Recruiting

GAE & Nerve Ablation

Sponsor:

David Clinkard

Code:

NCT06166628

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Geniculate artery embolization

Genicular nerve phenol nerve ablation

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

Study Details

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

Study ID

NCT06166628

Start date

Dec 1, 2023

Status verified date

Dec, 2023

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Genicular artery embolization

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.

active comparator: Genicular nerve phenol nerve ablation

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.

sham comparator: Sham procedure

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.

Interventions

Geniculate artery embolization

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 nerve phenol nerve ablation

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.

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

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.

Primary outcome measure

  • Changes in knee pain/functionality post geniculate artery embolization versus nerve ablation vs sham [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

David Clinkard, MD

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

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

David Clinkard, MD

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

More Information

Sponsor

David Clinkard

Last update posted

Dec 28, 2023

Last verified

Dec, 2023

Keywords

  • Artery embolization
  • Nerve ablation
  • Genicular Artery Embolization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Clinkard on 2023-12-28.