Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis

This study is looking for adults aged 40 to 90 who have been diagnosed with moderate to severe knee osteoarthritis. Your doctor will use X-rays to confirm the severity of your arthritis, and you must be experiencing knee pain when walking or have significant difficulties with your daily knee function.

You won't be able to join if you have very mild arthritis or if you're planning to have knee surgery in the next six months. Also, certain other health conditions, like some autoimmune diseases (e.g., rheumatoid arthritis or lupus) or blood clotting problems, would mean you can't take part. We also can't include people who have had certain other knee injections (like PRP, hyaluronic acid, or steroid injections) within specific timeframes recently.

It's important that you understand what the study involves and are able to read and fill out questionnaires. If you have had any infections in your knee recently, or if your knee is currently red or warm, you wouldn't be suitable for the study.

If you join this study, you'll receive a single injection into your knee. You won't know if you're getting the new combination treatment, an existing treatment (Hylan G-F 20), or a dummy injection (placebo) – this helps us get fair results. You'll have scheduled visits to the clinic at the start, and then one, three, and six months after your injection.

During these visits, the study team will check on your knee pain, how well you can move, and your general quality of life. This will involve answering questionnaires about your symptoms. Some participants will also have a special walking test (gait analysis) to see how the treatment affects their movement, but this will only happen at one study centre. The total time you'll be involved in the study is about six months from the day of your injection.