Authors' objectives: Osteoarthritis is the most common type of arthritis among adults in the United States. The incidence of knee osteoarthritis is on the rise, with estimates increasing from nearly 9.3 million U.S. adults in 2005 to 11 million in 2009. Articular cartilage is a resilient connective tissue that covers and lubricates the joints at the interfaces of long bones to reduce friction during movement. Cartilaginous changes associated with age result in poorer regenerative capacity of adult cartilage compared with cartilage found in younger individuals. For repair of injured cartilage, autologous grafts are sometimes used, which involve transplantation of cartilage from another healthy joint to the diseased area. Autografts may be associated with several complications, including morbidity at the donor site, immunogenic reaction, and mismatch between the graft and the lesion, while cadaveric allografts may present problems with tissue availability, cost, and disease transmission. Description of Technology: DeNovo NT is a tissue product intended to restore focal cartilage defects in the knee, hip, ankle, elbow, metatarsophalangeal joint, and shoulder following damage by injury or arthritic processes. It is composed of minced 1–cubic millimeter (mm3) pieces of human particulated juvenile cartilage obtained from the femoral condyles of individuals up to 13 years of age. The material is screened for infectious diseases and packaged, and remains viable for several weeks after harvest. The allograft is implanted in a single-stage procedure and fixed in place with fibrin glue. Transplanted juvenile cartilage cells can migrate, proliferate, and form new cartilage that integrates with the host tissue. DeNovo NT is implanted after the base of the defect is cleared of diseased tissue down through the calcified layer of cartilage and thoroughly dried. The juvenile cartilage and fibrin glue may then be applied to the defect. Patients initially must avoid weight bearing and are required to undergo several months of a rehabilitation protocol, which varies based on which joint has been treated. Complications can include effusion, inflammation, graft rejection or delamination, graft hypertrophy, and nerve irritation or impingement. Patient Population: DeNovo NT is indicated for cartilage restoration of symptomatic articular cartilage lesions that measure 1 to 5 square centimeters (cm2) postdebridement, in patients with minimal or no bone loss. Patients with large lesions, cystic lesions, and previous failed marrow-stimulating procedures are eligible. Clinical Alternatives: Medical alternatives to DeNovo NT include rest or reduced activity, immobilization, physiotherapy, weight loss, analgesics, intra-articular injections (of platelet-rich plasma, stem cells, bone marrow aspirate concentrate, or hyaluronate), orthotic interventions, losartan, fish oil, and viscosupplements. Surgical alternatives to DeNovo NT include debridement, marrow stimulation or microfracture, implantation of autologous cartilage, other types of cartilage allografts, tissue-engineered cartilage substitutes, and knee replacement.

Project Status: Completed

Year Published: 2016

URL for published report: The report may be purchased from:http://www.hayesinc.com/hayes/crd/?crd=56066

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: HAYES, Inc.

Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218

Contact Name: saleinfo@hayesinc.com

Contact Email: saleinfo@hayesinc.com

Copyright: Winifred S. Hayes, Inc