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Procedure
Geniculate artery embolization for Osteoarthritis
Phase 4
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is comparing results of three different procedures aimed at improving knee pain in patients with osteoarthritis who are awaiting a knee replacement. The procedures are a sham procedure, a geniculate artery embolization procedure, or a geniculate nerve ablation procedure.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in knee pain post geniculate artery embolization versus nerve ablation vs sham
Changes in knee pain/functionality in geniculate artery embolization versus nerve ablation vs sham
Pharmaceutical Preparations
Secondary outcome measures
Changes in VAS pain scores after TKA in geniculate artery embolization vs geniculate nerve ablation vs sham
Changes in quality of life in geniculate artery embolization versus nerve ablation vs sham
Comparison of incidence of complications in geniculate artery embolization vs geniculate nerve ablation vs sham
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Geniculate artery embolizationActive Control2 Interventions
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.
Group II: Geniculate nerve ablationActive Control2 Interventions
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.
Group III: Sham procedurePlacebo Group1 Intervention
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.
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
444 Previous Clinical Trials
159,548 Total Patients Enrolled
3 Trials studying Osteoarthritis
128 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
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