This study wants to find out if a new treatment called Nexsphere-F can safely reduce knee pain in people with arthritis. It will also compare how well this treatment works compared to a standard steroid injection.
Knee arthritis can cause ongoing pain, swelling, and trouble with movement. Some people do not get enough relief from usual care, such as medication or injections. This study wants to learn if a new treatment that blocks small blood vessels in the knee that may be related to pain. This may help reduce swelling and improve symptoms. If you wish to join, you will first have a screening visit to see if you can take part. During this visit, the study team will review your health history, check your overall health, and give you imaging tests like an X-ray or MRI. You wuill be asked questions about your knee pain and how it affects your daily life. If you are able to join, you will be placed into 1 of 2 groups by chance, like flipping a coin. You will either receive the Nexsphere-F treatment or a corticosteroid injection in your knee. If you receive Nexsphere-F, you will have a procedure where a small tube is placed into a blood vessel near your groin. The study doctor will guide the treatment to the blood vessels in your knee. The procedure takes about 45 minutes, and you will go home the same day. If you receive the steroid injection, it will be given during a clinic visit. You will return to the clinic for a several follow up visits. At these visits, the study team will check your knee pain, review your health and treatment, and ask you to fill out questionnaires about your symptoms and quality of life. Your total time in the study will be about 12 to 18 months. You will be paid up to $425 (no cross over) or up to $525 (cross over) if you complete all study visits. If you leave the study early, you will be paid only for the visits you complete.
You may be able to join this study if you have knee arthritis and continue to have pain after the usual treatment. You must be able to point to where your knee hurts and be able to come to CU Anshutz for in person visits and testing. You may not be able to join if you need knee surgery or have certain health conditions that could make the study unsafe. The study team will review your health history and test results to make sure you can join.
Protocol Number: 25-1179
More information available at ClinicalTrials.gov: NCT06872567
Principal Investigator