About the Study
After meniscus surgery, many patients still suffer from persisting knee pain that can seriously affect their daily lives. Non-surgical treatment can be helpful in addressing these symptoms. The meniscus implant has been developed as a new treatment alternative for patients with persistent knee pain following meniscus surgery.
This implant mimics the function of the natural meniscus and is made from medical grade polymers. It has been used in Europe since 2008 and is now undergoing a clinical trial in the U.S.
How does the study work?
Once selected, you will be randomly assigned into one of two groups; either the nonsurgical standard of care group or the meniscus implant group (surgical care group). Neither you nor your doctor can decide which treatment you will receive.
The study lasts for 24-months following your initial treatment. During this period you will be seen or contacted frequently by your doctor. At each of the 5 study visits your doctor will examine your knee, and you will be asked to complete questionnaires describing how you feel about your knee and the quality of your life.
The best standard of care will be tailored to your specific needs and condition in close cooperation with your surgeon and a physiotherapist. Besides extra examinations (surgeon visits, MRIs) your treatment may include an array of non-surgical treatments, including state-of-the-art physiotherapy programs, strengthening, low-impact aerobic exercises, and weight-loss programs, if required.
Your doctor may also prescribe drug treatments such as oral pain medication or knee injections.
If you are randomly selected to be treated with surgery, the meniscus implant will be inserted into your knee through a small incision. You may be allowed to go home the same day or the day after the operation. After surgery you will undergo a six week rehabilitation program.
Am I Eligible?
You may be eligible if you:
• Are still in pain after your meniscus surgery
• Had meniscus surgery 6 months ago or longer