20 Participants Needed

Geniculate Artery Embolization for Osteoarthritis

RT
AC
PT
CD
AW
MF
Overseen ByMary Farnsworth
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
Must be taking: Anti-inflammatories
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation medications, they must be safely held for the procedure and for 7 days afterward.

Is Genicular Artery Embolization (GAE) safe for humans?

Research on Genicular Artery Embolization (GAE) for knee osteoarthritis suggests it is a minimally-invasive treatment with studies evaluating its safety. These studies indicate that GAE is generally considered safe for treating knee osteoarthritis, though it is important to consult with a healthcare provider for personalized advice.12345

How is Geniculate Artery Embolization different from other treatments for knee osteoarthritis?

Geniculate Artery Embolization (GAE) is a novel, minimally-invasive treatment specifically targeting the blood vessels in the knee to reduce pain from osteoarthritis, unlike traditional treatments that often involve medication or surgery.24567

What is the purpose of this trial?

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.

Research Team

RT

Reza Talaie, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for people with mild to moderate knee osteoarthritis who haven't improved after at least 3 months of treatments like anti-inflammatory drugs or physical therapy. They should be under 250 pounds, not planning on knee replacement surgery soon, and able to get an MRI before and after the procedure. People can't join if they're over 250 pounds, have certain heart or blood conditions, severe allergies to iodine, are pregnant, or have had certain knee surgeries.

Inclusion Criteria

Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
Patients with WOMAC Score >=6 in at least 2 categories
Patients who are 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 0-1 intra-articular injections of the affected knee)
See 5 more

Exclusion Criteria

Patients with a platelet count <50x109/L
Patients with a weight >250 pounds
Patients with advanced peripheral arterial disease (resting ABI <= 0.9)
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive geniculate artery embolization and standard of care or standard of care only

12 months
4 visits (in-person) for GAE group, 2 visits (in-person) for SOC group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

  • Geniculate Artery Embolization
Trial Overview The study tests geniculate artery embolization (a minimally invasive procedure that blocks abnormal blood vessels) plus standard care against standard care alone in managing knee osteoarthritis symptoms. It aims to see if this treatment can control symptoms better and slow down disease progression.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: GAE + Standard of CareExperimental Treatment1 Intervention
Participants in this arm will receive geniculate artery embolization and standard of care.
Group II: Standard of CareActive Control1 Intervention
Participants in this arm will receive standard of care only.

Geniculate Artery Embolization is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Genicular Artery Embolization for:
  • Symptomatic management of knee osteoarthritis
🇪🇺
Approved in European Union as Genicular Artery Embolization for:
  • Treatment of chronic mild to moderate knee pain secondary to osteoarthritis

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Genicular artery embolization (GAE) is a promising treatment for symptomatic knee osteoarthritis, showing a significant reduction in pain and symptoms over 12 months, with 68% of patients experiencing at least a 50% reduction in pain scores.
The procedure was found to be technically successful in all 40 participants, with a generally acceptable safety profile, although some patients experienced mild and transient side effects, such as skin discoloration and knee pain.
Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis.Padia, SA., Genshaft, S., Blumstein, G., et al.[2022]
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]
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.
Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis.Bagla, S., Piechowiak, R., Sajan, A., et al.[2022]

References

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. [2022]
Common Design, Data Elements and Core Outcome Measures Reported on Clinical Trials of Genicular Artery Embolization for Knee Osteoarthritis: An Interactive Systematic Review. [2023]
Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022]
The short-to-midterm outcomes of geniculate artery embolization for mild-to-moderate osteoarthritis of the knee: a systematic review. [2023]
Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography. [2023]
Cadaveric and Angiographic Anatomical Considerations in the Genicular Arterial System: Implications for Genicular Artery Embolisation in Patients with Knee Osteoarthritis. [2021]
[Embolization of genicular arteries in patients with knee osteoarthritis as an alternative for refractory pain treatment: A systematic review]. [2022]
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