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Procedure
Geniculate Nerve Ablation vs Geniculate Artery Embolization vs Sham for Knee Osteoarthritic Pain
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
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial compares three methods for reducing knee pain in patients awaiting knee replacement surgery. It aims to find better pain relief options for those with severe knee osteoarthritis.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: 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 II: 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 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
470 Previous Clinical Trials
166,944 Total Patients Enrolled
3 Trials studying Osteoarthritis
128 Patients Enrolled for Osteoarthritis