Geniculate Artery Embolization for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Reza Talaie, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Minnesota

Must be taking: Anti-inflammatories

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Diabetes, Chronic pain, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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.

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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.

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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)

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)

Trial 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

Participant Groups

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.

Group I: GAE + Standard of Care Experimental Treatment 1 Intervention

Participants in this arm will receive geniculate artery embolization and standard of care.

Group II: Standard of Care Active Control 1 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

Research Locations Nearby Select from list below to view details:

University of Minnesota Minneapolis, MN

Who Is Running the Clinical Trial?

University of Minnesota Lead Sponsor

References

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

Genicular Artery Embolization for the Treatment of Symptomatic Knee Osteoarthritis. [2022] Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA.

2. 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] Genicular artery embolization (GAE) is an emerging, potentially effective treatment option in patients with knee osteoarthritis (OA). This study aimed to describe the current state of common design data elements (CDDEs) and core outcome measures (COMs) in recent trials of GAE for knee OA.

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

Multicenter Randomized Sham Controlled Study of Genicular Artery Embolization for Knee Pain Secondary to Osteoarthritis. [2022] To assess the safety and efficacy of genicular artery embolization (GAE) compared with a sham procedure in the treatment of knee pain secondary to mild to moderate osteoarthritis (OA).

4. India pubmed.ncbi.nlm.nih.gov

The short-to-midterm outcomes of geniculate artery embolization for mild-to-moderate osteoarthritis of the knee: a systematic review. [2023] Geniculate Artery Embolization (GAE) is a novel, minimally-invasive treatment for mild to moderate Osteoarthritis (OA) associated with musculoskeletal pain.

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

Classification of Genicular Artery Anatomic Variants Using Intraoperative Cone-Beam Computed Tomography. [2023] Genicular artery embolization (GAE) is a new treatment option for symptomatic knee osteoarthritis. Genicular arterial anatomy is complex with limited published reports. This study describes the genicular artery anatomy utilizing intraprocedural cone-beam computed tomography (CBCT) during GAE.

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

Cadaveric and Angiographic Anatomical Considerations in the Genicular Arterial System: Implications for Genicular Artery Embolisation in Patients with Knee Osteoarthritis. [2021] Genicular artery embolisation (GAE) is a novel treatment for patients with knee osteoarthritis (OA). Cadaveric dissection was undertaken to provide a complete description of the relevant arterial anatomy in order to perform safe and effective GAE.

7. 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] Genicular artery embolization emerges as an innovative technique described for the treatment of refractory pain in patients with knee osteoarthritis. This review summarizes the available data on the efficacy of genicular artery embolization in patients with knee osteoarthritis (OA) and refractory pain as an alternative treatment or associated with pharmacological treatment.