Knee OsteoarthritisGAE-KOANCT06940479
Evaluating Changes in Synovial Fluid Before and After GAE for Knee Osteoarthritis
A study testing GAE procedure in people with Knee Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if genicular artery embolization (GAE) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. The main question it aims to answer is: Does the GAE procedure improve knee pain and decrease inflammation? Researchers will compare synovial fluid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- GAE procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to Jul 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Planned to undergo genicular artery embolization to treat knee osteoarthritis.
- Osteoarthritis on knee radiograph (Kellgren-Lawrence score 1-3) within the last 6 months
- Persistent moderate to severe knee pain (visual analog scale [VAS] >3) for at least 6 months
- Pain refractory or intolerant to conservative therapies (e.g. analgesia, exercise, weight-loss, joint injections, physical therapy)
- BMI < 35 kg / m2
- Stated willingness to comply with study procedures and availability for the duration of the study
Who cannot join
- Coagulation disturbances not normalized by medical treatment (INR >1.8 and platelets <50 x 10^9/L)
- Receiving medications for anticoagulation which cannot safely be held for the procedure (e.g ASA for 5 days, Lovenox for 24 hours, Eliquis for 4-6 days depending on creatinine clearance
- Allergy to iodinated contrast agents not responsive to steroid premedication regimen
- Active knee joint infection
- Acute knee injury with surgical indication (MRI evidence of acute fracture or ligamentous injury of the knee)
- Prior total or partial knee replacement in the subject knee
Show all 15Show fewer
- Intra-articular steroid injection within 2 months
- Untreated lower extremity vascular arterial disease
- Untreated venous insufficiency
- Presence of medical condition with life expectancy less than 6 months
- Patients who have undergone previous lower extremity embolization
- Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis
- Patients who are pregnant or intend to become pregnant within 6 months of the procedure
- American Society of Anesthesiologists classification > 3
- Less than 3 mm of synovial fluid in the lateral suprapatellar recess on MRI or US
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Shireen Shikak, BS, 720-848-6767
Leigh Casadaban, MD
About this study
Official title: Genicular Artery Embolization for Knee Osteoarthritis: Evaluation of the Correlation Between Subjective Symptom Response and Objective Measures of Inflammation
The goal of this clinical trial is to learn if genicular artery embolization (GAE) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. The main question it aims to answer is:
- Does the GAE procedure improve knee pain and decrease inflammation?
Researchers will compare synovial fluid samples taken from the knee before and after the procedure.
Participants will:
- Have a contrast enhanced MRI before and after the procedure
- Complete performance-based measures before and after the procedure
- Complete questionnaires before and after the procedure
- Conditions
- Knee Osteoarthritis
- Being tested
- GAE procedure
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAE procedureProcedure or surgery
Genicular artery embolization
| Study group | Role | What they receive |
|---|---|---|
| GAE procedure | Other | Participants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure. Receives: Procedure: GAE procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes in KOOS score and synovial fluid biomarkers
To estimate the correlation between objective changes in synovial fluid biomarkers (IL-6, VEGF and MCP-1) and changes in subjective symptomatic response (KOOS) 3 months after treatment of knee osteoarthritis with GAE.
KOOS is a validated knee osteoarthritis scoring system that involves five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions).
Trials demonstrate maximum symptomatic response to GAE at 3 months, and sustained improvement for at least 1-2 years. Improvement in KOOS reflects symptomatic response to treatment. This will determine whether changes in the local inflammatory environment in the knee synovium correlate with symptomatic response to GAE. This would also help elucidate whether the mechanism of action of GAE is likely attributable to inflammation.
Measured: 3 months after GAE procedure
Secondary outcomes (6)
Measure changes in synovial enhancement with contrast-enhanced MRI according to WORMS synovitis scores
The WORMS scoring system is a semi-quantitative assessment of 14 features found on knee MRI. The WORMS synovitis subscale is scored based on the distension of the joint capsule and is graded from 0 to 3 in terms of the estimated maximal distention of the synovial cavity with 0=normal, grade 1=<33% of maximum potential distention grade 2=33%-66% of maximum potential distention and grade 3=>66% of maximum potential distention
WORMS will be used to determine changes in synovial fluid biomarkers pre-treatment and 3 months after treatment of knee osteoarthritis with GAE.
Measured: 3 months after GAE procedure
Measure changes in synovial enhancement with contrast-enhanced MRI according to MOST grading system
The MRI will also be evaluated using the Multicenter Osteoarthritis Study grading system for synovitis.
The Multicenter Osteoarthritis Study (MOST) grading system for knee synovitis is an alternative to the WORMS synovitis score and incorporates a larger range of grading. The higher the score, the worse the synovial inflammation. The scoring ranges from 0-13, with 0-4 for normal or equivocal synovitis, 5-8 for mild synovitis, 9-12 for moderate synovitis, and 13 or greater for severe synovitis.
Measured: 3 months after GAE procedure
Measure changes in VAS scores
Patients will be given VAS questionnaires to give subjective responses to changes in pain levels and its effect on activities of daily living.
VAS is calculated by scoring pain level between 0-100. This is asked verbally "How would you rate your pain in the affected knee?"
These questionnaires will be given at time points: screening, 1 month after GAE, 3 months, 6 months and 12 months.
Measured: 12 months after procedure
Measure changes in KOOS scores
The Knee Injury and Osteoarthritis Outcome Score involves five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions).
Patients will be given KOOS questionnaires to give subjective responses to changes in pain levels and its effect on activities of daily living.
These questionnaires will be given at time points: screening, 1 month after GAE, 3 months, 6 months and 12 months.
Measured: 12 months after procedure
Estimate correlation between objective measures to symptomatic response
To estimate the correlation between objective measures of knee pain or inflammation (performance-based measures, contrast-enhanced MRI synovitis scores) to symptomatic response (KOOS) 3 months after treatment of knee osteoarthritis with GAE. This may provide additional assurance in the form of objective measures of response in a disease that is known to have a strong placebo effect.
Measured: 3 months after GAE procedure
Estimate correlation between changes in a larger set of synovial fluid biomarkers and changes in subjective scores
To estimate the correlation between changes in a larger set of synovial fluid biomarkers (54markers across inflammation, chemotaxis, angiogenesis, and immune system regulation pathways) and changes in subjective scores (KOOS) 3 months after treatment. This will further develop the interrogation of which microenvironment pathways in the knee synovium correlate with symptomatic response to GAE.
Measured: 3 months after GAE procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start16 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Casadaban, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940479
- Sponsor's protocol ID
- 24-1048
- Acronym
- GAE-KOA
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genicular Artery Embolization for Knee Osteoarthritis: Evaluation of the Correlation Between Subjective Symptom Response and Objective Measures of Inflammation
- ClinicalTrials.gov ID
- NCT06940479
- Acronym / sponsor ID
- GAE-KOA / 24-1048
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Apr 2025 (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 goal of this clinical trial is to learn if genicular artery embolization (GAE) can improve knee pain and decrease inflammation in adults with knee osteoarthritis. The main question it aims to answer is:
- Does the GAE procedure improve knee pain and decrease inflammation?
Researchers will compare synovial fluid samples taken from the knee before and after the procedure.
Participants will:
- Have a contrast enhanced MRI before and after the procedure
- Complete performance-based measures before and after the procedure
- Complete questionnaires before and after the procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAE procedure | Other | Procedure: GAE procedureParticipants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Planned to undergo genicular artery embolization to treat knee osteoarthritis.
- Osteoarthritis on knee radiograph (Kellgren-Lawrence score 1-3) within the last 6 months
- Persistent moderate to severe knee pain (visual analog scale [VAS] >3) for at least 6 months
- Pain refractory or intolerant to conservative therapies (e.g. analgesia, exercise, weight-loss, joint injections, physical therapy)
Key exclusion criteria (15 listed)
- Coagulation disturbances not normalized by medical treatment (INR >1.8 and platelets <50 x 10^9/L)
- Receiving medications for anticoagulation which cannot safely be held for the procedure (e.g ASA for 5 days, Lovenox for 24 hours, Eliquis for 4-6 days depending on creatinine clearance
- Allergy to iodinated contrast agents not responsive to steroid premedication regimen
- Active knee joint infection
- Acute knee injury with surgical indication (MRI evidence of acute fracture or ligamentous injury of the 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 |
|---|---|---|
| GAE procedureGenicular artery embolization | Procedure or surgery | GAE procedure |
Primary outcome
Measure changes in KOOS score and synovial fluid biomarkers
Time frame: 3 months after GAE procedure
To estimate the correlation between objective changes in synovial fluid biomarkers (IL-6, VEGF and MCP-1) and changes in subjective symptomatic response (KOOS) 3 months after treatment of knee osteoarthritis with GAE. KOOS is a validated knee osteoarthritis scoring system that involves five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions). Trials demonstrate maximum symptomatic response to GAE at 3 months, and sustained improvement for at least 1-2 years. Improvement in KOOS reflects symptomatic response to treatment. This will determine whether changes in the local inflammatory environment in the knee synovium correlate with symptomatic response to GAE. This would also help elucidate whether the mechanism of action of GAE is likely attributable to inflammation.
6 secondary outcomes
Measure changes in synovial enhancement with contrast-enhanced MRI according to WORMS synovitis scores
Time frame: 3 months after GAE procedure
Measure changes in synovial enhancement with contrast-enhanced MRI according to MOST grading system
Time frame: 3 months after GAE procedure
Measure changes in VAS scores
Time frame: 12 months after procedure
Measure changes in KOOS scores
Time frame: 12 months after procedure
Estimate correlation between objective measures to symptomatic response
Time frame: 3 months after GAE procedure
Estimate correlation between changes in a larger set of synovial fluid biomarkers and changes in subjective scores
Time frame: 3 months after GAE procedure
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Leigh Casadaban, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAE procedure in people with Knee Osteoarthritis, run by University of Colorado, Denver 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 7 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
Contact Shireen Shikak, BS (720.848.6618, shireen.shikak@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure changes in KOOS score and synovial fluid biomarkers (time frame: 3 months after GAE procedure). 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 24 Mar 2026.