WithdrawnPhase 4

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

Stopped: Difficulty in getting participants to accept participating

Canada0Started 2021-02-23

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Patients who are expected to have TKA surgery within 3 months.
. Patients in whom the anatomy prevents either procedure
. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year

Trial details

NCT IDNCT04662840

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Patients who are expected to have TKA surgery within 3 months.
. Patients in whom the anatomy prevents either procedure
. 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)

What they're measuring

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

Timeframe: 1 year

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

Timeframe: 1 year

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

Timeframe: 1 year