Introduction: DeNovo NT Graft

The DeNovo Natural Tissue (NT) Graft is derived from articular cartilage allograft.^1,2 The allograft articular cartilage is mechanically particulated into pieces of tissue and stored in a proprietary storage medium developed by ISTO Technologies, Inc. (St. Louis, Mo., United States).

The tissue is procured from donors 13 years old or younger (no fetal tissue), as more robust collagen type II and proteoglycan production occurs in cartilage from donors in this age group than in adult cartilage tissue.

As an allograft tissue, DeNovo NT is not required to be preapproved for clinical use by the Food and Drug Administration (FDA) but complies with the FDA regulations for human tissue products and the American Association of Tissue Banks (AATB) standards. The packages of DeNovo NT graft are shipped in controlled temperature containers (distributed by Zimmer, Inc.).

As tissue comprising the DeNovo NT graft is analyzed in the same manner as fresh stored osteochondral allograft, per AATB standards and FDA regulations, it is released for use only after all viral screening and sterility tests are completed. Similar to other fresh allograft tissues such as fresh osteochondral allografts,^3–6 the tissue has a limited shelf life.

The aseptically prepared DeNovo NT graft is placed in an inner sterile package filled with the storage medium. The sterile inner package is then sealed within a protective outer plastic package that is sterile inside.

Preoperatively, the lesion sizes are documented. The lesion areas are calculated and used to order the separate packets of DeNovo NT graft. Each package contains particulated cartilage pieces to cover an area of up to 2.5 cm².

The DeNovo NT graft has been implanted to repair cartilage defects in the knee, ankle, hip, shoulder, elbow, and great toe, with the earliest surgery performed in May 2007.

Technique Overview