A Phase III FDA Trial
Tulsa Bone & Joint is now participating in a randomized, multicenter, partially blinded, Phase III FDA trial to evaluate the effectiveness of NOVOCART 3D versus microfracture surgery for cartilage injuries of the knee.
NOVOCART 3D is considered an investigational new product by the FDA; though it has been used successfully in Europe since 2003.
What is NOVOCART 3D?
NOVOCART 3D is a combination product that is cell based therapy employing autologous cultured chondrocytes in a type1 collagen scaffold. Chondrocytes are the cells that make cartilage – the friction-free joint surface that allows painless joint function. Autologous chondrocyte implantation (ACI) is a viable treatment for cartilage damage in the knee joint available in the United States since 1995. The procedure uses tissue engineering to grow the patient’s own cartilage cells in the laboratory for later implantation. Typically ACI requires a flap of bone tissue or a patch to harness the cells within the defect. Next generation therapies, including NOVOCART 3D, employ a matrix, or scaffolding of collagen fibers, a natural joint substance, to support the growth of healthy cartilage cells.
What is a chondral injury of the knee?
A chondral injury is a cartilage tear in the knee joint. The knee, like all other joints, is lined with a smooth gliding surface of hyaline cartilage. Hyaline cartilage is made up of a microscopic array of Type II collagen and water to allow pain-free joint range of motion and shock absorption. Damage to the cartilage can occur with trauma or overuse of the knee joint; and may be associated with ligament (such as ACL) or meniscal tears. Up to 60% of arthroscopic knee surgeries may detect some level of cartilage damage within the knee joint. Unfortunately, cartilage healing is not possible and once damaged, the cartilage may never repair itself.
What is Microfracture surgery?
Microfracture surgery is a technique for cartilage repair that involves recruiting bone marrow cells to heal the defect. It is considered a first-line treatment, and is the standard of care for cartilage repair. An awl is used to make 3-4 millimeter penetrations in the underlying bone. Bleeding from the bone holes allows bone marrow cells to fill the cartilage defect creating a scar of hyaline-like, fibrocartilage. The resulting fibrocartilage consists of Type I collagen fibers; not the natural Type II collagen of healthy hyaline cartilage.
How do I know if I’m eligible?
A thorough assessment of your medical history, your knee joint and your injury is necessary before participating in the study. If you are interested in participating in the study, please contact our Research Coordinator at 918-392-1411.
For more information, visit the Clinical Trials.gov website.