Cartilage Repair Device
Damage to articular cartilage by acute or chronic injury causes pain and limits knee function. If left untreated, damage to the articular cartilage may further progress
down a degenerative pathway, resulting in painful osteoarthritis. Physicians and scientists have been frustrated for decades by the inability of damaged articular cartilage to heal itself as it lacks both a blood supply and an appropriate population of repair cells.
Today’s techniques for treating chondral or osteochondral defects commonly include microfracture and transplantation procedures. Microfracture involves puncturing the subchondral bone to stimulate blood flow to the defect area. Transplantation techniques utilize the patients own tissue (autograft) or cadaveric tissue (allograft) to
replace damaged tissue. These techniques typically provide a temporary relief by creating a fibrocartilaginous repair that is biomechanically and biochemically inferior to normal articular cartilage. Additionally, concerns remain about limited graft availability, morbidity at the autograft donor site, graft hypertrophy, the need for multiple surgical interventions, excessive cost or limited surgical locations. These current techniques, though beneficial in temporarily reducing patient pain, cannot truly be considered successful long-term solutions.
Kensey Nash Corporation’s Cartilage Repair Device is designed to address many of the deficiencies found in today’s cartilage repair procedures. The Cartilage Repair Device (CRD) is a unique synthetic bioresorbable implant designed to address chondral and osteochondral defects. This CRD technology utilizes a biphasic design that contains two discrete layers, each specifically engineered to favor the growth of the histologically distinct tissues of articular cartilage and subchondral bone. The chondral phase consists of a unique Type I bovine collagen matrix that provides a malleable, flexible substratum that allows cell infiltration and de novo formation of hyaline tissue. The subchondral phase consists of b-TCP (tricalcium phosphate) mineral suspended within a porous bioresorbable synthetic polymer scaffold. This matrix provides an appropriate mechanical and chemical environment to facilitate the influx of cells and remodeling into normal bony architecture, an important component in a successful cartilage regeneration effort.
Significant preclinical research and development has yielded a completely bioresorbable, acellular, biphasic scaffold. These studies have been conducted with some of the premier academic institutes in the US. The success of these studies has prompted KNC to seek IDE approval with the United States Food and Drug Administration to begin a pivotal human study to gain a cartilage repair indication. Our clinical trial will commence in mid 2009.
For further information, please use the contacts below.
Surgeons:
For surgeons interested in study details and information related to participation please follow this URL: Click here to request info about cartilage repair device.
Patients:
Please visit the www.clinicaltrials.gov website for eligibility information and the location of participating clinical investigators, search by keyword, "cartilage".
"CAUTION - This device is not available for use in the U.S.
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