Active not recruitingPHASE3INTERVENTIONAL

NOVOCART®3D for Treatment of Articular Cartilage of the Knee

Are you experiencing knee pain due to damaged cartilage? This study is looking at two different approaches to help fix problems with the smooth, slippery tissue called cartilage in your knee. One is a new treatment called NOVOCART 3D, which involves a special gel. The other is a more common surgical procedure known as microfracture. The main goal of this research is to compare these two options to see which one works best for reducing pain and helping you move your knee better. We also want to make sure both treatments are safe for people. If you have a specific type of cartilage damage in your knee, this study might be of interest to you.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Aesculap Biologics, LLC

Enrolment target

233

Start

01 Dec 2013

Estimated completion

01 Dec 2027

Articular Cartilage of the Femoral Condyle Between 2-6cm2

What is this study about?

Imagine the end of your bones in your knee are covered in a smooth, rubbery layer, a bit like a cushion. This is called cartilage, and it helps your knee move easily without pain. Sometimes, this cartilage can get damaged, perhaps from an injury or wear and tear, leading to pain and stiffness.

This study is looking into ways to help repair these damaged areas. We're comparing two main types of treatment for certain cartilage problems in the knee. One is a new approach called NOVOCART 3D, which is a special gel that works to help the cartilage heal. The other is a common surgical procedure known as microfracture. This involves making tiny holes in the bone beneath the damaged cartilage to encourage new repair tissue to grow.

The main aim of this research is to understand if one of these treatments is better than the other at reducing your knee pain and improving how well you can use your knee. We also want to make sure that both treatments are safe for people who have these types of cartilage issues. By taking part, you could help doctors learn more and potentially improve treatments for many others with similar knee problems in the future.

Key takeaways

New study comparing two knee cartilage treatments: NOVOCART 3D gel and microfracture surgery.
Aims to find out which treatment is better for pain and knee function.
Participation involves being randomly assigned to one treatment and then followed for five years.
Open to adults aged 18-65 with specific knee cartilage damage.
Regular check-ups and assessments will be part of the study.
You can withdraw from the study at any point.

Who may be eligible?

To join this study, you need to be an adult, aged between 18 and 65 years old. The study is for people who have a specific type of cartilage damage in their knee, on a part of the thigh bone called the femoral condyle. This damaged area needs to be a certain size – not too small and not too big.

There are also some reasons why you might not be able to join. For example, if your knee is very wobbly (unstable), if you have certain types of arthritis, or if you have conditions that affect your immune system. You also wouldn't be able to join if you've already had certain types of knee surgery to repair cartilage, like mosaicplasty or previous microfracture surgery.

Also, if you have other ongoing serious health problems that might affect your healing or make it difficult to properly check the results of the treatment, you might not be suitable for this study. The research team will carefully check all of these points to make sure the study is right for you and that it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you have cartilage damage in your knee on a part called the femoral condyle, between 2 and 6 square centimetres?
Do you NOT have severe problems with your immune system or other major illnesses?
Have you NOT had certain previous knee surgeries like mosaicplasty or autologous chondrocyte implantation (ACI)?
Is your knee joint generally stable (not wobbly)?
Do you NOT have certain types of arthritis in your knee?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will first have some tests to make sure you're suitable. Once you're accepted, you'll be randomly assigned to receive one of two treatments: either the NOVOCART 3D gel or the microfracture surgery. You won't get to choose which one you receive, as this helps make the study fair.

After your treatment, you will be carefully looked after by the study team. You'll have regular check-ups and assessments over a period of five years. These appointments will help the doctors understand how well your knee is healing, how your pain is, how well you can move your knee, and to check for any side effects. You might be asked to fill out questionnaires about your knee and have physical examinations. The total length of your participation in the study from start to finish will be five years.

Potential risks and benefits

Taking part in this study could offer you a potential benefit by providing a treatment for your knee cartilage damage, and you'll receive careful monitoring of your knee by specialists. However, as with any medical procedure, there are potential risks, including those associated with surgery and the possibility that the treatment might not work as well as hoped, or could have side effects. You will be given full information about these risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

Grossmont Orthopaedic Medical Group
Verified postcode
La Mesa, United States
UCLA
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Los Angeles, United States
Stanford Medicine
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Redwood City, United States
Cu Sports Medicine
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Denver, United States
Yampa Valley Medical Center
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Steamboat Springs, United States
Tenet Florida Physician Services
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Boca Raton, United States
Paley Orthopedic and Spine Institute
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West Palm Beach, United States
Saint Alphonsus Medical Group
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Meridian, United States
Rush University Medical Center
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Chicago, United States
Northshore University Health System
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Evanston, United States
University of Kentucky
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Lexington, United States
Ochsner Health System
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New Orleans, United States

Common questions

What is cartilage and why is it important?

Cartilage is the smooth, flexible tissue that covers the ends of your bones in joints like your knee. It helps your bones glide smoothly past each other and acts like a shock absorber, preventing pain and allowing easy movement.

What is the difference between NOVOCART 3D and microfracture?

NOVOCART 3D is a newer treatment involving a special gel designed to help cartilage regrow. Microfracture is a standard surgical technique where tiny holes are made in the bone to encourage new repair tissue to form.

How long will I be involved in the study?

If you join the study, you will be followed up and have regular checks for a total of five years after your treatment.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to either the NOVOCART 3D treatment or the microfracture surgery. This is like flipping a coin and helps make the study fair and scientific.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.