Geniculate Nerve Ablation vs Geniculate Artery Embolization vs Sham for Knee Osteoarthritic Pain (NCT04662840) | Clinical Trial Compass
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 range18 Years
SexALL
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)
✕. 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
✕
What they're measuring
1
Changes in knee pain post geniculate artery embolization versus nerve ablation vs sham
Timeframe: 1 year
2
Changes in knee pain/functionality in geniculate artery embolization versus nerve ablation vs sham
Timeframe: 1 year
3
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
. 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