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

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 1, 2026

Study Completion Date

December 31, 2026

Conditions
Knee Osteoarthritis
Interventions
PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

K7L 2V7

RECRUITING

Kingston Health Sciences Centre, Kingston

All Listed Sponsors
collaborator

Queen's University

OTHER

lead

David Clinkard

OTHER