Status:
WITHDRAWN
Geniculate Nerve Ablation vs Geniculate Artery Embolization vs Sham for Knee Osteoarthritic Pain
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 k...
Detailed Description
This is a three-arm prospective double-blinded randomized comparative trial. Experienced interventional radiologists and anesthetists at the MUHC and study affiliated centers will carry out all interv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04662840
Start Date
February 23 2021
End Date
December 1 2022
Last Update
June 2 2023
Active Locations (2)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H3A3J1
2
McGill University Health Centre
Montreal, Quebec, Canada, H4A2T9