Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis

NCT06166628 | Recruiting DMC

• 1 other identifier: 6038931
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Artery embolization; Nerve ablation; Genicular Artery Embolization

Outcome Measures

Primary Outcomes (1)

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

  Overall efficacy of treatment as determined by a clinically significant reduction in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire of 20 points or more. The WOMAC is a questionnaire evaluating knee osteoarthritis with subcategory scores for pain (0-20 points), stiffness (0 - points), physical function (0-8 points), and sum total score (0-96 points) with higher values indicating more severe symptoms.

  3 months

Secondary Outcomes (4)

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

  3 and 6 months

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

  3 and 6 months

• Evaluation of MRI

  3 months

• Evaluation of Synovial Fluid

  3 months

Study Arms (3)

Genicular artery embolization

ACTIVE COMPARATOR

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.

Procedure: Geniculate artery embolization

Genicular nerve phenol nerve ablation

ACTIVE COMPARATOR

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.

Procedure: Genicular nerve phenol nerve ablation

Sham procedure

SHAM COMPARATOR

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.

Procedure: Skin infiltration of 2cc of 0.25% bupivacaine at the knee

Interventions

Geniculate artery embolization PROCEDURE

Femoral arterial access will be obtained under ultrasound guidance. An angiographic catheter will then be advanced to the distal superficial femoral artery. Angiography will be performed to identify the appropriate genicular branches supplying the regions of hyperemia. A microcatheter (1.7-2.4-French) will then be advanced super-selectively into the genicular arteries and 100-300 um EmboSpheres (Merit Medical) will be injected under fluoroscopic guidance. Multiple geniculate arteries may be embolized until neovascularity is no longer seen and pathologic hyperemia is resolved. A repeat lower extremity angiogram will be performed to evaluate for success of embolization and to exclude complication. The catheter and sheath will then be removed, and hemostasis will be achieved using an AngioSeal (Terumo Vascular Interventions) vascular closure device.

Genicular artery embolization

Genicular nerve phenol nerve ablation PROCEDURE

A high frequency ultrasound probe and anatomic landmarks will be used to identify the location of the genicular nerves as well as the nerves to the vastus lateralis, vastus intermedius and vastus medialis. Utilizing an in or out of plane approach as necessary, a 25 g spinal needle will be advanced to the appropriate location after skin anesthesia with 1cc of 1% lidocaine. After negative aspiration, 2 cc of 6% phenol will be injected at each location with an end target of fascial expansion under the relevant fascial plane.

Genicular nerve phenol nerve ablation

Skin infiltration of 2cc of 0.25% bupivacaine at the knee PROCEDURE

A high frequency ultrasound probe and anatomic landmarks will be used to identify the location of the genicular nerves as well as the nerves to the vastus lateralis, vastus intermedius and vastus medialis will be identified. Utilizing an in or out of plane approach as necessary, a 25 g spinal needle will be advanced to the appropriate location after skin anesthesia with 1cc of 1% lidocaine. After negative aspiration, 1.5 cc of sterile saline will then be injected at each location.

Sham procedure

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 40 years
• Able to provide informed consent
• Knee pain due to osteoarthritis for at least 6 months
• Pain refractory to conservative therapies (oral medication, or physical therapy, or activity modification) for at least 3 months with a desire for TKA
• Candidate for TKA at Hotel Dieu Hospital Site
• Able to comply with all treatments and protocol follow-up visits

You may not qualify if:

• Current local infection
• Systemic or joint centered inflammatory disease (ie rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases)
• Current use of systemic immunosuppression therapy
• Known lower extremity vascular disease or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain)
• Irreversible coagulopathy
• Renal dysfunction as defined by GFR (eGFR) of \<30 obtained within the past 60 days
• Contraindication for MR Imaging (such as claustrophobia, metallic fragment or foreign bones, implants or prosthesis)
• IV CT and/or MRI contrast allergy characterized by anaphylaxis or anaphylactoid reactions
• Pregnancy or women of childbearing potential not currently on a medically acceptable method of birth control

Sponsors & Collaborators

• David Clinkard: lead
• Queen's University: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• David Clinkard, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Alexandre Menard, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Steve Mann, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Clinkard, MD

CONTACT

613-549-6666; david.clinkard@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 12, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)