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RTI Biologics Inc Announces Positive Clinical Results For BioCleanse-Processed BTB Allografts Used In ACL Reconstruction


Wednesday, 20 Mar 2013 08:30am EDT 

RTI Biologics Inc announced 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` 13th 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. 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% of those using allograft implants. 

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