Trial comparing treatments for Knee Osteoarthritis
Official title Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06166628
What this study is testing
- What it's testing
- This study wants to find out if blocking blood flow or nerves in the knee reduces pain better than a placebo procedure. It also looks for signs that can predict which patients will respond well to treatment.
- Who it's for
- People with knee arthritis who have tried non-surgical treatments for at least 3 months without enough relief.
- What's involved
- Participants will be randomly assigned to receive either a blood flow blocking procedure, a nerve blocking procedure, or a fake procedure. They will complete pain and symptom questionnaires at regular check-ups.
- Time commitment
- The study lasts up to two years or until knee replacement surgery, with visits at 1, 3, and 6 months, then every 6 months.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Age \> 40 years
- Able to provide informed consent
- Knee pain due to osteoarthritis for at least 6 months
- Pain refractory to conservative therapies (oral medication, or physical therapy, or activity modification) for at least 3 months with a desire for TKA
- Candidate for TKA at Hotel Dieu Hospital Site
You likely can't join if
- Current local infection
- Systemic or joint centered inflammatory disease (ie rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases)
- Current use of systemic immunosuppression therapy
- Known lower extremity vascular disease or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic...
- Irreversible coagulopathy
- Renal dysfunction as defined by GFR (eGFR) of \<30 obtained within the past 60 days
See the full eligibility criteria
- Age \> 40 years
- Able to provide informed consent
- Knee pain due to osteoarthritis for at least 6 months
- Pain refractory to conservative therapies (oral medication, or physical therapy, or activity modification) for at least 3 months with a desire for TKA
- Candidate for TKA at Hotel Dieu Hospital Site
- Able to comply with all treatments and protocol follow-up visits
- Current local infection
- Systemic or joint centered inflammatory disease (ie rheumatoid arthritis, Lupus, multiple sclerosis or other autoimmune diseases)
- Current use of systemic immunosuppression therapy
- Known lower extremity vascular disease or lower extremity symptoms thought to be secondary to arterial vascular disease (eg claudication, ischemic rest pain)
- Irreversible coagulopathy
- Renal dysfunction as defined by GFR (eGFR) of \<30 obtained within the past 60 days
- Contraindication for MR Imaging (such as claustrophobia, metallic fragment or foreign bones, implants or prosthesis)
- IV CT and/or MRI contrast allergy characterized by anaphylaxis or anaphylactoid reactions
- Pregnancy or women of childbearing potential not currently on a medically acceptable method of birth control
The study team makes the final eligibility decision.
Where it is enrolling
- Kingston, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kingston, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.