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Procedure

Artery Embolization vs Nerve Ablation for Knee Osteoarthritis

N/A

Recruiting

Led By David Clinkard, MD

Research Sponsored by David Clinkard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 40 years

Knee pain due to osteoarthritis for at least 6 months

Must not have

Renal dysfunction as defined by GFR (eGFR) of <30 obtained within the past 60 days

Systemic or joint centered inflammatory disease (e.g. rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 6 months

Summary

This trial tests if procedures to reduce knee OA symptoms work better than a sham procedure. 150 patients with knee OA to be randomized 1:1:1 to GAE, PNA or sham procedure. Clinical outcomes measured at baseline, 1, 3, 6 months and every 6 months for 2 years.

Who is the study for?

This trial is for people over 40 with knee pain from osteoarthritis, who haven't improved after at least 3 months of non-surgical treatments and are considering knee replacement surgery. They must be able to follow the study plan and attend all check-ups.

What is being tested?

The GENI study tests if genicular artery embolization (GAE) or genicular nerve phenol ablation (PNA) can relieve osteoarthritis symptoms better than a sham procedure. Patients will be randomly assigned to one of these three options.

What are the potential side effects?

Possible side effects include discomfort at the injection site, allergic reactions to local anesthetics or contrast agents used in imaging, and potential risks associated with nerve ablation or artery embolization procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 40 years old.

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I have had knee pain from arthritis for over 6 months.

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My knee pain hasn't improved with medication or physical therapy for 3 months, and I want a knee replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is low, with a GFR less than 30 in the last 60 days.

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I have a condition like rheumatoid arthritis, Lupus, or MS.

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I am currently on medication that weakens my immune system.

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I have vascular disease in my legs causing pain or discomfort.

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I have a permanent blood clotting disorder.

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I have an infection at a specific body site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in knee pain/functionality post geniculate artery embolization versus nerve ablation vs sham

Secondary study objectives

Assessment of desire for total knee arthroplasty post geniculate artery embolization versus nerve ablation vs sham

Changes in numerical rating scale pain scores post geniculate artery embolization versus nerve ablation vs sham

Evaluation of MRI

+1 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Genicular artery embolizationActive Control1 Intervention

Genicular artery embolization will be performed by board certified Interventional Radiologists in the interventional radiology angiography suite at Kingston General Hospital. Patients will be blinded to which procedure they have been randomized too, careful language will be used by the clinical and research team throughout the procedure to not compromise the blinding. Patients will be positioned supine on the procedure table. The affected knee will be prepped and draped using standard sterile technique and 1-2cc of 1% lidocaine will be administered to the area for local anesthetic. A drape will be placed such that the patient is unable to see the affected knee during the procedure. Geniculate artery embolization will be performed via an intraarterial access and use of embolization microspheres injected into the hypervascular arteries feeding the knee joint.

Group II: Genicular nerve phenol nerve ablationActive Control1 Intervention

Genicular nerve phenol nerve ablation All procedures will be performed by a fellowship trained interventional pain physician in a fluoroscopy suite in Hotel Dieu Hospital using sterile precautions. Patients will be blinded to which procedure they have been randomized too, careful language will be used by the clinical and research team throughout the procedure to not compromise the blinding. IV access and saline lock obtained per our usual clinic protocol. Patients will be positioned supine on the procedure table. The affected knee will be prepped and draped using standard sterile technique and 1-2cc of 1% lidocaine will be administered to the area for local anesthetic. Phenol nerve ablation will be performed via ultrasound guidance.

Group III: Sham procedurePlacebo Group1 Intervention

The sham procedure will be performed by a fellowship trained interventional pain physician in a fluoroscopy suite in Hotel Dieu Hospital using sterile precautions. Patients will be blinded to which procedure they have been randomized too, careful language will be used by the clinical and research team throughout the procedure to not compromise the blinding. IV access and saline lock obtained per our usual clinic protocol. The patient will be placed supine, and the appropriate knee prepped and draped using appropriate sterile technique . A drape will be placed such that the patient is unable to see the affected knee during the procedure.

0 / 9Eligibility criteria met