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To learn more about this study.

About the Study

Medical researchers are conducting a study to determine the effectiveness of an investigational implant for individuals with knee pain.

Why Participate?

You may have an option to help improve knee pain after meniscus surgery.

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About the Study

Introduction

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.

Non-Surgical Care

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.

Surgical Care

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 30 to 75 years of age
• Are still in pain after your meniscus surgery
• Had meniscus surgery 6 months ago or longer

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Why Participate?

There are potential benefits and risks with any medical device and procedure. Trial personnel can speak with you about the benefits and risks.

• You will receive treatment from a specialist in the field of orthopedics.

• Your doctor will be able to carefully monitor your treatment using advanced diagnostic techniques.

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Am I Eligible?

Only the Research Trial Staff can fully determine if you qualify to enroll in the study, however answering these 5 questions now can help determine your eligibility.


Am I Eligible?

Only the study doctor can fully determine if you qualify to enroll in the study, but answering these 6 questions now can help determine your eligibility.