Genicular artEry embolisatioN in patiEnts With oSteoarthrItiS of the Knee II
This clinical study is designed as a double-blind sham controlled randomised trial with the option of sham group crossover to receive the GAE treatment at 6 months after unblinding. This study will determine if embolisation of abnormal neovasculature arising from branches of the genicular arteries reduces pain in patients with knee osteoarthritis. The study patient population will consist of up to 110 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or 2 mL of saline in the sham arm. At 6 months, all subjects in the sham arm will be allowed to cross-over and receive the embolisation procedure with a follow-up duration of 18 months. The total planned study duration is 3.5 years.
⁃ ALL inclusion criteria below need to be fulfilled for the patient to participate in the study.
• Participant is willing and able to give informed consent for participation in the study.
• Participants aged 45 years or above.
• Grade 1-3 knee OA on X-ray as per Kellgren-Lawrence Grading Scale
• Knee pain for at least 3 months resistant to conservative non-surgical treatment (e.g., physiotherapy, steroid injections, weight loss programs, PRP (platelet-rich plasma) injections)
• Be able to lie flat for at least 6 hours-this will be assessed by asking how participants sleep (bed, chair recumbent, semi-recumbent) and assessing what prevents them from lying flat overnight (breathlessness, back pain, etc)
• Minimum score of 50 on baseline 0 - 100 VAS