RTI Biologics, Inc. (RTI), a sterile biological implants company, is planning to complete the trial named “Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle” for CR-Plug by March 2011. The trial is currently recruiting participants. The trial objective is to determine the ability of the allograft plug for the treatment of a cartilage injury in the knee.
This non-randomized, open label, single group assignment, safety/efficacy phase III study is conducted in US with the estimated enrollment of 20 patients. The trial Principal Investigators include Jack Farr, MD, PhD from OrthoIndy, Inc, Ralph A Gambardella, MD from Kerlan Jobe Orthopaedic Clinic, Stewart Weinerman, MD from Colorado Orthopedic Consultants.
CR Plug is a human bone allograft intended to fill the hole and repair the defects created at the harvest site during the Osteochondral Autograft Transfer System(OATS) procedure. This sterile biomaterial product consists of entirely human allograft bone tissue.