MDPrincipal InvestigatorUniversity of Minnesota

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have symptomatic osteoarthritis of the knee, and radiographic evidence of OA in the same knee.
You have a radiograph of the knee that shows one or more of the following: a.
You are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure.
You are willing to comply with regular follow-up during the 12 month follow-up period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.