12 Participants Needed

Knee Artery Embolization for Osteoarthritis

CO
SB
Overseen BySamuel Bidwell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.12678

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.12479

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.

Research Team

AU

Andre Uflacker, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.
See 2 more

Exclusion Criteria

I have Rheumatoid Arthritis or Gout.
I have bleeding within my joints.
My knee cancer is confirmed.
See 6 more

Timeline

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: GAE and MRI treatment armExperimental Treatment2 Interventions
GAE is geniculate artery embolization.

Find a Clinic Near You

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 profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

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.
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.
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.
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]

References

Genicular Artery Embolization for Treatment of Knee Osteoarthritis: Interim Analysis of a Prospective Pilot Trial Including Effect on Serum Osteoarthritis-Associated Biomarkers. [2023]
Technically Successful Geniculate Artery Embolization Does Not Equate Clinical Success for Treatment of Recurrent Knee Hemarthrosis after Knee Surgery. [2016]
Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. [2023]
[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. [2022]
The Value of Preprocedural MR Imaging in Genicular Artery Embolization for Patients with Osteoarthritic Knee Pain. [2020]
Outcomes after Genicular Artery Embolization Vary According to the Radiographic Severity of Osteoarthritis: Results from a Prospective Single-Center Study. [2023]
Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022]
[Efficacy analysis of selective genicular artery embolization in the treatment of knee pain secondary to osteoarthritis]. [2022]
Genicular Artery Embolization for Refractory Hemarthrosis following Total Knee Arthroplasty: Technique, Safety, Efficacy, and Patient-Reported Outcomes. [2021]
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