GAE Procedure for Osteoarthritis

(GAE-KOA Trial)

Overseen By Tricia Luna, MS, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Anticoagulants

Disqualifiers: Coagulation disturbances, Knee infection, Knee replacement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether genicular artery embolization (GAE) can reduce knee pain and inflammation in people with knee osteoarthritis. The researchers aim to determine if this procedure can significantly improve symptoms that have not responded to usual treatments like pain medication or physical therapy. Suitable candidates for this trial are adults who have experienced moderate to severe knee pain for at least six months without relief from other treatments. Participants will undergo MRIs, physical tests, and complete surveys to assess the procedure's effectiveness. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could lead to new treatment options for knee osteoarthritis.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain blood-thinning medications (like aspirin, Lovenox, or Eliquis) for a few days before the procedure. If you're on these medications, you'll need to pause them for a specific time to participate safely.

What prior data suggests that the GAE procedure is safe for osteoarthritis?

Research has shown that genicular artery embolization (GAE) is generally a safe procedure for treating knee osteoarthritis. Studies indicate it successfully reduces symptoms for many patients. Some side effects, such as mild pain or swelling in the treated area, have been reported. Most evidence suggests these side effects are manageable and do not outweigh the benefits. Overall, GAE is considered safe and well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for osteoarthritis, which often focus on pain relief through medications like NSAIDs or corticosteroid injections, the Genicular Artery Embolization (GAE) procedure targets the blood vessels in the knee. Researchers are excited about GAE because it aims to reduce inflammation and pain by blocking specific arteries that supply blood to the inflamed areas. This approach could potentially offer a less invasive alternative to surgery, with the added benefit of directly addressing the source of pain and inflammation, rather than just alleviating symptoms.

What evidence suggests that the GAE procedure is effective for knee osteoarthritis?

Research has shown that genicular artery embolization (GAE), which participants in this trial will undergo, can reduce knee pain and swelling in individuals with knee osteoarthritis. Studies have found that 78–92% of patients experienced significant improvement, with at least a 50% reduction in pain within a year. One study showed a 60-80% decrease in pain over six to 24 months. These findings suggest that GAE can provide lasting relief for those with moderate-to-severe knee osteoarthritis. Additionally, current evidence indicates that this procedure is generally safe. ^{2 6 7 8 9}

Who Is on the Research Team?

Leigh Casadaban, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults with knee osteoarthritis who've had persistent moderate to severe knee pain despite trying conservative treatments. They should have a Kellgren-Lawrence score of 1-3, indicating the severity of their arthritis, and be planning to undergo genicular artery embolization (GAE). Participants must also have a BMI under 35 kg/m2 and commit to the study's duration.

Inclusion Criteria

My BMI is under 35.

I am scheduled for a procedure to treat knee arthritis.

My knee X-ray shows mild to moderate osteoarthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo the GAE procedure, with synovial fluid sampling, performance-based measures, and contrast-enhanced MRI before and after the procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in KOOS scores, synovial fluid biomarkers, and synovial enhancement with MRI at multiple time points

12 months

Visits at 1 month, 3 months, 6 months, and 12 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Genicular Artery Embolization

Trial Overview The trial is testing if GAE can reduce knee pain and inflammation in osteoarthritis patients. It involves comparing synovial fluid from the knee before and after GAE using MRI scans, performance measures, and questionnaires to assess changes in pain levels and joint function.

How Is the Trial Designed?

Group I: GAE procedure Experimental Treatment 1 Intervention

Participants undergoing the GAE procedure will have synovial fluid sampling, performance-based measures and contrast-enhanced MRI before and after the procedure.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9971280/

Genicular artery embolization for treatment of knee ... Limited evidence suggests that GAE is a safe procedure that confers improvement in knee OA symptoms at established MCID thresholds.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633225004398

Meta-Analysis of Genicular Artery Embolization in Knee ... About 78–92% of patients achieved clinically meaningful improvement (≥50% pain reduction or ≥10–15 point change) by 12 months. However, sham-controlled RCTs ...

3. jvir.org jvir.org/article/S1051-0443(24)00581-5/fulltext

Genicular Artery Embolization for Treatment of ... GAE is effective in achieving sustained symptom relief related to moderate-to-severe knee OA for up to 24 months with an acceptable safety ...

4. aaos.org aaos.org/aaosnow/2025/aug-sept/clinical/clinical01/

Data review presents geniculate artery embolization as an ... Several uncontrolled prospective studies have shown 60-80% pain reduction on the visual analog scale at six and 24 months after GAE, suggesting ...

5. link.springer.com link.springer.com/article/10.1007/s00330-025-11702-1

Early intervention in knee osteoarthritis with genicular ... Several trials have demonstrated GAE to be safe and potentially effective in the treatment of symptomatic knee OA. However, there is a paucity ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40219609

Safety and Efficacy of Genicular Artery Embolization for ... Most studies reported a 100% technical success rates, except one study reporting a rate of 84.2%. Clinical success rates, defined variably ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1051044324005815

Clinical Study Genicular Artery Embolization for Treatment ... Conclusions. GAE is effective in achieving sustained symptom relief related to moderate-to-severe knee OA for up to 24 months with an acceptable safety profile.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10723963/

Safety and Efficacy of Genicular Artery Embolization for the ... Technical success in 100% and clinical improvement among 80% of the participants at 3 months follow period proves the safety and efficacy of ...

9. link.springer.com link.springer.com/article/10.1007/s00270-025-04227-z

Safety of Knee Arthroplasty Following Genicular Artery ... Early intervention in knee osteoarthritis with genicular artery embolization is associated with improved clinical outcomes. Article Open ...