

NOVOCART® 3D Study: A Phase 3 Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART® 3D, Compared to Microfracture in the Treatment of Articular Cartilage Defects
Physician
Orthopaedics
Study Coordinator
Susan Hahn
484-526-7825
Susan.Hahn2@sluhn.org
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Synopsis: This is a research study of an investigational biologic/device combination product called Novocart® 3D. This device is being tested for repair of knee cartilage defects. The purpose of this research study is to assess the pain, stiffness and physical function of the affected knee. Randomization, or a method based on chance, by which study participants will receive one of two possible surgical procedures. One surgical procedure is investigational which means it is not FDA approved in the United States, utilizes the Novocart® 3D autologous cartilage implant system. The 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 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 other possible procedure is called Microfracture and is one of the current standard of care options to treat the condition. Both surgical procedures will be followed by pain and knee function assessments and a course of physical rehabilitation.
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