SBIR Phase I: Development of Production-Ready 3D Printable Cartilage Repair Device for Clinical Use

This SBIR Phase I project will investigate the safety and efficacy of a new type of implantable medical device for cartilage repair in the knee. The implant is based on a novel material that is cartilage-like, as well 3D printed designs. Currently, cartilage damage in the knee is most effectively treated by a metallic joint replacement. However, qualifying patient age is 55 or older. There are several implants available to a younger and more active patient population, but they all suffer from major limitations such as low success rate, the size of the damage they treat, long recovery time or high cost. This project will mature an implantable device that can support weight and encouraging new bone and cartilage formation. The device is also made from a high performance yet low cost material, and 3D printing can create custom made and made to order devices that increase efficiency and further reduce cost. A low-cost device which can decrease recovery time and increase clinical success would greatly improve treatment of young patients, and prevent more advanced joint disease. The project supports the NSF?s mission by increasing knowledge surrounding the manufacturing and clinical use of biologically significant materials for orthopedics. This project will develop an ?on demand? device to adequately fill and support a critical-sized cartilage defect while quickly grafting to underlying subchondral bone, thus providing a new solution to the treatment of full-thickness cartilage tissue injury. Full-thickness cartilage lesions often are associated with a low rate of success and high patient morbidity (meaning 60% treatment failure) due to the need for adequate vasculature in the subchondral bone and integration with the cartilage graft. Researchers have used complex biomimetic nanomaterials and 3D printing to create strategies for joint repair. These materials work well in a controlled laboratory setting, but as is can only be printed using deposition or extrusion-based 3D printing techniques. This type of additive manufacturing is limited by resolution and print speed / volume when compared to commercial laser-based systems. The significance of this project is tied into improving clinical outcomes, with a more mechanically and biologically stable implant, while also addressing these manufacturing and cost issues. Thus, this project will validate the efficacy of an implantable cartilage repair device, made from new tissue growth materials and designs compatible with selective laser sintering, and provide critical scientific validation of a functional medical implant for orthopedic treatment.