Genicular Artery Embolization vs Nerve Ablation Intervention (GENI) for Knee Osteoarthriti
The genicular artery embolization vs nerve ablation intervention (GENI) knee OA study is a three-arm randomized controlled trial to evaluate symptoms of knee osteoarthritis (OA) in patients after receiving one of three interventions: sham procedure, geniculate artery embolization (GAE) or genicular nerve phenol nerve a
| Condition(s) | Knee Osteoarthritis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The genicular artery embolization vs nerve ablation intervention (GENI) knee OA study is a three-arm randomized controlled trial to evaluate symptoms of knee osteoarthritis (OA) in patients after receiving one of three interventions: sham procedure, geniculate artery embolization (GAE) or genicular nerve phenol nerve ablation (PNA). The main question\[s\] the study aims to answer are: * Does GAE or genicular nerve PNA result in OA symptom alleviation compared to sham procedure? * Are there molecular or imaging biomarkers that aid in predicting treatment response for GAE or genicular nerve PNA? Subjects (N=150) patients with knee OA, resistant to non-surgical treatment for at least 3 months will be randomized 1:1:1 to either after GAE, genicular nerve PNA or sham procedure. Clinical outcome |
| Who can participate | Inclusion 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 Exclusion Criteria: * 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) * Irreversibl |
| Ages | 40 Years |
| Sex | All |
| Lead sponsor | David Clinkard |
| Locations | Kingston, Ontario, Canada |
| Start date | 2023-12-01 |
| NCT ID | NCT06166628 |
| Official listing | https://clinicaltrials.gov/study/NCT06166628 |