Geniculate nerve ablation 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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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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