Knee Artery Embolization for Osteoarthritis

Overseen By Samuel Bidwell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Renal impairment, Severe atherosclerosis, Rheumatoid arthritis, Gout, others

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

Compensation: Varies

Number of Visits: 6

Duration: 1 day

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that participants should have been on non-surgical therapy like joint injections, oral NSAIDs, or opioid analgesia for at least one month before joining.

Is knee artery embolization safe for treating osteoarthritis?

Research on genicular artery embolization (GAE) for knee osteoarthritis shows it is generally safe, with most patients experiencing only minor side effects like temporary knee stiffness or skin bruising. No major procedure-related adverse events were reported in the studies. ^{1 2 3 4 5}

How is the treatment geniculate artery embolization different from other treatments for knee osteoarthritis?

Geniculate artery embolization (GAE) is a unique treatment for knee osteoarthritis that involves blocking specific blood vessels in the knee to reduce pain and inflammation, unlike traditional treatments that often rely on medications or surgery. This minimally invasive procedure targets the blood supply to the inflamed areas, potentially offering relief for patients with refractory pain who do not respond well to other therapies. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Knee Artery Embolization for Osteoarthritis?

Research suggests that genicular artery embolization (a procedure that blocks blood flow to certain knee arteries) may help reduce pain in people with knee osteoarthritis, especially when other treatments haven't worked. Some studies indicate it could be a promising option for managing symptoms. ^{3 5 6 8 9}

Who Is on the Research Team?

Andre Uflacker, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 25-90 with knee osteoarthritis, who've tried non-surgical pain treatments like injections or NSAIDs. They must be able to consent and have no MRI contraindications, severe kidney issues, malignancy in the knee, rheumatoid arthritis/gout, recent septic arthritis, or past major knee surgery.

Inclusion Criteria

I have knee pain due to arthritis, confirmed by an X-ray.

I can safely undergo MRI scans with contrast.

I have tried non-surgical treatments like injections or painkillers for my knee pain for over a month.

Exclusion Criteria

I have Rheumatoid Arthritis or Gout.

I have bleeding within my joints.

My knee cancer is confirmed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo geniculate artery embolization of the symptomatic knee

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 6, and 12 months post-embolization

12 months

3 visits (in-person)

MRI Evaluation

Participants obtain a knee MRI to evaluate the effect of embolization, with a second MRI at 6 months

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• dynamic contrast enhanced MRI
• geniculate artery embolization

Trial Overview The study tests if geniculate artery embolization reduces pain from knee osteoarthritis and improves quality of life. It involves initial/follow-up clinic visits, two MRIs (one before and one six months after treatment), and participants tracking their pain levels.

How Is the Trial Designed?

Group I: GAE and MRI treatment arm Experimental Treatment 2 Interventions

GAE is geniculate artery embolization.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

Genicular artery embolization (GAE) is a safe and effective treatment for symptomatic knee osteoarthritis, with a 100% technical success rate and no major adverse events reported in a study of 16 patients.

At the 12-month follow-up, 83% of patients achieved a clinically meaningful reduction in pain, and there was a significant decrease in nerve growth factor levels, which may help explain the pain relief and potential slowing of cartilage degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers. Taslakian, B., Swilling, D., Attur, M., et al.[2023]

Geniculate artery embolization is a safe and effective minimally invasive treatment for spontaneous knee hemarthrosis after surgery, achieving 100% technical success in 14 procedures performed on 10 patients.

While the procedure resolved hemarthrosis in 60% of patients, those with serious comorbidities had higher rates of recurrence and required repeat embolization, indicating that patient health status may impact clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technically Successful Geniculate Artery Embolization Does Not Equate Clinical Success for Treatment of Recurrent Knee Hemarthrosis after Knee Surgery. Guevara, CJ., Lee, KA., Barrack, R., et al.[2016]

Genicular artery embolization (GAE) shows promise as a treatment for knee osteoarthritis, with pain being the most commonly reported outcome in 95.8% of the 24 studies reviewed.

However, the studies exhibit significant variability in design and methodology, which limits the ability to draw strong conclusions about the efficacy and safety of GAE, highlighting the need for more standardized research protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. Bolsegui, ML., Ghozy, S., Kobeissi, H., et al.[2023]

Genicular artery embolization has been shown to be a potentially effective treatment for chronic pain in patients with knee osteoarthritis, based on a review of 13 studies involving 914 patients.

The procedure is associated with only minor complications, suggesting it is a safe alternative for patients who do not respond to conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. Guevara-Noriega, KA., Chavez-Abiega, R., Castro-Rios, JG.[2022]

In a study of 28 knees from 18 patients, preprocedural MR imaging was found to be valuable in predicting the effectiveness of genicular artery embolization (GAE) for treating knee pain, with specific findings like bone marrow lesions (BMLs) and meniscal injuries correlating with treatment outcomes.

Patients with lower Kellgren-Lawrence (KL) grades and smaller BMLs were more likely to respond positively to GAE, suggesting that these imaging markers can help identify candidates who may benefit from the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of Preprocedural MR Imaging in Genicular Artery Embolization for Patients with Osteoarthritic Knee Pain. Choi, JW., Ro, DH., Chae, HD., et al.[2020]

In a study of 33 participants, those with mild knee osteoarthritis (81.8%) showed significantly better improvement in pain and function after genicular artery embolization compared to those with moderate to severe osteoarthritis (36.4%).

No serious adverse events were reported, indicating that genicular artery embolization is a safe procedure, even in patients with varying degrees of osteoarthritis severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes after Genicular Artery Embolization Vary According to the Radiographic Severity of Osteoarthritis: Results from a Prospective Single-Center Study. Gill, SD., Hely, R., Hely, A., et al.[2023]

In a study of 21 patients with mild to moderate knee osteoarthritis, genicular artery embolization (GAE) significantly reduced pain and disability compared to a sham procedure, with notable improvements observed at 1 month.

Only minor adverse events were reported, indicating that GAE is a safe intervention for treating knee pain associated with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. Bagla, S., Piechowiak, R., Sajan, A., et al.[2022]

Selective genicular artery embolization (GAE) showed a high clinical improvement rate of 95.6% at 1 month and maintained significant pain relief at 6 months for patients with knee pain due to osteoarthritis, based on assessments using the Visual Analogue Scale (VAS) and WOMAC scores.

The procedure had a low incidence of adverse reactions, with only minor issues reported, such as skin ecchymosis and temporary knee stiffness, indicating that GAE is a safe and effective treatment option for patients who do not respond to conservative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. Sun, CH., Gao, ZL., Lin, K., et al.[2022]

Genicular artery embolization is a safe and effective treatment for recurrent hemarthrosis after total knee arthroplasty, achieving clinical success rates of 56%, 79%, and 85% after the first, second, and third treatments, respectively, across 117 procedures.

The procedure had a high technical success rate with minimal serious complications (12.8%), primarily transient cutaneous ischemia, and 83% of patients reported satisfaction with the results, indicating its potential as a reliable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for Refractory Hemarthrosis following Total Knee Arthroplasty: Technique, Safety, Efficacy, and Patient-Reported Outcomes. Cornman-Homonoff, J., Kishore, SA., Waddell, BS., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Technically Successful Geniculate Artery Embolization Does Not Equate Clinical Success for Treatment of Recurrent Knee Hemarthrosis after Knee Surgery. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Value of Preprocedural MR Imaging in Genicular Artery Embolization for Patients with Osteoarthritic Knee Pain. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes after Genicular Artery Embolization Vary According to the Radiographic Severity of Osteoarthritis: Results from a Prospective Single-Center Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Genicular Artery Embolization for Refractory Hemarthrosis following Total Knee Arthroplasty: Technique, Safety, Efficacy, and Patient-Reported Outcomes. [2021]