Health Problem: Articular cartilage is a resilient connective tissue that covers and lubricates joints at the interfaces of long bones to reduce friction during movement. Articular cartilage lesions have been reported in 4% to 6% of all knee arthroscopies (up to 36% in athletes). Chondral and osteochondral lesions of the ankle are commonly related to ankle sprain, affecting 1 in every 10,000 individuals in the United States daily, with up to 50% of ankle fractures and sprains resulting in some form of articular cartilage lesion of the talus. Osteoarthritis, a potential complication from untreated cartilage defects, is the most common type of arthritis among adults in the United States, affecting a hand, knee, or hip joint in over 30 million adult patients.
Technology Description: The DeNovo NT tissue graft is a tissue product intended to restore focal articular cartilage defects in the knee, hip, ankle, elbow, metatarsophalangeal joint, or shoulder following damage by injury or arthritic processes. It provides an early intervention option for the repair of articular damage. The product is composed of minced, 1 cubic millimeter pieces of human particulated juvenile cartilage obtained from the femoral condyles of individuals up to 13 years of age. Implanted in a single-stage procedure with fibrin fixation, DeNovo NT eliminates the need for harvesting a periosteal flap or tissue or cells from areas of undamaged cartilage.
Controversy: Lack of natural regeneration and limited treatment options makes biological repair of cartilage lesions a significant challenge. Although DeNovo NT provides an early intervention option for articular repair that does not require the harvesting of periostial flaps or tissues or cells, the high cost of the intervention and limited insurance coverage could pose as a barrier for patients unable to pay for the procedure. Tissue availability, disease transmission, and potential for immunological reactions must also be considered.
Key Questions:
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Is the DeNovo NT tissue graft effective in treating articular cartilage lesions of the knee or ankle?
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How does the DeNovo NT tissue graft compare with clinical alternatives to treat articular cartilage lesions of the knee or ankle?
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Is the DeNovo NT tissue graft safe for treating articular cartilage lesions of the knee or ankle?
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Have definitive patient selection criteria been identified for the DeNovo NT tissue graft?
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