Bayer OA Knee Pain Pilot

July 21, 2026 updated by: Medical University of South Carolina

Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response

The objective of this study is to investigate if MRI can be used to evaluated effect of knee artery embolization for knee osteoarthritis. Participants be evaluated in clinic, obtain a knee MRI, undergo embolization of the symptomatic knee, and follow up in clinic at 1, 6, and 12 months after embolization. A second MRI is obtained 6 months after embolization. Participants will keep a record of their pain level and treatment and answer questionnaires at each visit.

In addition, this study aims to determine the effects of knee artery embolization on the amount of opioid (pain reliever drugs) needed to manage osteoarthritis-associated pain and change in quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 25 to 90
  2. Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
  3. One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
  4. Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
  5. Patients without contraindication to MRI imaging with gadolinium-based contrast.

Exclusion Criteria:

  1. Anaphylaxis to gadolinium or iodinated contrast media
  2. Impaired renal function with GFR <30ml/min
  3. Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
  4. Active septic arthritis of the symptomatic knee within 2 months of screening
  5. Malignancy of the involved knee
  6. Rheumatoid Arthritis or Gout
  7. Prior knee surgery
  8. Hemarthrosis
  9. Females who are pregnant or plan to become pregnant during the study. All participants able to become pregnant will be administered a urine pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GAE and MRI treatment arm
GAE is geniculate artery embolization.
Diagnostic test: dynamic contrast enhanced MRI
An MRI study of the knee will be done to check the degree of osteoarthritis and blood flow to the affected knee. This scan will take about 1-2 hour(s).
Procedure: geniculate artery embolization
The physician will perform a diagnostic angiography, where they will take pictures of vessels near the knee that will be treated. Once the artery to be treated is identified, the doctor will guide a thin wire called a microwire, and a plastic tube called a microcatheter to the targeted artery, and more pictures of vessels at the knee will be taken. This picture will be used to see if there are any abnormal vessels at the knee, such as abnormal blood flow, abnormal vessel connections (between the veins and arteries), or new blood vessel growth. Once the targeted artery at the knee is confirmed, the doctor will inject enough particle embolic (Embozene) to slow or stop the blood flow in the geniculate artery. Once all vessels are treated, a final angiogram (pictures of blood vessels) will be performed to ensure that the blood flow has slowed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in enhancement time intensity curves obtained from CE-MRI
Time Frame: change from baseline at 6 month post procedure
To evaluate the effects of particle embolization on knee osteoarthritis progression using enhancement time intensity curves obtained from CE-MRI (Contrast Enhanced Magnetic Resonance Imaging)
change from baseline at 6 month post procedure
Change in Whole-Organ Magnetic Resonance Scoring (WORMS)
Time Frame: change from baseline at 6 month post procedure
To evaluate the effects of particle embolization on knee osteoarthritis progression using the WORMS scoring system. The higher the score, the worse the OA is. The scoring ranges from 0-332.
change from baseline at 6 month post procedure
Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis
Time Frame: change from baseline at 6 month post procedure
To evaluate the effects of particle embolization on knee osteoarthritis progression using the MOST grading system for synovitis. The higher the score, the worse the synovial inflammation is. The scoring ranges from 0-13. 0-4 normal or equivocal synovitis, 5-8 mild synovitis, 9-12 moderate synovitis, and 13 or greater is severe synovitis.
change from baseline at 6 month post procedure
Number of participants with 50% reduction in pain scores
Time Frame: change from baseline at 1 month post procedure
To determine the effects of geniculate artery embolization (GAE) on opioid requirements for managing OA associated pain. Assess pain using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS). WOMAC is scored from 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores indicate worse pain, stiffness, and function limitation. KOOS score is from 0-100, 0 being extreme problems and 100 being no problems.
change from baseline at 1 month post procedure
Number of participants with 50% reduction in pain scores
Time Frame: change from baseline at 6 month post procedure
To determine the effects of geniculate artery embolization (GAE) on opioid requirements for managing OA associated pain. Assess pain using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS). WOMAC is scored from 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores indicate worse pain, stiffness, and function limitation. KOOS score is from 0-100, 0 being extreme problems and 100 being no problems.
change from baseline at 6 month post procedure
Number of participants with 50% reduction in pain scores
Time Frame: change from baseline at 12 month post procedure
To determine the effects of geniculate artery embolization (GAE) on opioid requirements for managing OA associated pain. Assess pain using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS). WOMAC is scored from 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. Higher scores indicate worse pain, stiffness, and function limitation. KOOS score is from 0-100, 0 being extreme problems and 100 being no problems.
change from baseline at 12 month post procedure
Incidence of adverse events associated with GAE
Time Frame: 1 month post procedure
The number of adverse events per participant
1 month post procedure
Incidence of adverse events associated with GAE
Time Frame: 6 month post procedure
The number of adverse events per participant
6 month post procedure
Incidence of adverse events associated with GAE
Time Frame: 12 month post procedure
The number of adverse events per participant
12 month post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andre Uflacker, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00113621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study team will share anonymized DCE-MRI data with consulting radiologists.

IPD Sharing Time Frame

duration of the study

IPD Sharing Access Criteria

The data will only be shared via encrypted email or encrypted cloud repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings