Artery Embolization vs Nerve Ablation for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Steve Mann, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: David Clinkard

Must not be taking: Immunosuppressants

Disqualifiers: Infection, Autoimmune diseases, Vascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The genicular artery embolization vs nerve ablation intervention (GENI) knee OA study is a three-arm randomized controlled trial to evaluate symptoms of knee osteoarthritis (OA) in patients after receiving one of three interventions: sham procedure, geniculate artery embolization (GAE) or genicular nerve phenol nerve ablation (PNA). The main question\[s\] the study aims to answer are: * Does GAE or genicular nerve PNA result in OA symptom alleviation compared to sham procedure? * Are there molecular or imaging biomarkers that aid in predicting treatment response for GAE or genicular nerve PNA? Subjects (N=150) patients with knee OA, resistant to non-surgical treatment for at least 3 months will be randomized 1:1:1 to either after GAE, genicular nerve PNA or sham procedure. Clinical outcomes will be measured using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and 11-point numerical rating scale (NRS) for pain completed at baseline, 1 month, 3 months, and 6 months and then every 6 months for either two years or until the time of total knee arthroplasty (TKA) surgery.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves patients with knee osteoarthritis resistant to non-surgical treatment, it might be possible to continue some medications. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of this treatment for knee osteoarthritis?

Research shows that genicular nerve ablation and genicular artery embolization are promising treatments for knee osteoarthritis pain, especially in patients who do not respond to other treatments. Studies indicate that these methods can help reduce pain by targeting specific nerves or blood vessels in the knee. ^{1 2 3 4 5}

Is genicular artery embolization or nerve ablation safe for humans?

Genicular artery embolization (GAE) is generally safe for treating knee pain from osteoarthritis, with adverse events being uncommon when the procedure is done carefully. The safety of chemical ablation of the genicular nerve with phenol has not been thoroughly examined, but it is being studied for its potential use in pain relief for knee osteoarthritis. ^{1 3 6 7 8}

How is the treatment for knee osteoarthritis using artery embolization and nerve ablation different from other treatments?

This treatment is unique because it combines genicular artery embolization (GAE), which blocks blood flow to reduce inflammation and pain, with genicular nerve ablation, which targets and disrupts pain signals from the nerves around the knee. Unlike traditional treatments that may focus on medication or surgery, this approach directly addresses both blood supply and nerve pathways to provide potentially long-lasting pain relief. ^{1 3 7 9 10}

Eligibility Criteria

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.

Inclusion Criteria

I am over 40 years old.

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

Able to provide informed consent

Exclusion Criteria

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

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

I am currently on medication that weakens my immune system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment including WOMAC and NRS scores, MRI, and synovial fluid analysis

1 week

1 visit (in-person)

Treatment

Participants receive either genicular artery embolization, genicular nerve phenol nerve ablation, or a sham procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with WOMAC and NRS scores, MRI, and synovial fluid analysis

24 months

Phone follow-ups every 6 months, in-person visits at 3 months

Treatment Details

Interventions

• Genicular nerve phenol nerve ablation (Procedure)
• Geniculate artery embolization (Procedure)

Trial Overview 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.

Participant Groups

Group I: Genicular artery embolization Active Control 1 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 ablation Active Control 1 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 procedure Placebo Group 1 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.

Genicular nerve phenol nerve ablation is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Genicular nerve ablation for:

• Investigational for knee osteoarthritis pain relief

🇪🇺 Approved in European Union as Genicular nerve ablation for:

• Not approved for routine use; considered investigational for knee osteoarthritis pain relief

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Kingston Health Sciences Centre Kingston, Canada

Who Is Running the Clinical Trial?

David Clinkard Lead Sponsor

David Clinkard Lead Sponsor

Queen's University Collaborator

Kingston Health Sciences Centre Collaborator

References

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

Three Needles Approach-A New Technique of Genicular Nerves Radiofrequency Ablation for Pain Relief in Advanced Chronic Knee Osteoarthritis: A Randomized Trial. [2021] Ablation of the genicular nerves (GN) has emerged as a useful alternative therapeutic modality in chronic knee osteoarthritis (OA) specially for high-risk patients. However, in some cases due to the presence of other articular branches or anatomical variability, it may have a poor impact in relieving pain. Ablation of other or additional articular branches might have different outcomes.

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

Genicular Artery Embolization as a Treatment for Osteoarthritis Related Knee Pain: A Systematic Review and Meta-analysis. [2023] Genicular artery embolization (GAE) is a minimally invasive therapy for symptomatic osteoarthritis (OA) in patients with knee pain refractory to conservative management. The purpose of this study was to evaluate evidence on the effectiveness of GAE for OA related knee pain as part of a systematic review and meta-analysis.

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. 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.

5. 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.

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of genicular nerve phenol neurolysis and radiofrequency ablation for pain management in patients with knee osteoarthritis. [2023] : Genicular nerve neurolysis with phenol and radiofrequency ablation (RFA) are two interventional techniques for treating chronic refractory knee osteoarthritis (KOA) pain. This study aimed to compare the efficacy and adverse effects of both techniques.

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

Genicular Artery Embolization Technique. [2023] Genicular artery embolization (GAE) is a safe and effective treatment for knee pain related to osteoarthritis, however there are several aspects of the procedure technique which may be unique. Familiarity with procedural steps, arterial anatomy, embolic endpoints, technical challenges, and potential complications is imperative for good clinical practice and outcomes. The success of GAE depends on correctly interpreting angiographic findings and variable anatomy, navigating small and acutely angled arteries, recognizing collateral supply, and avoiding non-target embolization. The procedure can potentially be performed for a wide range of patients with knee osteoarthritis. When effective, pain relief can be durable for many years. When done meticulously, adverse events from GAE are uncommon.

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

Chemical Ablation of Genicular Nerve with Phenol for Pain Relief in Patients with Knee Osteoarthritis: A Prospective Study. [2021] Radiofrequency ablation of the genicular nerve is performed for knee osteoarthritis (KOA) when conservative treatment is not effective. Chemical ablation may be an alternative, but its effectiveness and safety have not been examined. The objective of this prospective open-label cohort study is to evaluate the effectiveness and safety of ultrasound-guided chemical neurolysis for genicular nerves with phenol to treat patients with chronic pain from KOA.

9. 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.

10. 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] To characterize the safety, efficacy, and potential role of genicular artery embolization (GAE) as a disease-modifying treatment for symptomatic knee osteoarthritis (OA).