Geniculate Nerve Ablation vs Geniculate Artery Embolization vs Sham for Knee Osteoarthritic Pain

NCT04662840 | Withdrawn Phase 4

• 1 other identifier: MP-37-2021-6838
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This is a three-arm prospective double-blinded randomized comparative trial aimed at comparing results regarding knee pain improvement in patients with osteoarthritis (OA) of the knee awaiting total knee arthroplasty (TKA) by either a sham procedure, a geniculate artery embolization procedure or a geniculate nerve ablation procedure. Experienced interventional radiologists and anesthetists at the McGill University Health Centre (MUHC) and study affiliated centers will carry out all interventions. 72 consecutive subjects meeting the eligibility criteria, considered for knee replacement in the future. Patients will be randomized to receive either the embolization procedure, the nerve ablation procedure or a sham procedure. Monitoring of pain will be recorded using visual analog scales, pain medication use, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) and osteoarthritis knee and hip quality of life questionnaire (OAKHQOL) questionnaires over a period of 1 year post-treatment or up to the time of surgery. Pain and recovery post surgery will be monitored as well in patients who do get the Total Knee Arthroplasty (TKA) before the 1 year mark.

Conditions

Osteoarthritis, Knee

Keywords

artery embolization; nerve ablation

Outcome Measures

Primary Outcomes (3)

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

  Assessment of changes in pain Visual Analog Scale (VAS - scale 0-10 with 10 being the highest degree of pain) scores between groups having undergone embolization versus ablation versus sham procedures

  1 year

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

  Assessment of changes in pain and functionality score using Western Ontario and McMaster Universities Arthritis Index scores (WOMAC - scale 0-96 with 96 being the most worse pain/functionality) between groups having undergone embolization versus ablation versus sham procedures

  1 year

• Changes in pain medication use in geniculate artery embolization versus nerve ablation vs sham

  Assessment in changes in dose (mg) of anti-inflammatory pain meds used between groups having undergone embolization versus ablation versus sham procedures

  1 year

Secondary Outcomes (3)

• Comparison of incidence of complications in geniculate artery embolization vs geniculate nerve ablation vs sham

  1 year

• Changes in VAS pain scores after TKA in geniculate artery embolization vs geniculate nerve ablation vs sham

  3 months post-surgery

• Changes in quality of life in geniculate artery embolization versus nerve ablation vs sham

  1 year

Study Arms (3)

Sham procedure

SHAM COMPARATOR

The patient will be placed on the procedural table as for the other arms. They will be blinded to what is occuring around them. A script detailing the procedure verbally will be followed by the interventionalists to "waste" time, but the only actual medical act that will be done is freezing of the skin around the knee (as for nerve ablation procedure) and at the groin (as for embolization procedure). Dressings will be applied at the knee and groin area.

Procedure: Skin infiltration of local anesthetic at groin and knee

Geniculate artery embolization

ACTIVE COMPARATOR

The patient will be placed on the procedural table as for the other arms. They will be blinded to what is occuring around them. They will undergo a similar script than everyone one else with freezing of the skin around the knee (as for the ablation procedure) and at the groin and in this group a geniculate artery embolization will be performed via an intraarterial access and use of embolization microspheres injected into the hypervascular arteries feeding the knee joint. Dressings will be applied at the knee and groin area.

Procedure: Geniculate artery embolization; Procedure: Skin infiltration of local anesthetic at groin and knee

Geniculate nerve ablation

ACTIVE COMPARATOR

The patient will be placed on the procedural table as for the other arms. They will be blinded to what is occuring around them. They will undergo a similar script than everyone one else with freezing of the skin around the knee and at the groin (as for the embolization procedure) and in this group a geniculate nerve ablation will be performed by advancing a radiofrequency ablation (RFA) needle at three locations alongside the tibia and femur where the nerves course and ablation performed. Dressings will be applied at the knee and groin area.

Procedure: Geniculate nerve ablation; Procedure: Skin infiltration of local anesthetic at groin and knee

Interventions

Geniculate artery embolization PROCEDURE

Under fluoroscopic guidance and angiographic imaging, a microcatheter is used to select all the arteries feeding the affected knee and Embosphere (100-300um) particles are injected to obtaining pruning of the hypervascular tissues arteries.

Geniculate artery embolization

Geniculate nerve ablation PROCEDURE

Under fluoroscopic guidance, a Cool-tip RFA ablation needle is advanced such that it touches the femur at the condylar convexity on each side and the tibia at the tibial plateau convexity on the medial side. The ablation is performed to obtain an approximate zone of ablation of 2cm.

Geniculate nerve ablation

Skin infiltration of local anesthetic at groin and knee PROCEDURE

Freezing of the skin will be performed at the groin (as prior to an arterial access for embolization procedure) and at three areas around the knee (as prior to insertion of the ablation needles for nerve ablation procedure).

Geniculate artery embolization; Geniculate nerve ablation; Sham procedure

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with knee osteoarthritis awaiting knee replacement surgery (expected to be more than a 3m waiting time) presenting with knee pain that patients consider unsatisfactorily managed by routine oral pain medications or cannot tolerate such medications.
• Patients 18 y.o. or older

You may not qualify if:

• Patients who are expected to have TKA surgery within 3 months.
• Patients in whom the anatomy prevents either procedure
• Vascular anatomy that prevents vascular access such as occluded vasculature to the leg
• Skin or deep infection that would prevent placement of needles
• Suspected concomitant infected knee joint or other signs of infections such as fever
• Patients with uncorrectable abnormal coagulation status (INR \>1.5 and plt \< 50,000 without use of anticoagulation agents)
• Patients who have known severe allergy to the anesthetic agent or contrast
• Patients with pre-existing conditions, which, in the opinion of the investigator, interfere with the conduct of the study
• Patients who are uncooperative, cannot follow instructions, or who are unlikely to comply with follow-up appointments or fill-out the post-procedural pain questionnaires
• Patients with mental state that may preclude completion of the study procedure or be unable to provide informed consent

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (2)

McGill University Health Centre

Montreal, Quebec, H3A3J1, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A2T9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The referring surgeons, nursing staff, and the patient will all be blinded to outcome. Interventional radiologists and anesthetists performing the procedure itself cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor/Staff Interventional Radiologist

Model Details: three-arm prospective double-blinded randomized comparative trial

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 10, 2020
• Study Start: February 23, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)