RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, is pleased to announce the results of a recent randomized prospective clinical study of BioCleanse ®-processed bone-patellar tendon-bone (BTB) allografts used in anterior cruciate ligament (ACL) reconstruction surgery. The study was published in the peer reviewed journal, Knee Surgery, Sports Traumatology, Arthroscopy, in December 2012.
The article compares the clinical outcomes of BTB allografts processed using RTI’s patented BioCleanse Tissue Sterilization Process with a control group consisting of aseptically-processed allografts from the three U.S. tissue banks that provide this type of allograft. According to the American Association of Tissue Banks’ 13 th edition of Standards for Tissue Banking, aseptic processing refers to the processing of tissue using methods to prevent, restrict or minimize contamination with microorganisms from the environment, processing personnel, and/or equipment. A total of 67 patients undergoing ACL reconstruction at six independent investigation sites were evaluated at six, 12 and 24 months. After randomization, 24 patients received aseptic BTB allografts and 43 patients received BioCleanse-sterilized allografts.
“These results indicate that the sterilization process, BioCleanse, did not demonstrate a statistical difference in clinical outcomes for the BTB allograft at two years,” authors find. “The BioCleanse process may provide surgeons with allografts clinically similar to aseptically-processed allograft tissue with the benefit of addressing donor-to-recipient disease.”
According to Millennium Research Group’s “U.S. Markets for Orthopedic Soft Tissue Solutions 2011” report, more than 457,400 ACL reconstructions are performed annually in the U.S., with 21 percent of those using allograft implants. According to the authors, the use of allograft tissue in ACL reconstruction has been noted to decrease operating time, eliminate donor site morbidity and increase the tissue available for multi-ligament cases. The one disadvantage compared with autografts (the use of one’s own tissue) or metal and synthetic implants, is that disease can be transmitted as a result of an aseptically-processed allograft.