Dr. Sherman’s patients who meet eligibility requirements are now able to participate voluntarily in a research study of an investigational biologic/device combination product called Novocart® 3D. This device is being tested for repair of knee cartilage defects.
Novocart® 3D is the cellular implant system that is being investigated in this clinical study. “Investigational” means that this study product has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authorities in the United States. The investigational treatment (Novocart® 3D) in this study has been used in Europe since 2003 to treat patients with damaged knee cartilage.
This use of Novocart® 3D involves two separate surgeries. In the first surgery, a small amount of knee cartilage about the size of a pencil eraser is removed from the affected knee and sent to sponsor’s manufacturing facility to be processed for re-implantation. Processing means cleaning and growing your cartilage cells in a sterile container, and then placing your own cells onto a 3-dimentional sponge-like scaffold. These cells are referred to as autologous chondrocytes (autologous = from yourself; chondrocytes = cartilage cells). During a second surgery, approximately three weeks later, the damaged area of your knee cartilage is cleaned and the sponge-like scaffold containing your autologous chondrocytes is implanted into the prepared space of the defect.
The purpose of this research study is to assess the pain, stiffness and physical function of your knee. You will receive one of two possible surgical procedures. One surgical procedure, which is the investigational procedure under study, utilizes the Novocart® 3D autologous cartilage implant system. The other possible procedure is called Microfracture and is one of the current standard of care options to treat your condition. Both surgical procedures will be followed by pain and knee function assessments and a course of physical rehabilitation.
It is possible that you will have significantly improved knee function and reduced pain as a result of these procedures compared to before the surgery. However, this cannot be guaranteed. The KOOS score is an index used to assess pain, and the IKDC score will assess physical function of your knee. Both of these scores include surveys for which you will be asked questions regarding your knee and your daily activities. Additional questionnaires will be given to you such as the SF-36 (short form general health survey), and other questions to assess the impact of your knee injury before and after the study procedures. The results of participants receiving Novocart® 3D will be compared to the results of participants undergoing the Microfracture procedure to see if one of the treatments result in better knee function and less pain.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.