Osteo Arthritis KneeNCT04456569
Geniculate Artery Embolization for Osteoarthritis
A study testing Geniculate Artery Embolization in people with Osteo Arthritis Knee and Arthritis, run by University of Minnesota at 1 site in United States.
Trial summary
The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research. Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteo Arthritis Knee, Arthritis, Osteoarthritis
- What is being tested?
- Geniculate Artery Embolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 1 Aug 2027
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 40 - 70 years of age.
- Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude).
- Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months).
- Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
- Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months.
- Willing to comply with regular follow up during the 12 month follow-up period.
- Not a current candidate for partial or total knee arthroplasty.
- WOMAC Score >=6 in at least 2 categories.
Who cannot join
- BMI >35 kg/m2
- Advanced peripheral arterial disease (resting ABI <= 0.9).
- Known significant peripheral arterial disease precluding common femoral catheterization
- Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
- Diabetics with hemoglobin A1C of >9%
- Previous lower extremity embolization
Show all 24Show fewer
- Uncontrolled emotional disorders per patient medical history
- Chronic pain syndrome or currently under a pain contract.
- Anatomic variants involving the lower extremities which would increase the risk of non-target embolization
- Renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
- Abnormal INR (>1.5)
- Platelet count <50x109/L.
- Currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
- Known severe allergy to iodine which cannot be adequately pre-medicated
- Pregnant or intend to become pregnant within 6 months of the procedure
- Contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
- Life expectancy <60 months
- Currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
- Contraindications to medical and physical rehabilitative treatments of OA.
- Advanced atherosclerosis.
- Current or previous lower extremity fistula.
- Rheumatoid arthritis or seronegative arthropathies.
- WOMAC Pain Scale < 6
- Steroid injection in the affected joint within 3 months of screening. I- n investigator assessment, patient is not a candidate for study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Geniculate Artery Embolization for Osteoarthritis: Pilot Study
The need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research.
Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care.
This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.
Read the detailed description
This is a single center, two-arm, open label, pilot study to assess feasibility and safety and obtain a preliminary estimate of efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing conservative presurgical management. The 20 patients will be randomly divided into two groups of 10 in 1:1 allocation. One group will have embolization of the geniculate artery branches and standard of care while the other will have only the standard care. Following the completion of the 10 participants in each arm, a safety and data review will be undertaken (Visit 4 in the GAE group and Visit 2 of the SOC). The data will be assessed regarding the trends between the groups as they relate to KOOS/WOMAC pain scale, MRI / Xray evaluation of OA, and presence of inflammatory biomarkers.
- Conditions
- Osteo Arthritis Knee, Arthritis, Osteoarthritis, Osteoarthritis, Knee
- Being tested
- Geniculate Artery Embolization
- Keywords
- Embolotherapy
- Medical subject headings
- Arthritis, Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geniculate Artery EmbolizationDevice
All patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries. For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee.
| Study group | Role | What they receive |
|---|---|---|
| GAE + Standard of Care | Experimental | Participants in this arm will receive geniculate artery embolization and standard of care. Receives: Device: Geniculate Artery Embolization |
| Standard of Care | No intervention | Participants in this arm will receive standard of care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Assessed by Grade 3-4 Adverse events
Safety will be reported using the combined number of grade 3 and 4 adverse events that occur in each arm.
Measured: 12 months
Secondary outcomes (8)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS measures 5 patient-relevant dimensions, each scored separately:
Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items).
Items are rated on a 5-point Likert scale from 0 (No problems) to 4 (Extreme problems). Dimension scores are calculated as the mean score of the included items divided by 4 and multiplied by 100. Range of subscale scores is 0-100 with higher scores indicating better function.
Measured: baseline, 1 month, 6 months, 12 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Items are rated on a Likert scale of 0 (extreme) to 4 (none). Raw sub-scale scores are normalized to produce percentage scores in accordance with the KOOS by multiplying each score by 100/96. Total scores are a sum of the normalized sub-scales scores and range 0-100, with higher scores indicating better functioning.
Measured: baseline, 1 month, 6 months, 12 months
IL-6 Concentration
Interleukin-6 concentrations will be measured in the serum and joint aspirate and reported in units of pg/ml.
Measured: baseline, 1 month, 12 months
Prostaglandin E2 Concentration
Prostaglandin E2 concentrations will be measured in the serum and joint aspirate and reported in units of pg/ml.
Measured: baseline, 1 month, 12 months
Matrix Metalloprotinase 1 Concentration
Matrix Metalloprotinase 1 concentrations will be measured in the serum and joint aspirate and reported in units of ng/ml.
Measured: baseline, 1 month, 12 months
Vascular Endothelial Growth Factor Concentration
Vascular Endothelial Growth Factor concentrations will be measured in the serum and joint aspirate and reported in units of pg/ml.
Measured: baseline, 1 month, 12 months
C-Reactive Protein Concentration
C-Reactive Protein concentrations will be measured in the serum and reported in units of mg/L.
Measured: baseline, 1 month, 12 months
Erythrocyte Sedimentation Rate
Erythrocyte sedimentation rate will be performed using serum and reported in units of mm/hr.
Measured: baseline, 1 month, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Feb 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Talaie, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456569
- Sponsor's protocol ID
- RAD-2019-27368
- Status last verified
- May 2026
- First submitted
- 29 Jun 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geniculate Artery Embolization for Osteoarthritis: Pilot Study
- ClinicalTrials.gov ID
- NCT04456569
- Acronym / sponsor ID
- RAD-2019-27368
- Conditions
- Osteo Arthritis Knee, Arthritis, Osteoarthritis, Osteoarthritis, Knee
- Keywords
- Embolotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Jul 2020 (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 need for exploration of more definitive and cost effective non-arthroplasty treatments of osteoarthritis (OA) has been demonstrated by the orthopedic and health economic research.
Embolotherapy of neovessels associated with OA joints has been shown to be promising in patients with knee OA. There is a need for level one evidence drawn from randomized clinical trials to prove the safety, feasibility and efficacy of knee embolotherapy compared to standard of care.
This randomized pilot study will assign 10 patients with mild-moderate OA to undergo geniculate artery embolization plus standard of care (defined in this study as: physical therapy and oral anti-inflammatory medications, with a maximum of 1 joint injection at the time of enrollment) and 10 patients to receive only medical standard of care (also having had a maximum of 1 joint injection prior to enrollment). The goal of this pilot study is to obtain preliminary estimates of safety and efficacy of embolotherapy to provide sustained symptom control and modify disease progression in patients with mild to moderate knee OA.
Detailed description
This is a single center, two-arm, open label, pilot study to assess feasibility and safety and obtain a preliminary estimate of efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing conservative presurgical management. The 20 patients will be randomly divided into two groups of 10 in 1:1 allocation. One group will have embolization of the geniculate artery branches and standard of care while the other will have only the standard care. Following the completion of the 10 participants in each arm, a safety and data review will be undertaken (Visit 4 in the GAE group and Visit 2 of the SOC). The data will be assessed regarding the trends between the groups as they relate to KOOS/WOMAC pain scale, MRI / Xray evaluation of OA, and presence of inflammatory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAE + Standard of Care | Experimental | Device: Geniculate Artery EmbolizationParticipants in this arm will receive geniculate artery embolization and standard of care. |
| Standard of Care | No intervention | –Participants in this arm will receive standard of care only. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between 40 - 70 years of age.
- Unilaterally dominant symptomatic OA (bilateral radiographic OA will not exclude).
- Symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or intra-articular injections of the affected knee in the last 3 months).
- Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
- Willing to comply with the protocol requirements and willing to undergo non- contrast MRI during screening and at 12 months.
Key exclusion criteria (24 listed)
- BMI >35 kg/m2
- Advanced peripheral arterial disease (resting ABI <= 0.9).
- Known significant peripheral arterial disease precluding common femoral catheterization
- Have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
- Diabetics with hemoglobin A1C of >9%
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 |
|---|---|---|
| Geniculate Artery EmbolizationAll patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries. For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee. | Device | GAE + Standard of Care |
Primary outcome
Safety as Assessed by Grade 3-4 Adverse events
Time frame: 12 months
Safety will be reported using the combined number of grade 3 and 4 adverse events that occur in each arm.
8 secondary outcomes
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline, 1 month, 6 months, 12 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline, 1 month, 6 months, 12 months
IL-6 Concentration
Time frame: baseline, 1 month, 12 months
Prostaglandin E2 Concentration
Time frame: baseline, 1 month, 12 months
Matrix Metalloprotinase 1 Concentration
Time frame: baseline, 1 month, 12 months
Vascular Endothelial Growth Factor Concentration
Time frame: baseline, 1 month, 12 months
C-Reactive Protein Concentration
Time frame: baseline, 1 month, 12 months
Erythrocyte Sedimentation Rate
Time frame: baseline, 1 month, 12 months
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 29 May 2026.
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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.
Reza Talaie, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geniculate Artery Embolization in people with Osteo Arthritis Knee and Arthritis, run by University of Minnesota 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 8 inclusion and 24 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 29 May 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?
Safety as Assessed by Grade 3-4 Adverse events (time frame: 12 months). 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 29 May 2026.