Osteoarthritis, KneeNCT05349682
Bayer OA Knee Pain Pilot
A study testing dynamic contrast enhanced MRI and geniculate artery embolization in people with Osteoarthritis, Knee, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- dynamic contrast enhanced MRI and geniculate artery embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 to 90
- Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
- One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
- Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
- Patients without contraindication to MRI imaging with gadolinium-based contrast.
Who cannot join
- Anaphylaxis to gadolinium or iodinated contrast media
- Impaired renal function with GFR <30ml/min
- Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
- Active septic arthritis of the symptomatic knee within 2 months of screening
- Malignancy of the involved knee
- Rheumatoid Arthritis or Gout
Show all 9Show fewer
- Prior knee surgery
- Hemarthrosis
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- dynamic contrast enhanced MRI, geniculate artery embolization
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic contrast enhanced MRIDiagnostic test
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).
geniculate artery embolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| GAE and MRI treatment arm | Experimental | GAE is geniculate artery embolization. Receives: Diagnostic Test: dynamic contrast enhanced MRI; Procedure: geniculate artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in enhancement time intensity curves obtained from CE-MRI
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)
Measured: change from baseline at 6 month post procedure
Change in Whole-Organ Magnetic Resonance Scoring (WORMS)
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.
Measured: change from baseline at 6 month post procedure
Change in Multicenter Osteoarthritis Study (MOST) grading system for synovitis
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.
Measured: change from baseline at 6 month post procedure
Number of participants with 50% reduction in pain scores
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.
Measured: change from baseline at 1 month post procedure
Number of participants with 50% reduction in pain scores
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.
Measured: change from baseline at 6 month post procedure
Number of participants with 50% reduction in pain scores
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.
Measured: change from baseline at 12 month post procedure
Incidence of adverse events associated with GAE
The number of adverse events per participant
Measured: 1 month post procedure
Incidence of adverse events associated with GAE
The number of adverse events per participant
Measured: 6 month post procedure
Incidence of adverse events associated with GAE
The number of adverse events per participant
Measured: 12 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Andre Uflacker, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349682
- Sponsor's protocol ID
- 00113621
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will share anonymized DCE-MRI data with consulting radiologists.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Geniculate Arterial Embolization: Treatment and Monitoring of Response
- ClinicalTrials.gov ID
- NCT05349682
- Acronym / sponsor ID
- 00113621
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAE and MRI treatment arm | Experimental | Diagnostic Test: dynamic contrast enhanced MRI, Procedure: geniculate artery embolizationGAE is geniculate artery embolization. |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 25 to 90
- Symptomatic osteoarthritis of one or both knees, with Kellgren-Lawrence grade 1-3 assessed by weight-bearing knee radiography, including post-traumatic osteoarthritis
- One or more months of non-surgical therapy for knee pain such as joint injections, oral NSAIDs, or opioid analgesia
- Subjects able to provide informed consent. As this is a study of pain, patients must be able to consent for themselves.
- Patients without contraindication to MRI imaging with gadolinium-based contrast.
Key exclusion criteria (9 listed)
- Anaphylaxis to gadolinium or iodinated contrast media
- Impaired renal function with GFR <30ml/min
- Severe atherosclerotic disease of the lower extremity precluding percutaneous angiographic access to the involved geniculate artery(ies)
- Active septic arthritis of the symptomatic knee within 2 months of screening
- Malignancy of the involved knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic contrast enhanced MRIAn 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). | Diagnostic test | GAE and MRI treatment arm |
| geniculate artery embolizationThe 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. | Procedure or surgery | GAE and MRI treatment arm |
Primary outcome
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 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 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.
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.
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.
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.
Incidence of adverse events associated with GAE
Time frame: 1 month post procedure
The number of adverse events per participant
Incidence of adverse events associated with GAE
Time frame: 6 month post procedure
The number of adverse events per participant
Incidence of adverse events associated with GAE
Time frame: 12 month post procedure
The number of adverse events per participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. The study team will share anonymized DCE-MRI data with consulting radiologists.
Related trials for Osteoarthritis, Knee
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Not yet recruiting
Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes
Knee Osteoarthritis
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Uflacker, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic contrast enhanced MRI and geniculate artery embolization in people with Osteoarthritis, Knee, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in enhancement time intensity curves obtained from CE-MRI (time frame: change from baseline at 6 month post procedure). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.