Active not recruitingPHASE3INTERVENTIONAL

NOVOCART 3D Treatment Following Microfracture Failure

This study is for adults aged 18 to 65 who have a specific knee problem called an articular cartilage defect. If you previously took part in another study (AAG-G-H-1220) and were treated with a method called Microfracture, but that treatment wasn't successful, this new study might be for you. It's an extension of the earlier study and focuses on giving those specific participants a different treatment called NOVOCART 3D. The main goal is to see how well NOVOCART 3D works for people when Microfracture didn't provide the desired results for their knee cartilage issue. All eligible participants will receive the NOVOCART 3D treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Aesculap Biologics, LLC

Enrolment target

Start

30 Nov 2018

Estimated completion

01 Jan 2029

Articular Cartilage Defect

What is this study about?

Imagine your knee joint has a smooth surface called cartilage that helps it move easily. If this cartilage gets damaged, it can cause pain and difficulty moving. Doctors sometimes try to fix this with a procedure called Microfracture. This involves making tiny holes in the bone near the damaged cartilage to encourage new cartilage to grow.

However, Microfracture doesn't always work for everyone. This particular study is designed for adults who were part of an earlier research study (called AAG-G-H-1220) where they received Microfracture treatment for their knee cartilage problem, but unfortunately, it didn't heal as hoped. This new study offers these specific individuals a different treatment option called NOVOCART 3D.

NOVOCART 3D is a different way to try and repair damaged cartilage. By studying its effects in people for whom Microfracture wasn't successful, researchers hope to learn if NOVOCART 3D could be a better alternative for this group. The aim is to understand how this new treatment performs and if it can help improve knee function and reduce pain.

Key takeaways

This study is for adults (18-65) with knee cartilage damage.
You must have been in a previous study (AAG-G-H-1220) and had Microfracture.
Your Microfracture treatment in the previous study must have failed.
All participants in this study will receive the NOVOCART 3D treatment.
It aims to see if NOVOCART 3D helps when Microfracture didn't work.

Who may be eligible?

This study is specifically for adults between the ages of 18 and 65. To be considered, you must have previously participated in an earlier research study known as AAG-G-H-1220. Crucially, in that previous study, you must have been in the group that received Microfracture treatment for your knee cartilage issue, and that treatment must not have worked as expected. You'll also need to willingly agree to take part in this new study.

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.

I am between 18 and 65 years old.
I participated in the previous study called AAG-G-H-1220.
In study AAG-G-H-1220, I received the Microfracture treatment for my knee.
My Microfracture treatment in AAG-G-H-1220 did not work as expected.
I have not had other cartilage repair procedures on the knee being studied.
My damaged cartilage area is not larger than 9 square centimetres (about the size of a £2 coin).

Answer every question to see your result.

What does participation involve?

If you join this study, it means you'll be receiving the NOVOCART 3D treatment. The study is an extension of the one you were in before, so it will involve follow-up appointments and checks by the medical team to see how you are getting on with the new treatment. This will likely include examinations, questionnaires about your knee pain and function, and potentially scans or x-rays to track the healing of your cartilage. The exact number and frequency of visits will be explained to you, but typically, clinical trials involve several appointments over a period to monitor your progress and ensure your safety. The total duration of your involvement will be clearly outlined.

Potential risks and benefits

Potential benefits of joining this study include the chance to receive a new treatment (NOVOCART 3D) for your knee cartilage problem after your previous Microfracture treatment was unsuccessful. This new treatment might help improve your knee function and reduce pain. However, like all medical procedures, there are potential risks associated with the NOVOCART 3D treatment and any related interventions, which your doctors will discuss in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (5)

Rush University Medical Center
Verified postcode
Chicago, United States
Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States
Alpine Orthopaedics
Verified postcode
North Logan, United States
University of Alberta
Verified postcode
Edmonton, Canada
Dalhousie University
Verified postcode
Halifax, Canada

Common questions

What is NOVOCART 3D?

NOVOCART 3D is a specific treatment designed to help repair damaged cartilage in the knee. The study aims to see how well it works.

Why is this study only for people who had Microfracture before?

This study is a follow-up for specific participants of a previous study where Microfracture didn't fully heal their knee cartilage. It's looking at NOVOCART 3D as a different option for them.

Will I get Microfracture again if I join this study?

No, if you join this study, you will receive the NOVOCART 3D treatment, specifically because your Microfracture treatment was not successful.

How long will I be in the study if I participate?

The exact length of time will be explained to you, but studies like this usually involve monitoring your progress over a period of time with several follow-up appointments.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point, and it will not affect your regular medical care.